OR26-08 Efficacy and Safety of Higher Dulaglutide Doses (3.0 MG and 4.5 MG) When Added to Metformin in Patients With Type 2 Diabetes: A Phase 3, Randomized, Double-Blind, Parallel ARM Study (Award-11)

Frias J, Ruiz L, Li Y, Yu Z, Milicevic Z, Woodward B, Cox D

Journal of the Endocrine Society8 May 2020

PMCIDPMC7209020PepBankPUB-99025267

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Summary

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Text rights: CC BY-NC-ND. Results still quote short attributed sentences.

Results from this study31

31 results from studies that gave the peptide. 31 results from people.

01HumanRandomized controlled trialEfficacy outcome
In patients with T2D, dulaglutide 1.5 mg reduced A1C by 1.53% under the efficacy estimand.
In plain wordsIn patients with T2D, A1C decreased from baseline by 1.53% with dulaglutide 1.5 mg during treatment without rescue medication.
Peptide
Dulaglutide (Trulicity)
Outcome
DecreaseA1C change, efficacy estimand
Study
n: not reported in source
Comparator
Baseline
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1.5 mg once weekly · 36 weeksAs given in this study (human).
Measurements
A1C reduction
1.53%
1.5 mg efficacy estimand
Source sentences
Summary
Using the efficacy estimand, the DU 3 mg and 4.5 mg doses were superior to the DU 1.5 mg dose for A1C change from BL (1.5 mg, 1.53%; 3 mg, 1.71% [p=0.003]; 4.5 mg, 1.87% [p<0.001]),
3 context sentences(design, population, supporting numbers)
Summary · context
The primary objective was to demonstrate superiority of once-weekly DU 3 mg and/or 4.5 mg to DU 1.5 mg for A1C change from baseline (BL) at 36 weeks (wks) in patients (pts) with inadequately controlled T2D on metformin therapy.
Summary · context
Patients were randomized (1:1:1) to once-weekly DU 1.5 mg (n=612), DU 3 mg (n=616), and DU 4.5 mg (n=614).
Summary · context
Two estimands were defined for efficacy analyses: an efficacy estimand (data on-treatment without rescue medication) and a treatment-regimen estimand (all data regardless of adherence or initiation of rescue).
Report a problemFND-9902526701
02HumanRandomized controlled trialEfficacy outcome
In patients with T2D, dulaglutide 1.5 mg reduced A1C by 1.54% under the treatment-regimen estimand.
In plain wordsIn patients with T2D, A1C decreased from baseline by 1.54% with dulaglutide 1.5 mg when all treatment data were included.
Peptide
Dulaglutide (Trulicity)
Outcome
DecreaseA1C change, treatment-regimen estimand
Study
n: not reported in source
Comparator
Baseline
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1.5 mg once weekly · 36 weeksAs given in this study (human).
Measurements
A1C reduction
1.54%
1.5 mg treatment-regimen estimand
Source sentences
Summary
Using the treatment-regimen estimand, DU 4.5 mg was superior to DU 1.5 mg for A1C change, while the DU 3 mg dose did not achieve statistical significance (1.5 mg, 1.54%; 3.0 mg, 1.64% [p=0.096]; 4.5 mg, 1.77% [p<0.001]).
3 context sentences(design, population, supporting numbers)
Summary · context
The primary objective was to demonstrate superiority of once-weekly DU 3 mg and/or 4.5 mg to DU 1.5 mg for A1C change from baseline (BL) at 36 weeks (wks) in patients (pts) with inadequately controlled T2D on metformin therapy.
Summary · context
Patients were randomized (1:1:1) to once-weekly DU 1.5 mg (n=612), DU 3 mg (n=616), and DU 4.5 mg (n=614).
Summary · context
Two estimands were defined for efficacy analyses: an efficacy estimand (data on-treatment without rescue medication) and a treatment-regimen estimand (all data regardless of adherence or initiation of rescue).
Report a problemFND-9902526704
03HumanRandomized controlled trialEfficacy outcome
In patients with T2D, dulaglutide 3 mg reduced A1C more than 1.5 mg under the efficacy estimand.
In plain wordsIn patients with T2D, dulaglutide 3 mg reduced A1C more than 1.5 mg during treatment without rescue medication.
Peptide
Dulaglutide (Trulicity)
Outcome
DecreaseA1C change, efficacy estimand
Study
n: not reported in source
Comparator
Dulaglutide 1.5 mg
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
3 mg once weekly · 36 weeksAs given in this study (human).
Measurements
A1C reduction
1.71%
3 mg efficacy estimand
A1C reduction
1.53%
1.5 mg efficacy estimand
Source sentences
Summary
Using the efficacy estimand, the DU 3 mg and 4.5 mg doses were superior to the DU 1.5 mg dose for A1C change from BL (1.5 mg, 1.53%; 3 mg, 1.71% [p=0.003]; 4.5 mg, 1.87% [p<0.001]),
3 context sentences(design, population, supporting numbers)
Summary · context
The primary objective was to demonstrate superiority of once-weekly DU 3 mg and/or 4.5 mg to DU 1.5 mg for A1C change from baseline (BL) at 36 weeks (wks) in patients (pts) with inadequately controlled T2D on metformin therapy.
Summary · context
Patients were randomized (1:1:1) to once-weekly DU 1.5 mg (n=612), DU 3 mg (n=616), and DU 4.5 mg (n=614).
Summary · context
Two estimands were defined for efficacy analyses: an efficacy estimand (data on-treatment without rescue medication) and a treatment-regimen estimand (all data regardless of adherence or initiation of rescue).
Report a problemFND-9902526707
04HumanRandomized controlled trialEfficacy outcome
In patients with T2D, dulaglutide 4.5 mg reduced A1C more than 1.5 mg under the efficacy estimand.
In plain wordsIn patients with T2D, dulaglutide 4.5 mg reduced A1C more than 1.5 mg during treatment without rescue medication.
