Efficacy and Safety of Once-Weekly Dulaglutide Versus Insulin Glargine in Patients With Type 2 Diabetes on Metformin and Glimepiride (AWARD-2).

Giorgino F, Benroubi M, Sun JH, Zimmermann AG, Pechtner V

Diabetes care18 Jun 2015Cited by 203 (Europe PMC)

PMID26089386DOI10.2337/dc14-1625PepBankPUB-26089386

Publisher page PubMedAsk about this study

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 study11

11 results from studies that gave the peptide. 11 results from people.

01HumanRandomized controlled trialEfficacy outcome
In type 2 diabetes, dulaglutide 1.5 mg reduced HbA1c more than glargine.
In plain wordsIn type 2 diabetes, dulaglutide 1.5 mg lowered HbA1c more than glargine.
Peptide
Dulaglutide (Trulicity)
Outcome
DecreaseHbA1c
Study
n: not reported in source
Comparator
insulin glargine
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1.5 mg weekly · 52 weeksAs given in this study (human).
Measurements
HbA1c change from baseline
−1.08%
dulaglutide 1.5 mg
HbA1c change from baseline
−0.63%
glargine
Source sentences
Summary
The least squares mean ± SE HbA1c change from baseline to the primary end point was -1.08 ± 0.06% (-11.8 ± 0.7 mmol/mol) for dulaglutide 1.5 mg, -0.76 ± 0.06% (-8.3 ± 0.7 mmol/mol) for dulaglutide 0.75 mg, and -0.63 ± 0.06% (-6.9 ± 0.7 mmol/mol) for glargine
Summary
Statistical criteria for superiority were met with dulaglutide 1.5 mg and for noninferiority with dulaglutide 0.75 mg.
2 context sentences(design, population, supporting numbers)
Summary · context
This study compared the efficacy and safety of once-weekly dulaglutide, a glucagon-like peptide-1 receptor agonist, with daily insulin glargine, both combined with maximally tolerated doses of metformin and glimepiride in patients with type 2 diabetes.
Summary · context
In this 78-week, open-label study, 810 patients were randomized to dulaglutide 1.5 mg, dulaglutide 0.75 mg, or glargine.
Report a problemFND-2608938601
02HumanRandomized controlled trialEfficacy outcome
In type 2 diabetes, dulaglutide 0.75 mg met HbA1c noninferiority criteria versus glargine.
In plain wordsIn type 2 diabetes, dulaglutide 0.75 mg met HbA1c noninferiority criteria versus glargine.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableHbA1c
Study
n: not reported in source
Comparator
insulin glargine
Outcome group
Glycemic control · Metabolic and weight
Studied dose
0.75 mg weekly · 52 weeksAs given in this study (human).
Measurements
HbA1c change from baseline
−0.76%
dulaglutide 0.75 mg
HbA1c change from baseline
−0.63%
glargine
Source sentences
Summary
Statistical criteria for superiority were met with dulaglutide 1.5 mg and for noninferiority with dulaglutide 0.75 mg.
Summary
The least squares mean ± SE HbA1c change from baseline to the primary end point was -1.08 ± 0.06% (-11.8 ± 0.7 mmol/mol) for dulaglutide 1.5 mg, -0.76 ± 0.06% (-8.3 ± 0.7 mmol/mol) for dulaglutide 0.75 mg, and -0.63 ± 0.06% (-6.9 ± 0.7 mmol/mol) for glargine
2 context sentences(design, population, supporting numbers)
Summary · context
This study compared the efficacy and safety of once-weekly dulaglutide, a glucagon-like peptide-1 receptor agonist, with daily insulin glargine, both combined with maximally tolerated doses of metformin and glimepiride in patients with type 2 diabetes.
Summary · context
In this 78-week, open-label study, 810 patients were randomized to dulaglutide 1.5 mg, dulaglutide 0.75 mg, or glargine.
Report a problemFND-2608938602
03HumanRandomized controlled trialEfficacy outcome
In type 2 diabetes, more patients reached HbA1c below 7.0% with dulaglutide 1.5 mg than glargine.
In plain wordsIn type 2 diabetes, more patients reached HbA1c below 7.0% with dulaglutide 1.5 mg than glargine.
Peptide
Dulaglutide (Trulicity)
Outcome
IncreaseHbA1c below 7.0%
Study
n: not reported in source
Comparator
insulin glargine
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1.5 mg weeklyAs given in this study (human).
Source sentences
Summary
More patients on dulaglutide 1.5 mg achieved HbA1c targets <7.0% (53 mmol/mol) versus glargine (P < 0.001).
2 context sentences(design, population, supporting numbers)
Summary · context
This study compared the efficacy and safety of once-weekly dulaglutide, a glucagon-like peptide-1 receptor agonist, with daily insulin glargine, both combined with maximally tolerated doses of metformin and glimepiride in patients with type 2 diabetes.
Summary · context
In this 78-week, open-label study, 810 patients were randomized to dulaglutide 1.5 mg, dulaglutide 0.75 mg, or glargine.
Report a problemFND-2608938603
04HumanRandomized controlled trialEfficacy outcome
In type 2 diabetes, body weight decreased with dulaglutide but increased with glargine.
In plain wordsIn type 2 diabetes, weight fell with dulaglutide and rose with glargine.
