Efficacy and Safety of Dulaglutide 3.0 mg and 4.5 mg Versus Dulaglutide 1.5 mg in Metformin-Treated Patients With Type 2 Diabetes in a Randomized Controlled Trial (AWARD-11).

Frias JP, Bonora E, Nevarez Ruiz L, Li YG, Yu Z, Milicevic Z, Malik R, Bethel MA, Cox DA

Diabetes care4 Jan 2021Cited by 148 (Europe PMC)

PMID33397768PMCIDPMC7896253DOI10.2337/dc20-1473PepBankPUB-33397768

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study12

12 results from studies that gave the peptide. 12 results from people.

01HumanRandomized controlled trialEfficacy outcome
In metformin-treated T2D, dulaglutide 4.5 mg reduced HbA1c more than 1.5 mg under the treatment-regimen estimand.
In plain wordsIn patients taking metformin, higher-dose dulaglutide lowered blood sugar more than the lower dose.
Peptide
Dulaglutide (Trulicity)
Outcome
DecreaseHbA1c treatment-regimen estimand
Study
n: not reported in source
Comparator
Dulaglutide 1.5 mg weekly
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
4.5 mg weekly · 36 weeksAs given in this study (human).
Measurements
HbA1c change
−1.77%
4.5 mg treatment-regimen estimand
HbA1c change
−1.54%
1.5 mg treatment-regimen estimand
ETD
−0.24%
4.5 versus 1.5 mg
Source sentences
Summary
At 36 weeks, dulaglutide 4.5 mg provided superior HbA_1c reductions compared with 1.5 mg (treatment-regimen estimand: -1.77 vs. -1.54% [-19.4 vs. -16.8 mmol/mol], estimated treatment difference [ETD] -0.24% (-2.6 mmol/mol), P < 0.001;
2 context sentences(design, population, supporting numbers)
Summary · context
To compare efficacy and safety of dulaglutide at doses of 3.0 and 4.5 mg versus 1.5 mg in patients with type 2 diabetes inadequately controlled with metformin.
Summary · context
Patients were randomly assigned to once-weekly dulaglutide 1.5 mg, 3.0 mg, or 4.5 mg for 52 weeks.
Report a problemFND-3339776801
02HumanRandomized controlled trialEfficacy outcome
In metformin-treated T2D, dulaglutide 4.5 mg reduced HbA1c more than 1.5 mg under the efficacy estimand.
In plain wordsIn patients taking metformin, higher-dose dulaglutide lowered blood sugar more than the lower dose during treatment.
Peptide
Dulaglutide (Trulicity)
Outcome
DecreaseHbA1c efficacy estimand
Study
n: not reported in source
Comparator
Dulaglutide 1.5 mg weekly
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
4.5 mg weekly · 36 weeksAs given in this study (human).
Measurements
HbA1c change
−1.87%
4.5 mg efficacy estimand
HbA1c change
−1.53%
1.5 mg efficacy estimand
ETD
−0.34%
4.5 versus 1.5 mg
Source sentences
Summary
efficacy estimand: -1.87 vs. -1.53% [-20.4 vs. -16.7 mmol/mol], ETD -0.34% (-3.7 mmol/mol), P < 0.001).
2 context sentences(design, population, supporting numbers)
Summary · context
To compare efficacy and safety of dulaglutide at doses of 3.0 and 4.5 mg versus 1.5 mg in patients with type 2 diabetes inadequately controlled with metformin.
Summary · context
Patients were randomly assigned to once-weekly dulaglutide 1.5 mg, 3.0 mg, or 4.5 mg for 52 weeks.
Report a problemFND-3339776802
03HumanRandomized controlled trialEfficacy outcome
In metformin-treated T2D, dulaglutide 3.0 mg reduced HbA1c more than 1.5 mg under the efficacy estimand.
In plain wordsIn patients taking metformin, the middle dulaglutide dose lowered blood sugar more than the lower dose during treatment.
Peptide
Dulaglutide (Trulicity)
Outcome
DecreaseHbA1c efficacy estimand
Study
n: not reported in source
Comparator
Dulaglutide 1.5 mg weekly
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
3.0 mg weekly · 36 weeksAs given in this study (human).
Measurements
ETD
−0.17%
3.0 versus 1.5 mg efficacy estimand
Source sentences
