Efficacy and safety of dulaglutide monotherapy versus metformin in type 2 diabetes in a randomized controlled trial (AWARD-3).

Umpierrez G, Tofé Povedano S, Pérez Manghi F, Shurzinske L, Pechtner V

Diabetes care19 May 2014Cited by 272 (Europe PMC)

PMID24842985DOI10.2337/dc13-2759PepBankPUB-24842985

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 study10

10 results from studies that gave the peptide. 10 results from people.

01HumanRandomized controlled trialEfficacy outcome
In type 2 diabetes, dulaglutide 1.5 mg reduced HbA1c more than metformin.
In plain wordsIn type 2 diabetes, dulaglutide 1.5 mg lowered HbA1c more than metformin.
Peptide
Dulaglutide (Trulicity)
Outcome
DecreaseHbA1c
Study
n: not reported in source
Comparator
metformin
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1.5 mg weekly · subcutaneous · 26 weeksAs given in this study (human).
Measurements
HbA1c change
−0.78%
dulaglutide 1.5 mg
HbA1c difference
−0.22%
versus metformin
HbA1c change
−0.56%
metformin
Source sentences
Summary
Dulaglutide 1.5 and 0.75 mg were superior to metformin (LS mean difference): -0.22% (-2.4 mmol/mol) and -0.15% (-1.6 mmol/mol) (one-sided P < 0.025, both comparisons), respectively.
4 context sentences(design, population, supporting numbers)
Summary · context
At 26 weeks, changes from baseline HbA1c (least squares [LS] mean ± SE) were: dulaglutide 1.5 mg, -0.78 ± 0.06% (-8.5 ± 0.70 mmol/mol); dulaglutide 0.75 mg, -0.71 ± 0.06% (-7.8 ± 0.70 mmol/mol); and metformin, -0.56 ± 0.06% (-6.1 ± 0.70 mmol/mol).
Summary · context
The primary objective compared dulaglutide 1.5 mg and metformin on change from baseline glycosylated hemoglobin A1c (HbA1c) at 26 weeks.
Summary · context
This 52-week double-blind study randomized patients to subcutaneous dulaglutide 1.5 mg, dulaglutide 0.75 mg, or metformin.
Summary · context
Patients (N = 807) had HbA1c ≥6.5% (≥48 mmol/mol) and ≤9.5% (≤80 mmol/mol) with diet and exercise alone or low-dose oral antihyperglycemic medication (OAM) monotherapy; OAMs were discontinued at beginning of lead-in period.
Report a problemFND-2484298501
02HumanRandomized controlled trialEfficacy outcome
In type 2 diabetes, dulaglutide 0.75 mg reduced HbA1c more than metformin.
In plain wordsIn type 2 diabetes, dulaglutide 0.75 mg lowered HbA1c more than metformin.
Peptide
Dulaglutide (Trulicity)
Outcome
DecreaseHbA1c
Study
n: not reported in source
Comparator
metformin
Outcome group
Glycemic control · Metabolic and weight
Studied dose
0.75 mg weekly · subcutaneous · 26 weeksAs given in this study (human).
Measurements
HbA1c change
−0.71%
dulaglutide 0.75 mg
HbA1c difference
−0.15%
versus metformin
HbA1c change
−0.56%
metformin
Source sentences
Summary
Dulaglutide 1.5 and 0.75 mg were superior to metformin (LS mean difference): -0.22% (-2.4 mmol/mol) and -0.15% (-1.6 mmol/mol) (one-sided P < 0.025, both comparisons), respectively.
3 context sentences(design, population, supporting numbers)
Summary · context
At 26 weeks, changes from baseline HbA1c (least squares [LS] mean ± SE) were: dulaglutide 1.5 mg, -0.78 ± 0.06% (-8.5 ± 0.70 mmol/mol); dulaglutide 0.75 mg, -0.71 ± 0.06% (-7.8 ± 0.70 mmol/mol); and metformin, -0.56 ± 0.06% (-6.1 ± 0.70 mmol/mol).
Summary · context
This 52-week double-blind study randomized patients to subcutaneous dulaglutide 1.5 mg, dulaglutide 0.75 mg, or metformin.
Summary · context
Patients (N = 807) had HbA1c ≥6.5% (≥48 mmol/mol) and ≤9.5% (≤80 mmol/mol) with diet and exercise alone or low-dose oral antihyperglycemic medication (OAM) monotherapy; OAMs were discontinued at beginning of lead-in period.
Report a problemFND-2484298502