Peptide
Dulaglutide (Trulicity)
Outcome
DecreaseA1C change, efficacy estimand
Study
n: not reported in source
Comparator
Dulaglutide 1.5 mg
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
4.5 mg once weekly · 36 weeksAs given in this study (human).
Measurements
A1C reduction
1.87%
4.5 mg efficacy estimand
A1C reduction
1.53%
1.5 mg efficacy estimand
Source sentences
Summary
Using the efficacy estimand, the DU 3 mg and 4.5 mg doses were superior to the DU 1.5 mg dose for A1C change from BL (1.5 mg, 1.53%; 3 mg, 1.71% [p=0.003]; 4.5 mg, 1.87% [p<0.001]),
3 context sentences(design, population, supporting numbers)
Summary · context
The primary objective was to demonstrate superiority of once-weekly DU 3 mg and/or 4.5 mg to DU 1.5 mg for A1C change from baseline (BL) at 36 weeks (wks) in patients (pts) with inadequately controlled T2D on metformin therapy.
Summary · context
Patients were randomized (1:1:1) to once-weekly DU 1.5 mg (n=612), DU 3 mg (n=616), and DU 4.5 mg (n=614).
Summary · context
Two estimands were defined for efficacy analyses: an efficacy estimand (data on-treatment without rescue medication) and a treatment-regimen estimand (all data regardless of adherence or initiation of rescue).
Report a problemFND-9902526708
05HumanRandomized controlled trialEfficacy outcome
In patients with T2D, A1C reduction did not differ significantly between dulaglutide 3 mg and 1.5 mg under the treatment-regimen estimand.
In plain wordsIn patients with T2D, dulaglutide 3 mg did not significantly improve A1C reduction versus 1.5 mg when all treatment data were included.
Peptide
Dulaglutide (Trulicity)
Outcome
No significant changeA1C change, treatment-regimen estimand
Study
n: not reported in source
Comparator
Dulaglutide 1.5 mg
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
3 mg once weekly · 36 weeksAs given in this study (human).
Measurements
A1C reduction
1.64%
3.0 mg treatment-regimen estimand
A1C reduction
1.54%
1.5 mg treatment-regimen estimand
Source sentences
Summary
Using the treatment-regimen estimand, DU 4.5 mg was superior to DU 1.5 mg for A1C change, while the DU 3 mg dose did not achieve statistical significance (1.5 mg, 1.54%; 3.0 mg, 1.64% [p=0.096]; 4.5 mg, 1.77% [p<0.001]).
3 context sentences(design, population, supporting numbers)
Summary · context
The primary objective was to demonstrate superiority of once-weekly DU 3 mg and/or 4.5 mg to DU 1.5 mg for A1C change from baseline (BL) at 36 weeks (wks) in patients (pts) with inadequately controlled T2D on metformin therapy.
Summary · context
Patients were randomized (1:1:1) to once-weekly DU 1.5 mg (n=612), DU 3 mg (n=616), and DU 4.5 mg (n=614).
Summary · context
Two estimands were defined for efficacy analyses: an efficacy estimand (data on-treatment without rescue medication) and a treatment-regimen estimand (all data regardless of adherence or initiation of rescue).
Report a problemFND-9902526713
06HumanRandomized controlled trialEfficacy outcome
In patients with T2D, dulaglutide 4.5 mg reduced A1C more than 1.5 mg under the treatment-regimen estimand.
In plain wordsIn patients with T2D, dulaglutide 4.5 mg reduced A1C more than 1.5 mg when all treatment data were included.
Peptide
Dulaglutide (Trulicity)
Outcome
DecreaseA1C change, treatment-regimen estimand
Study
n: not reported in source
Comparator
Dulaglutide 1.5 mg
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
4.5 mg once weekly · 36 weeksAs given in this study (human).
Measurements
A1C reduction
1.77%
4.5 mg treatment-regimen estimand
A1C reduction
1.54%
1.5 mg treatment-regimen estimand
Source sentences
Summary
Using the treatment-regimen estimand, DU 4.5 mg was superior to DU 1.5 mg for A1C change, while the DU 3 mg dose did not achieve statistical significance (1.5 mg, 1.54%; 3.0 mg, 1.64% [p=0.096]; 4.5 mg, 1.77% [p<0.001]).
3 context sentences(design, population, supporting numbers)
Summary · context
The primary objective was to demonstrate superiority of once-weekly DU 3 mg and/or 4.5 mg to DU 1.5 mg for A1C change from baseline (BL) at 36 weeks (wks) in patients (pts) with inadequately controlled T2D on metformin therapy.
Summary · context
Patients were randomized (1:1:1) to once-weekly DU 1.5 mg (n=612), DU 3 mg (n=616), and DU 4.5 mg (n=614).
Summary · context
Two estimands were defined for efficacy analyses: an efficacy estimand (data on-treatment without rescue medication) and a treatment-regimen estimand (all data regardless of adherence or initiation of rescue).
Report a problemFND-9902526714
07HumanRandomized controlled trialEfficacy outcome
In patients with T2D, 57% reached HbA1c below 7% with dulaglutide 1.5 mg under the efficacy estimand.
In plain wordsIn patients with T2D, 57% reached the HbA1c target with dulaglutide 1.5 mg during treatment without rescue medication.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableHbA1c below 7%, efficacy estimand
Study
n: not reported in source
Analysis
Secondary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1.5 mg once weekly · 36 weeksAs given in this study (human).
Measurements
HbA1c target attainment
57%
1.5 mg efficacy estimand
Source sentences
Summary
% of patients achieving HbA1c <7% (1.5 mg, 57%; 3.0 mg, 65% [p=0.006]; 4.5 mg, 71% [p<0.001])
3 context sentences(design, population, supporting numbers)
Summary · context
The primary objective was to demonstrate superiority of once-weekly DU 3 mg and/or 4.5 mg to DU 1.5 mg for A1C change from baseline (BL) at 36 weeks (wks) in patients (pts) with inadequately controlled T2D on metformin therapy.
Summary · context
Patients were randomized (1:1:1) to once-weekly DU 1.5 mg (n=612), DU 3 mg (n=616), and DU 4.5 mg (n=614).