Peptide
Dulaglutide (Trulicity)
Outcome
DecreaseBody weight
Study
n: not reported in source
Comparator
insulin glargine
Outcome group
Body weight · Metabolic and weight
Studied dose
Dose not stated
Source sentences
Summary
Body weight decreased with dulaglutide and increased with glargine.
2 context sentences(design, population, supporting numbers)
Summary · context
This study compared the efficacy and safety of once-weekly dulaglutide, a glucagon-like peptide-1 receptor agonist, with daily insulin glargine, both combined with maximally tolerated doses of metformin and glimepiride in patients with type 2 diabetes.
Summary · context
In this 78-week, open-label study, 810 patients were randomized to dulaglutide 1.5 mg, dulaglutide 0.75 mg, or glargine.
Report a problemFND-2608938604
05HumanRandomized controlled trialSafety outcome
In type 2 diabetes, total hypoglycemia rates were lower with dulaglutide than glargine.
In plain wordsIn type 2 diabetes, low blood sugar rates were lower with dulaglutide than glargine.
Peptide
Dulaglutide (Trulicity)
Outcome
DecreaseTotal hypoglycemia
Study
n: not reported in source
Comparator
insulin glargine
Outcome group
Adverse events · Metabolic and weight
Studied dose
Dose not stated
Source sentences
Summary
Total hypoglycemia rates were lower with dulaglutide; severe hypoglycemia was minimal.
2 context sentences(design, population, supporting numbers)
Summary · context
This study compared the efficacy and safety of once-weekly dulaglutide, a glucagon-like peptide-1 receptor agonist, with daily insulin glargine, both combined with maximally tolerated doses of metformin and glimepiride in patients with type 2 diabetes.
Summary · context
In this 78-week, open-label study, 810 patients were randomized to dulaglutide 1.5 mg, dulaglutide 0.75 mg, or glargine.
Report a problemFND-2608938605
06HumanRandomized controlled trialSafety outcome
In type 2 diabetes, severe hypoglycemia was minimal with dulaglutide.
In plain wordsIn type 2 diabetes, severe low blood sugar was minimal with dulaglutide.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableSevere hypoglycemia
Study
n: not reported in source
Outcome group
Adverse events · Metabolic and weight
Studied dose
Dose not stated
Source sentences
Summary
Total hypoglycemia rates were lower with dulaglutide; severe hypoglycemia was minimal.
2 context sentences(design, population, supporting numbers)
Summary · context
This study compared the efficacy and safety of once-weekly dulaglutide, a glucagon-like peptide-1 receptor agonist, with daily insulin glargine, both combined with maximally tolerated doses of metformin and glimepiride in patients with type 2 diabetes.
Summary · context
In this 78-week, open-label study, 810 patients were randomized to dulaglutide 1.5 mg, dulaglutide 0.75 mg, or glargine.
Report a problemFND-2608938606
07HumanRandomized controlled trialSafety outcome
In type 2 diabetes, pancreatic enzymes increased with dulaglutide.
In plain wordsIn type 2 diabetes, pancreatic enzyme levels increased with dulaglutide.
Peptide
Dulaglutide (Trulicity)
Outcome
IncreasePancreatic enzymes
Study
n: not reported in source
Outcome group
Adverse events · Gastrointestinal
Studied dose
Dose not stated
Source sentences
Summary
Increases in pancreatic enzymes were observed for dulaglutide.
2 context sentences(design, population, supporting numbers)
Summary · context
This study compared the efficacy and safety of once-weekly dulaglutide, a glucagon-like peptide-1 receptor agonist, with daily insulin glargine, both combined with maximally tolerated doses of metformin and glimepiride in patients with type 2 diabetes.
Summary · context
In this 78-week, open-label study, 810 patients were randomized to dulaglutide 1.5 mg, dulaglutide 0.75 mg, or glargine.
Report a problemFND-2608938607
08HumanRandomized controlled trialSafety outcome
In type 2 diabetes, nausea was more common with dulaglutide 1.5 mg than glargine.
In plain wordsIn type 2 diabetes, nausea was more common with dulaglutide 1.5 mg than glargine.
Peptide
Dulaglutide (Trulicity)
Outcome
IncreaseNausea
Study
n: not reported in source
Comparator
insulin glargine
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
1.5 mg weeklyAs given in this study (human).
Measurements
Nausea incidence
15.4%
dulaglutide 1.5 mg
Nausea incidence
1.5%
glargine
Source sentences
Summary
Incidence of nausea (15.4, 7.7, and 1.5%) and diarrhea (10.6, 9.2, and 5.7%) were more common with dulaglutide 1.5 mg and 0.75 mg than with glargine.
2 context sentences(design, population, supporting numbers)
Summary · context
This study compared the efficacy and safety of once-weekly dulaglutide, a glucagon-like peptide-1 receptor agonist, with daily insulin glargine, both combined with maximally tolerated doses of metformin and glimepiride in patients with type 2 diabetes.
