Efficacy and Safety of Once-Weekly Dulaglutide in Type 2 Diabetes Patients Using Insulin: Exploratory Subgroup Analysis by Insulin Regimen.

Onishi Y, Ishii H, Oura T, Takeuchi M

Diabetes therapy : research, treatment and education of diabetes and related disorders29 Jan 2020Cited by 2 (Europe PMC)

PMID31994009PMCIDPMC7048887DOI10.1007/s13300-020-00765-6PepBankPUB-31994009

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Summary

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

Results from this study8

8 results from studies that gave the peptide. 8 results from people.

01HumanRandomized controlled trialEfficacy outcome
In Japanese patients with T2DM using basal insulin, dulaglutide reduced HbA1c more than placebo.
In plain wordsIn Japanese patients using basal insulin, dulaglutide lowered HbA1c more than placebo.
Peptide
Dulaglutide (Trulicity)
Outcome
DecreaseHbA1c with basal insulin
Study
n: not reported in source
Comparator
Placebo with the same insulin regimen
Analysis
Exploratory
Outcome group
Glycemic control · Metabolic and weight
Studied dose
0.75 mg once weekly · 16 weeksAs given in this study (human).
Measurements
HbA1c difference
−1.62%
basal insulin
Source sentences
Summary
At week 16, least squares mean differences (95% CI) regarding changes from baseline in HbA1c for each insulin regimen versus placebo were: B: - 1.62% (- 1.96, - 1.28), PM: - 1.78% (- 2.25, - 1.30), and BB: - 1.15% (- 1.54, - 0.77); p < 0.001 dulaglutide vs. placebo for each subgroup.
2 context sentences(design, population, supporting numbers)
Summary · context
This multicenter study enrolled Japanese patients with T2DM and inadequate glycemic control [glycated hemoglobin A1c (HbA1c) ≥ 7.5% to ≤ 10.5%] on insulin therapy [basal (B), premixed (PM), or basal bolus (BB)] in combination with or without one or two oral antidiabetic agents.
Summary · context
Randomized participants received once-weekly dulaglutide 0.75 mg (n = 120) or placebo (n = 39) during a 16-week double-blind treatment period, and dulaglutide during a 36-week open-label extension.
Report a problemFND-3199400901
02HumanRandomized controlled trialEfficacy outcome
In Japanese patients with T2DM using premixed insulin, dulaglutide reduced HbA1c more than placebo.
In plain wordsIn Japanese patients using premixed insulin, dulaglutide lowered HbA1c more than placebo.
Peptide
Dulaglutide (Trulicity)
Outcome
DecreaseHbA1c with premixed insulin
Study
n: not reported in source
Comparator
Placebo with the same insulin regimen
Analysis
Exploratory
Outcome group
Glycemic control · Metabolic and weight
Studied dose
0.75 mg once weekly · 16 weeksAs given in this study (human).
Measurements
HbA1c difference
−1.78%
premixed insulin
Source sentences
Summary
At week 16, least squares mean differences (95% CI) regarding changes from baseline in HbA1c for each insulin regimen versus placebo were: B: - 1.62% (- 1.96, - 1.28), PM: - 1.78% (- 2.25, - 1.30), and BB: - 1.15% (- 1.54, - 0.77); p < 0.001 dulaglutide vs. placebo for each subgroup.
2 context sentences(design, population, supporting numbers)
Summary · context
This multicenter study enrolled Japanese patients with T2DM and inadequate glycemic control [glycated hemoglobin A1c (HbA1c) ≥ 7.5% to ≤ 10.5%] on insulin therapy [basal (B), premixed (PM), or basal bolus (BB)] in combination with or without one or two oral antidiabetic agents.
Summary · context
Randomized participants received once-weekly dulaglutide 0.75 mg (n = 120) or placebo (n = 39) during a 16-week double-blind treatment period, and dulaglutide during a 36-week open-label extension.
Report a problemFND-3199400902
03HumanRandomized controlled trialEfficacy outcome
In Japanese patients with T2DM using basal bolus insulin, dulaglutide reduced HbA1c more than placebo.
In plain wordsIn Japanese patients using basal bolus insulin, dulaglutide lowered HbA1c more than placebo.
Peptide
Dulaglutide (Trulicity)
Outcome
DecreaseHbA1c with basal bolus insulin
Study
n: not reported in source
Comparator
Placebo with the same insulin regimen
Analysis
Exploratory
Outcome group
Glycemic control · Metabolic and weight
Studied dose
0.75 mg once weekly · 16 weeksAs given in this study (human).
Measurements
HbA1c difference
−1.15%
basal bolus insulin