Summary · context
Two estimands were defined for efficacy analyses: an efficacy estimand (data on-treatment without rescue medication) and a treatment-regimen estimand (all data regardless of adherence or initiation of rescue).
Report a problemFND-9902526702
08HumanRandomized controlled trialEfficacy outcome
In patients with T2D, dulaglutide 1.5 mg reduced weight by 3.1 kg under the efficacy estimand.
In plain wordsIn patients with T2D, weight decreased from baseline by 3.1 kg with dulaglutide 1.5 mg during treatment without rescue medication.
Peptide
Dulaglutide (Trulicity)
Outcome
DecreaseBody weight change, efficacy estimand
Study
n: not reported in source
Comparator
Baseline
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Studied dose
1.5 mg once weekly · 36 weeksAs given in this study (human).
Measurements
Weight reduction
3.1 kg
1.5 mg efficacy estimand
Source sentences
Summary
and BW change from BL (1.5 mg, 3.1 kg; 3 mg, 4.0 kg [p=0.001]; 4.5 mg, 4.7 kg [p<0.001]).
3 context sentences(design, population, supporting numbers)
Summary · context
The primary objective was to demonstrate superiority of once-weekly DU 3 mg and/or 4.5 mg to DU 1.5 mg for A1C change from baseline (BL) at 36 weeks (wks) in patients (pts) with inadequately controlled T2D on metformin therapy.
Summary · context
Patients were randomized (1:1:1) to once-weekly DU 1.5 mg (n=612), DU 3 mg (n=616), and DU 4.5 mg (n=614).
Summary · context
Two estimands were defined for efficacy analyses: an efficacy estimand (data on-treatment without rescue medication) and a treatment-regimen estimand (all data regardless of adherence or initiation of rescue).
Report a problemFND-9902526703
09HumanRandomized controlled trialEfficacy outcome
In patients with T2D, 50% reached A1C below 7% with dulaglutide 1.5 mg under the treatment-regimen estimand.
In plain wordsIn patients with T2D, 50% reached the A1C target with dulaglutide 1.5 mg when all treatment data were included.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableA1C below 7%, treatment-regimen estimand
Study
n: not reported in source
Analysis
Secondary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1.5 mg once weekly · 36 weeksAs given in this study (human).
Measurements
A1C target attainment
50%
1.5 mg treatment-regimen estimand
Source sentences
Summary
Using the treatment-regimen estimand, more patients achieved A1C <7% with higher DU doses (1.5 mg, 50%; 3 mg, 56%; 4.5 mg, 62%)
3 context sentences(design, population, supporting numbers)
Summary · context
The primary objective was to demonstrate superiority of once-weekly DU 3 mg and/or 4.5 mg to DU 1.5 mg for A1C change from baseline (BL) at 36 weeks (wks) in patients (pts) with inadequately controlled T2D on metformin therapy.
Summary · context
Patients were randomized (1:1:1) to once-weekly DU 1.5 mg (n=612), DU 3 mg (n=616), and DU 4.5 mg (n=614).
Summary · context
Two estimands were defined for efficacy analyses: an efficacy estimand (data on-treatment without rescue medication) and a treatment-regimen estimand (all data regardless of adherence or initiation of rescue).
Report a problemFND-9902526705
10HumanRandomized controlled trialEfficacy outcome
In patients with T2D, dulaglutide 1.5 mg reduced weight by 3.0 kg under the treatment-regimen estimand.
In plain wordsIn patients with T2D, weight decreased from baseline by 3.0 kg with dulaglutide 1.5 mg when all treatment data were included.
Peptide
Dulaglutide (Trulicity)
Outcome
DecreaseBody weight change, treatment-regimen estimand
Study
n: not reported in source
Comparator
Baseline
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Studied dose
1.5 mg once weekly · 36 weeksAs given in this study (human).
Measurements
Weight reduction
3 kg
1.5 mg treatment-regimen estimand
Source sentences
Summary
and results for BW change were similar to the efficacy estimand (1.5 mg, 3.0 kg; 3 mg, 3.8 kg; 4.5 mg, 4.6 kg), but the approach for type I error control did not permit formal statistical comparisons of these secondary objectives using this estimand.
3 context sentences(design, population, supporting numbers)
Summary · context
The primary objective was to demonstrate superiority of once-weekly DU 3 mg and/or 4.5 mg to DU 1.5 mg for A1C change from baseline (BL) at 36 weeks (wks) in patients (pts) with inadequately controlled T2D on metformin therapy.
Summary · context
Patients were randomized (1:1:1) to once-weekly DU 1.5 mg (n=612), DU 3 mg (n=616), and DU 4.5 mg (n=614).
Summary · context
Two estimands were defined for efficacy analyses: an efficacy estimand (data on-treatment without rescue medication) and a treatment-regimen estimand (all data regardless of adherence or initiation of rescue).
Report a problemFND-9902526706
11HumanRandomized controlled trialEfficacy outcome
In patients with T2D, more reached HbA1c below 7% with dulaglutide 3 mg than 1.5 mg under the efficacy estimand.
In plain wordsIn patients with T2D, more reached the HbA1c target with dulaglutide 3 mg than 1.5 mg during treatment without rescue medication.
Peptide
Dulaglutide (Trulicity)
Outcome
IncreaseHbA1c below 7%, efficacy estimand
Study
n: not reported in source
Comparator
Dulaglutide 1.5 mg
Analysis
Secondary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
3 mg once weekly · 36 weeksAs given in this study (human).
Measurements
HbA1c target attainment
65%
3.0 mg efficacy estimand
HbA1c target attainment
57%
1.5 mg efficacy estimand
Source sentences
Summary
% of patients achieving HbA1c <7% (1.5 mg, 57%; 3.0 mg, 65% [p=0.006]; 4.5 mg, 71% [p<0.001])
3 context sentences(design, population, supporting numbers)
Summary · context
The primary objective was to demonstrate superiority of once-weekly DU 3 mg and/or 4.5 mg to DU 1.5 mg for A1C change from baseline (BL) at 36 weeks (wks) in patients (pts) with inadequately controlled T2D on metformin therapy.