Summary
Dulaglutide 3.0 mg was superior to 1.5 mg for reducing HbA_1c, using the efficacy estimand (ETD -0.17% [-1.9 mmol/mol]; P = 0.003) but not the treatment-regimen estimand (ETD -0.10% [-1.1 mmol/mol]; P = 0.096).
2 context sentences(design, population, supporting numbers)
Summary · context
To compare efficacy and safety of dulaglutide at doses of 3.0 and 4.5 mg versus 1.5 mg in patients with type 2 diabetes inadequately controlled with metformin.
Summary · context
Patients were randomly assigned to once-weekly dulaglutide 1.5 mg, 3.0 mg, or 4.5 mg for 52 weeks.
Report a problemFND-3339776803
04HumanRandomized controlled trialEfficacy outcome
In metformin-treated T2D, dulaglutide 3.0 mg was not superior to 1.5 mg under the treatment-regimen estimand.
In plain wordsIn patients taking metformin, the middle dulaglutide dose did not significantly outperform the lower dose for the treatment-regimen analysis.
Peptide
Dulaglutide (Trulicity)
Outcome
No significant changeHbA1c treatment-regimen estimand
Study
n: not reported in source
Comparator
Dulaglutide 1.5 mg weekly
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
3.0 mg weekly · 36 weeksAs given in this study (human).
Measurements
ETD
−0.1%
3.0 versus 1.5 mg treatment-regimen estimand
Source sentences
Summary
Dulaglutide 3.0 mg was superior to 1.5 mg for reducing HbA_1c, using the efficacy estimand (ETD -0.17% [-1.9 mmol/mol]; P = 0.003) but not the treatment-regimen estimand (ETD -0.10% [-1.1 mmol/mol]; P = 0.096).
2 context sentences(design, population, supporting numbers)
Summary · context
To compare efficacy and safety of dulaglutide at doses of 3.0 and 4.5 mg versus 1.5 mg in patients with type 2 diabetes inadequately controlled with metformin.
Summary · context
Patients were randomly assigned to once-weekly dulaglutide 1.5 mg, 3.0 mg, or 4.5 mg for 52 weeks.
Report a problemFND-3339776804
05HumanRandomized controlled trialEfficacy outcome
In metformin-treated T2D, dulaglutide 4.5 mg reduced weight more than 1.5 mg under the treatment-regimen estimand.
In plain wordsIn patients taking metformin, higher-dose dulaglutide reduced weight more than the lower dose.
Peptide
Dulaglutide (Trulicity)
Outcome
DecreaseBody weight treatment-regimen estimand
Study
n: not reported in source
Comparator
Dulaglutide 1.5 mg weekly
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Studied dose
4.5 mg weekly · 36 weeksAs given in this study (human).
Measurements
Weight change
−4.6 kg
4.5 mg treatment-regimen estimand
Weight change
−3 kg
1.5 mg treatment-regimen estimand
ETD
−1.6 kg
4.5 versus 1.5 mg
Source sentences
Summary
Dulaglutide 4.5 mg was superior to 1.5 mg for weight loss at 36 weeks for both estimands (treatment regimen: -4.6 vs. -3.0 kg, ETD -1.6 kg, P P < 0.001).
2 context sentences(design, population, supporting numbers)
Summary · context
To compare efficacy and safety of dulaglutide at doses of 3.0 and 4.5 mg versus 1.5 mg in patients with type 2 diabetes inadequately controlled with metformin.
Summary · context
Patients were randomly assigned to once-weekly dulaglutide 1.5 mg, 3.0 mg, or 4.5 mg for 52 weeks.
Report a problemFND-3339776805
06HumanRandomized controlled trialEfficacy outcome
In metformin-treated T2D, dulaglutide 4.5 mg reduced weight more than 1.5 mg under the efficacy estimand.
In plain wordsIn patients taking metformin, higher-dose dulaglutide reduced weight more than the lower dose during treatment.
Peptide
Dulaglutide (Trulicity)
Outcome
DecreaseBody weight efficacy estimand
Study
n: not reported in source
Comparator
Dulaglutide 1.5 mg weekly
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Studied dose