03HumanRandomized controlled trialEfficacy outcome
In type 2 diabetes, more patients reached HbA1c below 7.0% with dulaglutide 1.5 mg than metformin.
In plain wordsIn type 2 diabetes, more patients reached HbA1c below 7.0% with dulaglutide 1.5 mg than metformin.
Peptide
Dulaglutide (Trulicity)
Outcome
IncreaseHbA1c below 7.0%
Study
n: not reported in source
Comparator
metformin
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1.5 mg weekly · subcutaneousAs given in this study (human).
Source sentences
Summary
Greater percentages reached HbA1c targets <7.0% (<53 mmol/mol) and ≤6.5% (≤48 mmol/mol) with dulaglutide 1.5 and 0.75 mg compared with metformin (P < 0.05, all comparisons).
2 context sentences(design, population, supporting numbers)
Summary · context
This 52-week double-blind study randomized patients to subcutaneous dulaglutide 1.5 mg, dulaglutide 0.75 mg, or metformin.
Summary · context
Patients (N = 807) had HbA1c ≥6.5% (≥48 mmol/mol) and ≤9.5% (≤80 mmol/mol) with diet and exercise alone or low-dose oral antihyperglycemic medication (OAM) monotherapy; OAMs were discontinued at beginning of lead-in period.
Report a problemFND-2484298503
04HumanRandomized controlled trialEfficacy outcome
In type 2 diabetes, more patients reached HbA1c below 7.0% with dulaglutide 0.75 mg than metformin.
In plain wordsIn type 2 diabetes, more patients reached HbA1c below 7.0% with dulaglutide 0.75 mg than metformin.
Peptide
Dulaglutide (Trulicity)
Outcome
IncreaseHbA1c below 7.0%
Study
n: not reported in source
Comparator
metformin
Outcome group
Glycemic control · Metabolic and weight
Studied dose
0.75 mg weekly · subcutaneousAs given in this study (human).
Source sentences
Summary
Greater percentages reached HbA1c targets <7.0% (<53 mmol/mol) and ≤6.5% (≤48 mmol/mol) with dulaglutide 1.5 and 0.75 mg compared with metformin (P < 0.05, all comparisons).
2 context sentences(design, population, supporting numbers)
Summary · context
This 52-week double-blind study randomized patients to subcutaneous dulaglutide 1.5 mg, dulaglutide 0.75 mg, or metformin.
Summary · context
Patients (N = 807) had HbA1c ≥6.5% (≥48 mmol/mol) and ≤9.5% (≤80 mmol/mol) with diet and exercise alone or low-dose oral antihyperglycemic medication (OAM) monotherapy; OAMs were discontinued at beginning of lead-in period.
Report a problemFND-2484298504
05HumanRandomized controlled trialEfficacy outcome
In type 2 diabetes, more patients reached HbA1c at most 6.5% with dulaglutide 1.5 mg than metformin.
In plain wordsIn type 2 diabetes, more patients reached HbA1c at most 6.5% with dulaglutide 1.5 mg than metformin.
Peptide
Dulaglutide (Trulicity)
Outcome
IncreaseHbA1c at most 6.5%
Study
n: not reported in source
Comparator
metformin
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1.5 mg weekly · subcutaneousAs given in this study (human).
Source sentences
Summary
Greater percentages reached HbA1c targets <7.0% (<53 mmol/mol) and ≤6.5% (≤48 mmol/mol) with dulaglutide 1.5 and 0.75 mg compared with metformin (P < 0.05, all comparisons).
2 context sentences(design, population, supporting numbers)
Summary · context
This 52-week double-blind study randomized patients to subcutaneous dulaglutide 1.5 mg, dulaglutide 0.75 mg, or metformin.
Summary · context
Patients (N = 807) had HbA1c ≥6.5% (≥48 mmol/mol) and ≤9.5% (≤80 mmol/mol) with diet and exercise alone or low-dose oral antihyperglycemic medication (OAM) monotherapy; OAMs were discontinued at beginning of lead-in period.
Report a problemFND-2484298505
06HumanRandomized controlled trialEfficacy outcome
In type 2 diabetes, more patients reached HbA1c at most 6.5% with dulaglutide 0.75 mg than metformin.