Summary · context
Patients were randomized (1:1:1) to once-weekly DU 1.5 mg (n=612), DU 3 mg (n=616), and DU 4.5 mg (n=614).
Summary · context
Two estimands were defined for efficacy analyses: an efficacy estimand (data on-treatment without rescue medication) and a treatment-regimen estimand (all data regardless of adherence or initiation of rescue).
Report a problemFND-9902526709
12HumanRandomized controlled trialEfficacy outcome
In patients with T2D, more reached HbA1c below 7% with dulaglutide 4.5 mg than 1.5 mg under the efficacy estimand.
In plain wordsIn patients with T2D, more reached the HbA1c target with dulaglutide 4.5 mg than 1.5 mg during treatment without rescue medication.
Peptide
Dulaglutide (Trulicity)
Outcome
IncreaseHbA1c below 7%, efficacy estimand
Study
n: not reported in source
Comparator
Dulaglutide 1.5 mg
Analysis
Secondary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
4.5 mg once weekly · 36 weeksAs given in this study (human).
Measurements
HbA1c target attainment
71%
4.5 mg efficacy estimand
HbA1c target attainment
57%
1.5 mg efficacy estimand
Source sentences
Summary
% of patients achieving HbA1c <7% (1.5 mg, 57%; 3.0 mg, 65% [p=0.006]; 4.5 mg, 71% [p<0.001])
3 context sentences(design, population, supporting numbers)
Summary · context
The primary objective was to demonstrate superiority of once-weekly DU 3 mg and/or 4.5 mg to DU 1.5 mg for A1C change from baseline (BL) at 36 weeks (wks) in patients (pts) with inadequately controlled T2D on metformin therapy.
Summary · context
Patients were randomized (1:1:1) to once-weekly DU 1.5 mg (n=612), DU 3 mg (n=616), and DU 4.5 mg (n=614).
Summary · context
Two estimands were defined for efficacy analyses: an efficacy estimand (data on-treatment without rescue medication) and a treatment-regimen estimand (all data regardless of adherence or initiation of rescue).
Report a problemFND-9902526710
13HumanRandomized controlled trialEfficacy outcome
In patients with T2D, dulaglutide 3 mg reduced weight more than 1.5 mg under the efficacy estimand.
In plain wordsIn patients with T2D, dulaglutide 3 mg reduced weight more than 1.5 mg during treatment without rescue medication.
Peptide
Dulaglutide (Trulicity)
Outcome
DecreaseBody weight change, efficacy estimand
Study
n: not reported in source
Comparator
Dulaglutide 1.5 mg
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Studied dose
3 mg once weekly · 36 weeksAs given in this study (human).
Measurements
Weight reduction
4 kg
3 mg efficacy estimand
Weight reduction
3.1 kg
1.5 mg efficacy estimand
Source sentences
Summary
and BW change from BL (1.5 mg, 3.1 kg; 3 mg, 4.0 kg [p=0.001]; 4.5 mg, 4.7 kg [p<0.001]).
3 context sentences(design, population, supporting numbers)
Summary · context
The primary objective was to demonstrate superiority of once-weekly DU 3 mg and/or 4.5 mg to DU 1.5 mg for A1C change from baseline (BL) at 36 weeks (wks) in patients (pts) with inadequately controlled T2D on metformin therapy.
Summary · context
Patients were randomized (1:1:1) to once-weekly DU 1.5 mg (n=612), DU 3 mg (n=616), and DU 4.5 mg (n=614).
Summary · context
Two estimands were defined for efficacy analyses: an efficacy estimand (data on-treatment without rescue medication) and a treatment-regimen estimand (all data regardless of adherence or initiation of rescue).
Report a problemFND-9902526711
14HumanRandomized controlled trialEfficacy outcome
In patients with T2D, dulaglutide 4.5 mg reduced weight more than 1.5 mg under the efficacy estimand.
In plain wordsIn patients with T2D, dulaglutide 4.5 mg reduced weight more than 1.5 mg during treatment without rescue medication.
Peptide
Dulaglutide (Trulicity)
Outcome
DecreaseBody weight change, efficacy estimand
Study
n: not reported in source
Comparator
Dulaglutide 1.5 mg
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Studied dose
4.5 mg once weekly · 36 weeksAs given in this study (human).
Measurements
Weight reduction
4.7 kg
4.5 mg efficacy estimand
Weight reduction
3.1 kg
1.5 mg efficacy estimand
Source sentences
Summary
and BW change from BL (1.5 mg, 3.1 kg; 3 mg, 4.0 kg [p=0.001]; 4.5 mg, 4.7 kg [p<0.001]).
3 context sentences(design, population, supporting numbers)
Summary · context
The primary objective was to demonstrate superiority of once-weekly DU 3 mg and/or 4.5 mg to DU 1.5 mg for A1C change from baseline (BL) at 36 weeks (wks) in patients (pts) with inadequately controlled T2D on metformin therapy.
Summary · context
Patients were randomized (1:1:1) to once-weekly DU 1.5 mg (n=612), DU 3 mg (n=616), and DU 4.5 mg (n=614).
Summary · context
Two estimands were defined for efficacy analyses: an efficacy estimand (data on-treatment without rescue medication) and a treatment-regimen estimand (all data regardless of adherence or initiation of rescue).
Report a problemFND-9902526712
15HumanRandomized controlled trialEfficacy outcome
In patients with T2D, A1C target attainment was descriptively higher with dulaglutide 3 mg than 1.5 mg under the treatment-regimen estimand.
In plain wordsIn patients with T2D, more reached the A1C target with dulaglutide 3 mg than 1.5 mg, without a formal statistical comparison.
Peptide
Dulaglutide (Trulicity)
Outcome
IncreaseA1C below 7%, treatment-regimen estimand
Study
n: not reported in source
Comparator
Dulaglutide 1.5 mg
Analysis
Secondary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
3 mg once weekly · 36 weeksAs given in this study (human).