4.5 mg weekly · 36 weeksAs given in this study (human).
Measurements
Weight change
−4.7 kg
4.5 mg efficacy estimand
Weight change
−3.1 kg
1.5 mg efficacy estimand
ETD
−1.6 kg
4.5 versus 1.5 mg
Source sentences
Summary
Dulaglutide 4.5 mg was superior to 1.5 mg for weight loss at 36 weeks for both estimands (treatment regimen: -4.6 vs. -3.0 kg, ETD -1.6 kg, P P < 0.001).
2 context sentences(design, population, supporting numbers)
Summary · context
To compare efficacy and safety of dulaglutide at doses of 3.0 and 4.5 mg versus 1.5 mg in patients with type 2 diabetes inadequately controlled with metformin.
Summary · context
Patients were randomly assigned to once-weekly dulaglutide 1.5 mg, 3.0 mg, or 4.5 mg for 52 weeks.
Report a problemFND-3339776806
07HumanRandomized controlled trialSafety outcome
In metformin-treated T2D, nausea occurred in 13.4% receiving dulaglutide 1.5 mg.
In plain wordsIn patients taking metformin, nausea occurred with the lower dulaglutide dose.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableNausea with 1.5 mg
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
1.5 mg weekly · 36 weeksAs given in this study (human).
Measurements
Nausea
13.4%
1.5 mg
Source sentences
Summary
Common adverse events through 36 weeks included nausea (1.5 mg, 13.4%; 3 mg, 15.6%; 4.5 mg, 16.4%) and vomiting (1.5 mg, 5.6%; 3 mg, 8.3%; 4.5 mg, 9.3%).
2 context sentences(design, population, supporting numbers)
Summary · context
To compare efficacy and safety of dulaglutide at doses of 3.0 and 4.5 mg versus 1.5 mg in patients with type 2 diabetes inadequately controlled with metformin.
Summary · context
Patients were randomly assigned to once-weekly dulaglutide 1.5 mg, 3.0 mg, or 4.5 mg for 52 weeks.
Report a problemFND-3339776807
08HumanRandomized controlled trialSafety outcome
In metformin-treated T2D, nausea occurred in 15.6% receiving dulaglutide 3 mg.
In plain wordsIn patients taking metformin, nausea occurred with the middle dulaglutide dose.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableNausea with 3 mg
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
3 mg weekly · 36 weeksAs given in this study (human).
Measurements
Nausea
15.6%
3 mg
Source sentences
Summary
Common adverse events through 36 weeks included nausea (1.5 mg, 13.4%; 3 mg, 15.6%; 4.5 mg, 16.4%) and vomiting (1.5 mg, 5.6%; 3 mg, 8.3%; 4.5 mg, 9.3%).
2 context sentences(design, population, supporting numbers)
Summary · context
To compare efficacy and safety of dulaglutide at doses of 3.0 and 4.5 mg versus 1.5 mg in patients with type 2 diabetes inadequately controlled with metformin.
Summary · context
Patients were randomly assigned to once-weekly dulaglutide 1.5 mg, 3.0 mg, or 4.5 mg for 52 weeks.
Report a problemFND-3339776808
09HumanRandomized controlled trialSafety outcome
In metformin-treated T2D, nausea occurred in 16.4% receiving dulaglutide 4.5 mg.
In plain wordsIn patients taking metformin, nausea occurred with the higher dulaglutide dose.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableNausea with 4.5 mg
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
4.5 mg weekly · 36 weeksAs given in this study (human).
Measurements
Nausea
16.4%
4.5 mg
Source sentences
Summary
Common adverse events through 36 weeks included nausea (1.5 mg, 13.4%; 3 mg, 15.6%; 4.5 mg, 16.4%) and vomiting (1.5 mg, 5.6%; 3 mg, 8.3%; 4.5 mg, 9.3%).
2 context sentences(design, population, supporting numbers)
Summary · context
To compare efficacy and safety of dulaglutide at doses of 3.0 and 4.5 mg versus 1.5 mg in patients with type 2 diabetes inadequately controlled with metformin.
Summary · context