Summary · context
In this 78-week, open-label study, 810 patients were randomized to dulaglutide 1.5 mg, dulaglutide 0.75 mg, or glargine.
Report a problemFND-2608938608
09HumanRandomized controlled trialSafety outcome
In type 2 diabetes, nausea was more common with dulaglutide 0.75 mg than glargine.
In plain wordsIn type 2 diabetes, nausea was more common with dulaglutide 0.75 mg than glargine.
Peptide
Dulaglutide (Trulicity)
Outcome
IncreaseNausea
Study
n: not reported in source
Comparator
insulin glargine
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
0.75 mg weeklyAs given in this study (human).
Measurements
Nausea incidence
7.7%
dulaglutide 0.75 mg
Nausea incidence
1.5%
glargine
Source sentences
Summary
Incidence of nausea (15.4, 7.7, and 1.5%) and diarrhea (10.6, 9.2, and 5.7%) were more common with dulaglutide 1.5 mg and 0.75 mg than with glargine.
2 context sentences(design, population, supporting numbers)
Summary · context
This study compared the efficacy and safety of once-weekly dulaglutide, a glucagon-like peptide-1 receptor agonist, with daily insulin glargine, both combined with maximally tolerated doses of metformin and glimepiride in patients with type 2 diabetes.
Summary · context
In this 78-week, open-label study, 810 patients were randomized to dulaglutide 1.5 mg, dulaglutide 0.75 mg, or glargine.
Report a problemFND-2608938609
10HumanRandomized controlled trialSafety outcome
In type 2 diabetes, diarrhea was more common with dulaglutide 1.5 mg than glargine.
In plain wordsIn type 2 diabetes, diarrhea was more common with dulaglutide 1.5 mg than glargine.
Peptide
Dulaglutide (Trulicity)
Outcome
IncreaseDiarrhea
Study
n: not reported in source
Comparator
insulin glargine
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
1.5 mg weeklyAs given in this study (human).
Measurements
Diarrhea incidence
10.6%
dulaglutide 1.5 mg
Diarrhea incidence
5.7%
glargine
Source sentences
Summary
Incidence of nausea (15.4, 7.7, and 1.5%) and diarrhea (10.6, 9.2, and 5.7%) were more common with dulaglutide 1.5 mg and 0.75 mg than with glargine.
2 context sentences(design, population, supporting numbers)
Summary · context
This study compared the efficacy and safety of once-weekly dulaglutide, a glucagon-like peptide-1 receptor agonist, with daily insulin glargine, both combined with maximally tolerated doses of metformin and glimepiride in patients with type 2 diabetes.
Summary · context
In this 78-week, open-label study, 810 patients were randomized to dulaglutide 1.5 mg, dulaglutide 0.75 mg, or glargine.
Report a problemFND-2608938610
11HumanRandomized controlled trialSafety outcome
In type 2 diabetes, diarrhea was more common with dulaglutide 0.75 mg than glargine.
In plain wordsIn type 2 diabetes, diarrhea was more common with dulaglutide 0.75 mg than glargine.
Peptide
Dulaglutide (Trulicity)
Outcome
IncreaseDiarrhea
Study
n: not reported in source
Comparator
insulin glargine
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
0.75 mg weeklyAs given in this study (human).
Measurements
Diarrhea incidence
9.2%
dulaglutide 0.75 mg
Diarrhea incidence
5.7%
insulin glargine
Source sentences
Summary
Incidence of nausea (15.4, 7.7, and 1.5%) and diarrhea (10.6, 9.2, and 5.7%) were more common with dulaglutide 1.5 mg and 0.75 mg than with glargine.
2 context sentences(design, population, supporting numbers)
Summary · context
This study compared the efficacy and safety of once-weekly dulaglutide, a glucagon-like peptide-1 receptor agonist, with daily insulin glargine, both combined with maximally tolerated doses of metformin and glimepiride in patients with type 2 diabetes.
Summary · context
In this 78-week, open-label study, 810 patients were randomized to dulaglutide 1.5 mg, dulaglutide 0.75 mg, or glargine.
Report a problemFND-2608938611

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

Registered trials2

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

2 trials · 2 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedNot applicableNCT03590626

Effect of Dulaglutide on Liver Fat in Patients With Type 2 Diabetes and Nonalcoholic Fatty Liver Disease

Medanta, The Medicity, Indian = 601 Jan 2019 to 18 Feb 2020

Non Alcoholic Fatty Liver Disease · Type2 Diabetes Mellitus

Trial page ClinicalTrials.govUpdated 20 Feb 2020

CompletedPhase 3Results postedNCT01075282

A Study in Participants With Type 2 Diabetes Mellitus (AWARD-2)

Eli Lilly and Companyn = 810Feb 2010 to Nov 2012

Diabetes Mellitus, Type 2

Trial page ClinicalTrials.govUpdated 16 Jan 2015

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

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