Measurements
A1C target attainment
56%
3 mg treatment-regimen estimand
A1C target attainment
50%
1.5 mg treatment-regimen estimand
Source sentences
Summary
Using the treatment-regimen estimand, more patients achieved A1C <7% with higher DU doses (1.5 mg, 50%; 3 mg, 56%; 4.5 mg, 62%)
4 context sentences(design, population, supporting numbers)
Summary · context
but the approach for type I error control did not permit formal statistical comparisons of these secondary objectives using this estimand.
Summary · context
The primary objective was to demonstrate superiority of once-weekly DU 3 mg and/or 4.5 mg to DU 1.5 mg for A1C change from baseline (BL) at 36 weeks (wks) in patients (pts) with inadequately controlled T2D on metformin therapy.
Summary · context
Patients were randomized (1:1:1) to once-weekly DU 1.5 mg (n=612), DU 3 mg (n=616), and DU 4.5 mg (n=614).
Summary · context
Two estimands were defined for efficacy analyses: an efficacy estimand (data on-treatment without rescue medication) and a treatment-regimen estimand (all data regardless of adherence or initiation of rescue).
Report a problemFND-9902526715
16HumanRandomized controlled trialEfficacy outcome
In patients with T2D, A1C target attainment was descriptively higher with dulaglutide 4.5 mg than 1.5 mg under the treatment-regimen estimand.
In plain wordsIn patients with T2D, more reached the A1C target with dulaglutide 4.5 mg than 1.5 mg, without a formal statistical comparison.
Peptide
Dulaglutide (Trulicity)
Outcome
IncreaseA1C below 7%, treatment-regimen estimand
Study
n: not reported in source
Comparator
Dulaglutide 1.5 mg
Analysis
Secondary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
4.5 mg once weekly · 36 weeksAs given in this study (human).
Measurements
A1C target attainment
62%
4.5 mg treatment-regimen estimand
A1C target attainment
50%
1.5 mg treatment-regimen estimand
Source sentences
Summary
Using the treatment-regimen estimand, more patients achieved A1C <7% with higher DU doses (1.5 mg, 50%; 3 mg, 56%; 4.5 mg, 62%)
4 context sentences(design, population, supporting numbers)
Summary · context
but the approach for type I error control did not permit formal statistical comparisons of these secondary objectives using this estimand.
Summary · context
The primary objective was to demonstrate superiority of once-weekly DU 3 mg and/or 4.5 mg to DU 1.5 mg for A1C change from baseline (BL) at 36 weeks (wks) in patients (pts) with inadequately controlled T2D on metformin therapy.
Summary · context
Patients were randomized (1:1:1) to once-weekly DU 1.5 mg (n=612), DU 3 mg (n=616), and DU 4.5 mg (n=614).
Summary · context
Two estimands were defined for efficacy analyses: an efficacy estimand (data on-treatment without rescue medication) and a treatment-regimen estimand (all data regardless of adherence or initiation of rescue).
Report a problemFND-9902526716
17HumanRandomized controlled trialEfficacy outcome
In patients with T2D, dulaglutide 3 mg produced descriptively greater weight reduction than 1.5 mg under the treatment-regimen estimand.
In plain wordsIn patients with T2D, dulaglutide 3 mg reduced weight more than 1.5 mg, without a formal statistical comparison.
Peptide
Dulaglutide (Trulicity)
Outcome
DecreaseBody weight change, treatment-regimen estimand
Study
n: not reported in source
Comparator
Dulaglutide 1.5 mg
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Studied dose
3 mg once weekly · 36 weeksAs given in this study (human).
Measurements
Weight reduction
3.8 kg
3 mg treatment-regimen estimand
Weight reduction
3 kg
1.5 mg treatment-regimen estimand
Source sentences
Summary
and results for BW change were similar to the efficacy estimand (1.5 mg, 3.0 kg; 3 mg, 3.8 kg; 4.5 mg, 4.6 kg), but the approach for type I error control did not permit formal statistical comparisons of these secondary objectives using this estimand.
3 context sentences(design, population, supporting numbers)
Summary · context
The primary objective was to demonstrate superiority of once-weekly DU 3 mg and/or 4.5 mg to DU 1.5 mg for A1C change from baseline (BL) at 36 weeks (wks) in patients (pts) with inadequately controlled T2D on metformin therapy.
Summary · context
Patients were randomized (1:1:1) to once-weekly DU 1.5 mg (n=612), DU 3 mg (n=616), and DU 4.5 mg (n=614).
Summary · context
Two estimands were defined for efficacy analyses: an efficacy estimand (data on-treatment without rescue medication) and a treatment-regimen estimand (all data regardless of adherence or initiation of rescue).
Report a problemFND-9902526717
18HumanRandomized controlled trialEfficacy outcome
In patients with T2D, dulaglutide 4.5 mg produced descriptively greater weight reduction than 1.5 mg under the treatment-regimen estimand.
In plain wordsIn patients with T2D, dulaglutide 4.5 mg reduced weight more than 1.5 mg, without a formal statistical comparison.
Peptide
Dulaglutide (Trulicity)
Outcome
DecreaseBody weight change, treatment-regimen estimand
Study
n: not reported in source
Comparator
Dulaglutide 1.5 mg
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Studied dose
4.5 mg once weekly · 36 weeksAs given in this study (human).
Measurements
Weight reduction
4.6 kg
4.5 mg treatment-regimen estimand
Weight reduction
3 kg
1.5 mg treatment-regimen estimand
Source sentences
Summary
and results for BW change were similar to the efficacy estimand (1.5 mg, 3.0 kg; 3 mg, 3.8 kg; 4.5 mg, 4.6 kg), but the approach for type I error control did not permit formal statistical comparisons of these secondary objectives using this estimand.
3 context sentences(design, population, supporting numbers)
Summary · context
The primary objective was to demonstrate superiority of once-weekly DU 3 mg and/or 4.5 mg to DU 1.5 mg for A1C change from baseline (BL) at 36 weeks (wks) in patients (pts) with inadequately controlled T2D on metformin therapy.