Patients were randomly assigned to once-weekly dulaglutide 1.5 mg, 3.0 mg, or 4.5 mg for 52 weeks.
Report a problemFND-3339776809
10HumanRandomized controlled trialSafety outcome
In metformin-treated T2D, vomiting occurred in 5.6% receiving dulaglutide 1.5 mg.
In plain wordsIn patients taking metformin, vomiting occurred with the lower dulaglutide dose.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableVomiting with 1.5 mg
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
1.5 mg weekly · 36 weeksAs given in this study (human).
Measurements
Vomiting
5.6%
1.5 mg
Source sentences
Summary
Common adverse events through 36 weeks included nausea (1.5 mg, 13.4%; 3 mg, 15.6%; 4.5 mg, 16.4%) and vomiting (1.5 mg, 5.6%; 3 mg, 8.3%; 4.5 mg, 9.3%).
2 context sentences(design, population, supporting numbers)
Summary · context
To compare efficacy and safety of dulaglutide at doses of 3.0 and 4.5 mg versus 1.5 mg in patients with type 2 diabetes inadequately controlled with metformin.
Summary · context
Patients were randomly assigned to once-weekly dulaglutide 1.5 mg, 3.0 mg, or 4.5 mg for 52 weeks.
Report a problemFND-3339776810
11HumanRandomized controlled trialSafety outcome
In metformin-treated T2D, vomiting occurred in 8.3% receiving dulaglutide 3 mg.
In plain wordsIn patients taking metformin, vomiting occurred with the middle dulaglutide dose.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableVomiting with 3 mg
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
3 mg weekly · 36 weeksAs given in this study (human).
Measurements
Vomiting
8.3%
3 mg
Source sentences
Summary
Common adverse events through 36 weeks included nausea (1.5 mg, 13.4%; 3 mg, 15.6%; 4.5 mg, 16.4%) and vomiting (1.5 mg, 5.6%; 3 mg, 8.3%; 4.5 mg, 9.3%).
2 context sentences(design, population, supporting numbers)
Summary · context
To compare efficacy and safety of dulaglutide at doses of 3.0 and 4.5 mg versus 1.5 mg in patients with type 2 diabetes inadequately controlled with metformin.
Summary · context
Patients were randomly assigned to once-weekly dulaglutide 1.5 mg, 3.0 mg, or 4.5 mg for 52 weeks.
Report a problemFND-3339776811
12HumanRandomized controlled trialSafety outcome
In metformin-treated T2D, vomiting occurred in 9.3% receiving dulaglutide 4.5 mg.
In plain wordsIn patients taking metformin, vomiting occurred with the higher dulaglutide dose.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableVomiting with 4.5 mg
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
4.5 mg weekly · 36 weeksAs given in this study (human).
Measurements
Vomiting
9.3%
4.5 mg
Source sentences
Summary
Common adverse events through 36 weeks included nausea (1.5 mg, 13.4%; 3 mg, 15.6%; 4.5 mg, 16.4%) and vomiting (1.5 mg, 5.6%; 3 mg, 8.3%; 4.5 mg, 9.3%).
2 context sentences(design, population, supporting numbers)
Summary · context
To compare efficacy and safety of dulaglutide at doses of 3.0 and 4.5 mg versus 1.5 mg in patients with type 2 diabetes inadequately controlled with metformin.
Summary · context
Patients were randomly assigned to once-weekly dulaglutide 1.5 mg, 3.0 mg, or 4.5 mg for 52 weeks.
Report a problemFND-3339776812

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

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT03495102

A Study of the Efficacy and Safety of Dulaglutide (LY2189265) in Participants With Type 2 Diabetes

Eli Lilly and Companyn = 1,8425 Apr 2018 to 10 Oct 2019

Diabetes Mellitus, Type 2

Trial page ClinicalTrials.govUpdated 12 Jun 2020

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, 02:25 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

MeSH terms

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