Source sentences
Summary
At week 16, least squares mean differences (95% CI) regarding changes from baseline in HbA1c for each insulin regimen versus placebo were: B: - 1.62% (- 1.96, - 1.28), PM: - 1.78% (- 2.25, - 1.30), and BB: - 1.15% (- 1.54, - 0.77); p < 0.001 dulaglutide vs. placebo for each subgroup.
2 context sentences(design, population, supporting numbers)
Summary · context
This multicenter study enrolled Japanese patients with T2DM and inadequate glycemic control [glycated hemoglobin A1c (HbA1c) ≥ 7.5% to ≤ 10.5%] on insulin therapy [basal (B), premixed (PM), or basal bolus (BB)] in combination with or without one or two oral antidiabetic agents.
Summary · context
Randomized participants received once-weekly dulaglutide 0.75 mg (n = 120) or placebo (n = 39) during a 16-week double-blind treatment period, and dulaglutide during a 36-week open-label extension.
Report a problemFND-3199400903
04HumanRandomized controlled trialEfficacy outcome
In Japanese patients with T2DM, body weight changes did not differ significantly between dulaglutide and placebo with any insulin regimen.
In plain wordsIn Japanese patients, weight changes did not differ significantly between dulaglutide and placebo with any insulin regimen.
Peptide
Dulaglutide (Trulicity)
Outcome
No significant changeBody weight by insulin regimen
Study
n: not reported in source
Comparator
Placebo with the same insulin regimen
Analysis
Exploratory
Outcome group
Body weight · Metabolic and weight
Studied dose
0.75 mg once weekly · 16 weeksAs given in this study (human).
Source sentences
Summary
No significant differences in body weight changes were observed between dulaglutide and placebo for any insulin regimen.
2 context sentences(design, population, supporting numbers)
Summary · context
This multicenter study enrolled Japanese patients with T2DM and inadequate glycemic control [glycated hemoglobin A1c (HbA1c) ≥ 7.5% to ≤ 10.5%] on insulin therapy [basal (B), premixed (PM), or basal bolus (BB)] in combination with or without one or two oral antidiabetic agents.
Summary · context
Randomized participants received once-weekly dulaglutide 0.75 mg (n = 120) or placebo (n = 39) during a 16-week double-blind treatment period, and dulaglutide during a 36-week open-label extension.
Report a problemFND-3199400904
05HumanRandomized controlled trialSafety outcome
In Japanese patients with T2DM receiving dulaglutide, gastrointestinal symptoms were the most common adverse events.
In plain wordsIn Japanese patients receiving dulaglutide, digestive symptoms were the most common side effects.
Peptide
Dulaglutide (Trulicity)
Outcome
Direction not reportedGastrointestinal symptoms
Study
n: not reported in source
Analysis
Exploratory
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
0.75 mg once weekly · 16 weeksAs given in this study (human).
Source sentences
Summary
Gastrointestinal symptoms were the most commonly observed adverse events in dulaglutide-treated patients.
2 context sentences(design, population, supporting numbers)
Summary · context
This multicenter study enrolled Japanese patients with T2DM and inadequate glycemic control [glycated hemoglobin A1c (HbA1c) ≥ 7.5% to ≤ 10.5%] on insulin therapy [basal (B), premixed (PM), or basal bolus (BB)] in combination with or without one or two oral antidiabetic agents.
Summary · context
Randomized participants received once-weekly dulaglutide 0.75 mg (n = 120) or placebo (n = 39) during a 16-week double-blind treatment period, and dulaglutide during a 36-week open-label extension.
Report a problemFND-3199400905
06HumanRandomized controlled trialSafety outcome
In Japanese patients using basal insulin, hypoglycemia occurred in 38.5% with dulaglutide versus 23.5% with placebo.
In plain wordsWith basal insulin, low blood sugar occurred in 38.5% of dulaglutide patients versus 23.5% of placebo patients.
Peptide
Dulaglutide (Trulicity)
Outcome
IncreaseHypoglycemia with basal insulin
Study
n: not reported in source
Comparator
Placebo with the same insulin regimen
Analysis
Exploratory
Outcome group
Adverse events · Metabolic and weight
Studied dose
0.75 mg once weekly · 16 weeksAs given in this study (human).
Measurements
Hypoglycemia incidence
38.5%
dulaglutide, basal insulin
Hypoglycemia incidence