Summary · context
Patients were randomized (1:1:1) to once-weekly DU 1.5 mg (n=612), DU 3 mg (n=616), and DU 4.5 mg (n=614).
Summary · context
Two estimands were defined for efficacy analyses: an efficacy estimand (data on-treatment without rescue medication) and a treatment-regimen estimand (all data regardless of adherence or initiation of rescue).
Report a problemFND-9902526718
19HumanRandomized controlled trialSafety outcome
In patients with T2D, adverse-event discontinuation was similar with dulaglutide 3 mg and 1.5 mg.
In plain wordsIn patients with T2D, adverse-event discontinuation was similar with dulaglutide 3 mg and 1.5 mg.
Peptide
Dulaglutide (Trulicity)
Outcome
No significant changeDiscontinuation due to adverse events
Study
n = 1,228
Comparator
Dulaglutide 1.5 mg
Outcome group
Adverse events · Whole body
Studied dose
3 mg once weekly · 36 weeksAs given in this study (human).
Measurements
Discontinuation
5.5%
DU 3 mg
Discontinuation
4.2%
DU 1.5 mg
Source sentences
Summary
Treatment discontinuation due to adverse events through 36 wks was low and similar across dose groups (DU 1.5 mg, 4.2%; DU 3 mg, 5.5%; DU 4.5 mg, 5.0%).
3 context sentences(design, population, supporting numbers)
Summary · context
The primary objective was to demonstrate superiority of once-weekly DU 3 mg and/or 4.5 mg to DU 1.5 mg for A1C change from baseline (BL) at 36 weeks (wks) in patients (pts) with inadequately controlled T2D on metformin therapy.
Summary · context
Patients were randomized (1:1:1) to once-weekly DU 1.5 mg (n=612), DU 3 mg (n=616), and DU 4.5 mg (n=614).
Summary · context
Two estimands were defined for efficacy analyses: an efficacy estimand (data on-treatment without rescue medication) and a treatment-regimen estimand (all data regardless of adherence or initiation of rescue).
Report a problemFND-9902526730
20HumanRandomized controlled trialSafety outcome
In patients with T2D, adverse-event discontinuation was similar with dulaglutide 4.5 mg and 1.5 mg.
In plain wordsIn patients with T2D, adverse-event discontinuation was similar with dulaglutide 4.5 mg and 1.5 mg.
Peptide
Dulaglutide (Trulicity)
Outcome
No significant changeDiscontinuation due to adverse events
Study
n = 1,226
Comparator
Dulaglutide 1.5 mg
Outcome group
Adverse events · Whole body
Studied dose
4.5 mg once weekly · 36 weeksAs given in this study (human).
Measurements
Discontinuation
5%
DU 4.5 mg
Discontinuation
4.2%
DU 1.5 mg
Source sentences
Summary
Treatment discontinuation due to adverse events through 36 wks was low and similar across dose groups (DU 1.5 mg, 4.2%; DU 3 mg, 5.5%; DU 4.5 mg, 5.0%).
3 context sentences(design, population, supporting numbers)
Summary · context
The primary objective was to demonstrate superiority of once-weekly DU 3 mg and/or 4.5 mg to DU 1.5 mg for A1C change from baseline (BL) at 36 weeks (wks) in patients (pts) with inadequately controlled T2D on metformin therapy.
Summary · context
Patients were randomized (1:1:1) to once-weekly DU 1.5 mg (n=612), DU 3 mg (n=616), and DU 4.5 mg (n=614).
Summary · context
Two estimands were defined for efficacy analyses: an efficacy estimand (data on-treatment without rescue medication) and a treatment-regimen estimand (all data regardless of adherence or initiation of rescue).
Report a problemFND-9902526731
21HumanRandomized controlled trialSafety outcome
In patients with T2D, nausea occurred in 15.6% with dulaglutide 3 mg.
In plain wordsIn patients with T2D, nausea occurred in 15.6% with dulaglutide 3 mg.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableNausea
Study
n = 616
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
3 mg once weekly · 36 weeksAs given in this study (human).
Measurements
Nausea
15.6%
DU 3 mg
Source sentences
Summary
The most commonly reported adverse events were nausea (DU 1.5 mg, 13.4%; DU 3 mg, 15.6%; DU 4.5 mg, 16.4%),
3 context sentences(design, population, supporting numbers)
Summary · context
The primary objective was to demonstrate superiority of once-weekly DU 3 mg and/or 4.5 mg to DU 1.5 mg for A1C change from baseline (BL) at 36 weeks (wks) in patients (pts) with inadequately controlled T2D on metformin therapy.
Summary · context
Patients were randomized (1:1:1) to once-weekly DU 1.5 mg (n=612), DU 3 mg (n=616), and DU 4.5 mg (n=614).
Summary · context
Two estimands were defined for efficacy analyses: an efficacy estimand (data on-treatment without rescue medication) and a treatment-regimen estimand (all data regardless of adherence or initiation of rescue).
Report a problemFND-9902526721
22HumanRandomized controlled trialSafety outcome
In patients with T2D, vomiting occurred in 8.3% with dulaglutide 3 mg.
In plain wordsIn patients with T2D, vomiting occurred in 8.3% with dulaglutide 3 mg.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableVomiting
Study
n = 616
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
3 mg once weekly · 36 weeksAs given in this study (human).
Measurements
Vomiting
8.3%
DU 3 mg
Source sentences
Summary
vomiting (DU 1.5 mg, 5.6%; DU 3 mg, 8.3%; DU 4.5 mg, 9.3%),
3 context sentences(design, population, supporting numbers)
Summary · context
The primary objective was to demonstrate superiority of once-weekly DU 3 mg and/or 4.5 mg to DU 1.5 mg for A1C change from baseline (BL) at 36 weeks (wks) in patients (pts) with inadequately controlled T2D on metformin therapy.
Summary · context
Patients were randomized (1:1:1) to once-weekly DU 1.5 mg (n=612), DU 3 mg (n=616), and DU 4.5 mg (n=614).
Summary · context
Two estimands were defined for efficacy analyses: an efficacy estimand (data on-treatment without rescue medication) and a treatment-regimen estimand (all data regardless of adherence or initiation of rescue).
Report a problemFND-9902526724
23HumanRandomized controlled trialSafety outcome
In patients with T2D, diarrhea occurred in 11.4% with dulaglutide 3 mg.
In plain wordsIn patients with T2D, diarrhea occurred in 11.4% with dulaglutide 3 mg.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableDiarrhea
Study
n = 616
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
3 mg once weekly · 36 weeksAs given in this study (human).
Measurements
Diarrhea
11.4%
DU 3 mg
Source sentences
Summary
and diarrhea (DU 1.5 mg, 7.0%; DU 3 mg, 11.4%; DU 4.5 mg, 10.7%).
3 context sentences(design, population, supporting numbers)
Summary · context
The primary objective was to demonstrate superiority of once-weekly DU 3 mg and/or 4.5 mg to DU 1.5 mg for A1C change from baseline (BL) at 36 weeks (wks) in patients (pts) with inadequately controlled T2D on metformin therapy.
Summary · context
Patients were randomized (1:1:1) to once-weekly DU 1.5 mg (n=612), DU 3 mg (n=616), and DU 4.5 mg (n=614).
Summary · context
Two estimands were defined for efficacy analyses: an efficacy estimand (data on-treatment without rescue medication) and a treatment-regimen estimand (all data regardless of adherence or initiation of rescue).
Report a problemFND-9902526727
24HumanRandomized controlled trialSafety outcome
In patients with T2D, nausea occurred in 16.4% with dulaglutide 4.5 mg.
In plain wordsIn patients with T2D, nausea occurred in 16.4% with dulaglutide 4.5 mg.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableNausea
Study
n = 614
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
4.5 mg once weekly · 36 weeksAs given in this study (human).
Measurements
Nausea
16.4%
DU 4.5 mg
Source sentences
Summary
The most commonly reported adverse events were nausea (DU 1.5 mg, 13.4%; DU 3 mg, 15.6%; DU 4.5 mg, 16.4%),
3 context sentences(design, population, supporting numbers)
Summary · context
The primary objective was to demonstrate superiority of once-weekly DU 3 mg and/or 4.5 mg to DU 1.5 mg for A1C change from baseline (BL) at 36 weeks (wks) in patients (pts) with inadequately controlled T2D on metformin therapy.
Summary · context
Patients were randomized (1:1:1) to once-weekly DU 1.5 mg (n=612), DU 3 mg (n=616), and DU 4.5 mg (n=614).
Summary · context
Two estimands were defined for efficacy analyses: an efficacy estimand (data on-treatment without rescue medication) and a treatment-regimen estimand (all data regardless of adherence or initiation of rescue).
Report a problemFND-9902526722
25HumanRandomized controlled trialSafety outcome
In patients with T2D, vomiting occurred in 9.3% with dulaglutide 4.5 mg.
In plain wordsIn patients with T2D, vomiting occurred in 9.3% with dulaglutide 4.5 mg.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableVomiting
Study
n = 614
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
4.5 mg once weekly · 36 weeksAs given in this study (human).
Measurements
Vomiting
9.3%
DU 4.5 mg
Source sentences
Summary
vomiting (DU 1.5 mg, 5.6%; DU 3 mg, 8.3%; DU 4.5 mg, 9.3%),
3 context sentences(design, population, supporting numbers)
Summary · context
The primary objective was to demonstrate superiority of once-weekly DU 3 mg and/or 4.5 mg to DU 1.5 mg for A1C change from baseline (BL) at 36 weeks (wks) in patients (pts) with inadequately controlled T2D on metformin therapy.
Summary · context
Patients were randomized (1:1:1) to once-weekly DU 1.5 mg (n=612), DU 3 mg (n=616), and DU 4.5 mg (n=614).
Summary · context
Two estimands were defined for efficacy analyses: an efficacy estimand (data on-treatment without rescue medication) and a treatment-regimen estimand (all data regardless of adherence or initiation of rescue).
Report a problemFND-9902526725
26HumanRandomized controlled trialSafety outcome
In patients with T2D, diarrhea occurred in 10.7% with dulaglutide 4.5 mg.
In plain wordsIn patients with T2D, diarrhea occurred in 10.7% with dulaglutide 4.5 mg.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableDiarrhea
Study
n = 614
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
4.5 mg once weekly · 36 weeksAs given in this study (human).
Measurements
Diarrhea
10.7%
DU 4.5 mg
Source sentences
Summary
and diarrhea (DU 1.5 mg, 7.0%; DU 3 mg, 11.4%; DU 4.5 mg, 10.7%).
3 context sentences(design, population, supporting numbers)
Summary · context
The primary objective was to demonstrate superiority of once-weekly DU 3 mg and/or 4.5 mg to DU 1.5 mg for A1C change from baseline (BL) at 36 weeks (wks) in patients (pts) with inadequately controlled T2D on metformin therapy.
Summary · context
Patients were randomized (1:1:1) to once-weekly DU 1.5 mg (n=612), DU 3 mg (n=616), and DU 4.5 mg (n=614).
Summary · context
Two estimands were defined for efficacy analyses: an efficacy estimand (data on-treatment without rescue medication) and a treatment-regimen estimand (all data regardless of adherence or initiation of rescue).
Report a problemFND-9902526728
27HumanRandomized controlled trialSafety outcome
In patients with T2D, nausea occurred in 13.4% with dulaglutide 1.5 mg.
In plain wordsIn patients with T2D, nausea occurred in 13.4% with dulaglutide 1.5 mg.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableNausea
Study
n = 612
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
1.5 mg once weekly · 36 weeksAs given in this study (human).
Measurements
Nausea
13.4%
DU 1.5 mg
Source sentences
Summary
The most commonly reported adverse events were nausea (DU 1.5 mg, 13.4%; DU 3 mg, 15.6%; DU 4.5 mg, 16.4%),
3 context sentences(design, population, supporting numbers)
Summary · context
The primary objective was to demonstrate superiority of once-weekly DU 3 mg and/or 4.5 mg to DU 1.5 mg for A1C change from baseline (BL) at 36 weeks (wks) in patients (pts) with inadequately controlled T2D on metformin therapy.