23.5%
placebo, basal insulin
Source sentences
Summary
Hypoglycemia incidence rates were: B: dulaglutide 38.5% vs. placebo 23.5%; PM: dulaglutide 38.5% vs. placebo 44.4%; BB: dulaglutide 50.0% vs. placebo 30.8%.
2 context sentences(design, population, supporting numbers)
Summary · context
This multicenter study enrolled Japanese patients with T2DM and inadequate glycemic control [glycated hemoglobin A1c (HbA1c) ≥ 7.5% to ≤ 10.5%] on insulin therapy [basal (B), premixed (PM), or basal bolus (BB)] in combination with or without one or two oral antidiabetic agents.
Summary · context
Randomized participants received once-weekly dulaglutide 0.75 mg (n = 120) or placebo (n = 39) during a 16-week double-blind treatment period, and dulaglutide during a 36-week open-label extension.
Report a problemFND-3199400906
07HumanRandomized controlled trialSafety outcome
In Japanese patients using premixed insulin, hypoglycemia occurred in 38.5% with dulaglutide versus 44.4% with placebo.
In plain wordsWith premixed insulin, low blood sugar occurred in 38.5% of dulaglutide patients versus 44.4% of placebo patients.
Peptide
Dulaglutide (Trulicity)
Outcome
DecreaseHypoglycemia with premixed insulin
Study
n: not reported in source
Comparator
Placebo with the same insulin regimen
Analysis
Exploratory
Outcome group
Adverse events · Metabolic and weight
Studied dose
0.75 mg once weekly · 16 weeksAs given in this study (human).
Measurements
Hypoglycemia incidence
38.5%
dulaglutide, premixed insulin
Hypoglycemia incidence
44.4%
placebo, premixed insulin
Source sentences
Summary
Hypoglycemia incidence rates were: B: dulaglutide 38.5% vs. placebo 23.5%; PM: dulaglutide 38.5% vs. placebo 44.4%; BB: dulaglutide 50.0% vs. placebo 30.8%.
2 context sentences(design, population, supporting numbers)
Summary · context
This multicenter study enrolled Japanese patients with T2DM and inadequate glycemic control [glycated hemoglobin A1c (HbA1c) ≥ 7.5% to ≤ 10.5%] on insulin therapy [basal (B), premixed (PM), or basal bolus (BB)] in combination with or without one or two oral antidiabetic agents.
Summary · context
Randomized participants received once-weekly dulaglutide 0.75 mg (n = 120) or placebo (n = 39) during a 16-week double-blind treatment period, and dulaglutide during a 36-week open-label extension.
Report a problemFND-3199400907
08HumanRandomized controlled trialSafety outcome
In Japanese patients using basal bolus insulin, hypoglycemia occurred in 50.0% with dulaglutide versus 30.8% with placebo.
In plain wordsWith basal bolus insulin, low blood sugar occurred in 50.0% of dulaglutide patients versus 30.8% of placebo patients.
Peptide
Dulaglutide (Trulicity)
Outcome
IncreaseHypoglycemia with basal bolus insulin
Study
n: not reported in source
Comparator
Placebo with the same insulin regimen
Analysis
Exploratory
Outcome group
Adverse events · Metabolic and weight
Studied dose
0.75 mg once weekly · 16 weeksAs given in this study (human).
Measurements
Hypoglycemia incidence
50%
dulaglutide, basal bolus insulin
Hypoglycemia incidence
30.8%
placebo, basal bolus insulin
Source sentences
Summary
Hypoglycemia incidence rates were: B: dulaglutide 38.5% vs. placebo 23.5%; PM: dulaglutide 38.5% vs. placebo 44.4%; BB: dulaglutide 50.0% vs. placebo 30.8%.
2 context sentences(design, population, supporting numbers)
Summary · context
This multicenter study enrolled Japanese patients with T2DM and inadequate glycemic control [glycated hemoglobin A1c (HbA1c) ≥ 7.5% to ≤ 10.5%] on insulin therapy [basal (B), premixed (PM), or basal bolus (BB)] in combination with or without one or two oral antidiabetic agents.
Summary · context
Randomized participants received once-weekly dulaglutide 0.75 mg (n = 120) or placebo (n = 39) during a 16-week double-blind treatment period, and dulaglutide during a 36-week open-label extension.
Report a problemFND-3199400908

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 4Results postedNCT02750410

A Study of Dulaglutide in Japanese Participants With Type 2 Diabetes

Eli Lilly and Companyn = 159Aug 2016 to 18 Jun 2018

Type 2 Diabetes

Trial page ClinicalTrials.govUpdated 24 Sept 2019

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

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