Summary · context
Patients were randomized (1:1:1) to once-weekly DU 1.5 mg (n=612), DU 3 mg (n=616), and DU 4.5 mg (n=614).
Summary · context
Two estimands were defined for efficacy analyses: an efficacy estimand (data on-treatment without rescue medication) and a treatment-regimen estimand (all data regardless of adherence or initiation of rescue).
Report a problemFND-9902526720
28HumanRandomized controlled trialSafety outcome
In patients with T2D, vomiting occurred in 5.6% with dulaglutide 1.5 mg.
In plain wordsIn patients with T2D, vomiting occurred in 5.6% with dulaglutide 1.5 mg.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableVomiting
Study
n = 612
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
1.5 mg once weekly · 36 weeksAs given in this study (human).
Measurements
Vomiting
5.6%
DU 1.5 mg
Source sentences
Summary
vomiting (DU 1.5 mg, 5.6%; DU 3 mg, 8.3%; DU 4.5 mg, 9.3%),
3 context sentences(design, population, supporting numbers)
Summary · context
The primary objective was to demonstrate superiority of once-weekly DU 3 mg and/or 4.5 mg to DU 1.5 mg for A1C change from baseline (BL) at 36 weeks (wks) in patients (pts) with inadequately controlled T2D on metformin therapy.
Summary · context
Patients were randomized (1:1:1) to once-weekly DU 1.5 mg (n=612), DU 3 mg (n=616), and DU 4.5 mg (n=614).
Summary · context
Two estimands were defined for efficacy analyses: an efficacy estimand (data on-treatment without rescue medication) and a treatment-regimen estimand (all data regardless of adherence or initiation of rescue).
Report a problemFND-9902526723
29HumanRandomized controlled trialSafety outcome
In patients with T2D, diarrhea occurred in 7.0% with dulaglutide 1.5 mg.
In plain wordsIn patients with T2D, diarrhea occurred in 7.0% with dulaglutide 1.5 mg.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableDiarrhea
Study
n = 612
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
1.5 mg once weekly · 36 weeksAs given in this study (human).
Measurements
Diarrhea
7%
DU 1.5 mg
Source sentences
Summary
and diarrhea (DU 1.5 mg, 7.0%; DU 3 mg, 11.4%; DU 4.5 mg, 10.7%).
3 context sentences(design, population, supporting numbers)
Summary · context
The primary objective was to demonstrate superiority of once-weekly DU 3 mg and/or 4.5 mg to DU 1.5 mg for A1C change from baseline (BL) at 36 weeks (wks) in patients (pts) with inadequately controlled T2D on metformin therapy.
Summary · context
Patients were randomized (1:1:1) to once-weekly DU 1.5 mg (n=612), DU 3 mg (n=616), and DU 4.5 mg (n=614).
Summary · context
Two estimands were defined for efficacy analyses: an efficacy estimand (data on-treatment without rescue medication) and a treatment-regimen estimand (all data regardless of adherence or initiation of rescue).
Report a problemFND-9902526726
30HumanRandomized controlled trialSafety outcome
In patients with T2D, 4.2% discontinued dulaglutide 1.5 mg because of adverse events.
In plain wordsIn patients with T2D, 4.2% discontinued dulaglutide 1.5 mg because of adverse events.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableDiscontinuation due to adverse events
Study
n = 612
Outcome group
Adverse events · Whole body
Studied dose
1.5 mg once weekly · 36 weeksAs given in this study (human).
Measurements
Discontinuation
4.2%
DU 1.5 mg
Source sentences
Summary
Treatment discontinuation due to adverse events through 36 wks was low and similar across dose groups (DU 1.5 mg, 4.2%; DU 3 mg, 5.5%; DU 4.5 mg, 5.0%).
3 context sentences(design, population, supporting numbers)
Summary · context
The primary objective was to demonstrate superiority of once-weekly DU 3 mg and/or 4.5 mg to DU 1.5 mg for A1C change from baseline (BL) at 36 weeks (wks) in patients (pts) with inadequately controlled T2D on metformin therapy.
Summary · context
Patients were randomized (1:1:1) to once-weekly DU 1.5 mg (n=612), DU 3 mg (n=616), and DU 4.5 mg (n=614).
Summary · context
Two estimands were defined for efficacy analyses: an efficacy estimand (data on-treatment without rescue medication) and a treatment-regimen estimand (all data regardless of adherence or initiation of rescue).
Report a problemFND-9902526729
31HumanRandomized controlled trialSafety outcome
In patients with T2D, higher dulaglutide doses had a safety profile consistent with 1.5 mg.
In plain wordsIn patients with T2D, higher dulaglutide doses had a safety profile consistent with 1.5 mg.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableOverall safety profile
Study
n: not reported in source
Comparator
Dulaglutide 1.5 mg
Outcome group
Adverse events · Whole body
Studied dose
3 mg and 4.5 mg once weekly · 36 weeksAs given in this study (human).
Source sentences
Summary
The safety profile for the higher DU doses was consistent with that known for 1.5 mg.
3 context sentences(design, population, supporting numbers)
Summary · context
The primary objective was to demonstrate superiority of once-weekly DU 3 mg and/or 4.5 mg to DU 1.5 mg for A1C change from baseline (BL) at 36 weeks (wks) in patients (pts) with inadequately controlled T2D on metformin therapy.
Summary · context
Patients were randomized (1:1:1) to once-weekly DU 1.5 mg (n=612), DU 3 mg (n=616), and DU 4.5 mg (n=614).
Summary · context
Two estimands were defined for efficacy analyses: an efficacy estimand (data on-treatment without rescue medication) and a treatment-regimen estimand (all data regardless of adherence or initiation of rescue).
Report a problemFND-9902526719

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
22 Oct 2026, 02:26 UTC
Study results updated
Version 1
21 Oct 2026, 18:59 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

Publication types

Abstract

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