In plain wordsIn type 2 diabetes, more patients reached HbA1c at most 6.5% with dulaglutide 0.75 mg than metformin.
Peptide
Dulaglutide (Trulicity)
Outcome
IncreaseHbA1c at most 6.5%
Study
n: not reported in source
Comparator
metformin
Outcome group
Glycemic control · Metabolic and weight
Studied dose
0.75 mg weekly · subcutaneousAs given in this study (human).
Source sentences
Summary
Greater percentages reached HbA1c targets <7.0% (<53 mmol/mol) and ≤6.5% (≤48 mmol/mol) with dulaglutide 1.5 and 0.75 mg compared with metformin (P < 0.05, all comparisons).
2 context sentences(design, population, supporting numbers)
Summary · context
This 52-week double-blind study randomized patients to subcutaneous dulaglutide 1.5 mg, dulaglutide 0.75 mg, or metformin.
Summary · context
Patients (N = 807) had HbA1c ≥6.5% (≥48 mmol/mol) and ≤9.5% (≤80 mmol/mol) with diet and exercise alone or low-dose oral antihyperglycemic medication (OAM) monotherapy; OAMs were discontinued at beginning of lead-in period.
Report a problemFND-2484298506
07HumanRandomized controlled trialSafety outcome
In type 2 diabetes treated with dulaglutide, no severe hypoglycemia was reported.
In plain wordsIn type 2 diabetes treated with dulaglutide, no severe low blood sugar was reported.
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 · subcutaneousAs given in this study (human).
Source sentences
Summary
No severe hypoglycemia was reported.
2 context sentences(design, population, supporting numbers)
Summary · context
This 52-week double-blind study randomized patients to subcutaneous dulaglutide 1.5 mg, dulaglutide 0.75 mg, or metformin.
Summary · context
Patients (N = 807) had HbA1c ≥6.5% (≥48 mmol/mol) and ≤9.5% (≤80 mmol/mol) with diet and exercise alone or low-dose oral antihyperglycemic medication (OAM) monotherapy; OAMs were discontinued at beginning of lead-in period.
Report a problemFND-2484298507
08HumanRandomized controlled trialEfficacy outcome
In type 2 diabetes, weight reduction was similar with dulaglutide 1.5 mg and metformin.
In plain wordsIn type 2 diabetes, weight loss was similar with dulaglutide 1.5 mg and metformin.
Peptide
Dulaglutide (Trulicity)
Outcome
No significant changeWeight reduction
Study
n: not reported in source
Comparator
metformin
Outcome group
Body weight · Metabolic and weight
Studied dose
1.5 mg weekly · subcutaneousAs given in this study (human).
Source sentences
Summary
Compared with metformin, decrease in weight was similar with dulaglutide 1.5 mg and smaller with dulaglutide 0.75 mg.
2 context sentences(design, population, supporting numbers)
Summary · context
This 52-week double-blind study randomized patients to subcutaneous dulaglutide 1.5 mg, dulaglutide 0.75 mg, or metformin.
Summary · context
Patients (N = 807) had HbA1c ≥6.5% (≥48 mmol/mol) and ≤9.5% (≤80 mmol/mol) with diet and exercise alone or low-dose oral antihyperglycemic medication (OAM) monotherapy; OAMs were discontinued at beginning of lead-in period.
Report a problemFND-2484298508
09HumanRandomized controlled trialEfficacy outcome
In type 2 diabetes, weight reduction was smaller with dulaglutide 0.75 mg than metformin.
In plain wordsIn type 2 diabetes, weight loss was smaller with dulaglutide 0.75 mg than metformin.
Peptide
Dulaglutide (Trulicity)
Outcome
DecreaseWeight reduction
Study
n: not reported in source
Comparator
metformin
Outcome group
Body weight · Metabolic and weight
Studied dose
0.75 mg weekly · subcutaneousAs given in this study (human).
Source sentences
Summary
Compared with metformin, decrease in weight was similar with dulaglutide 1.5 mg and smaller with dulaglutide 0.75 mg.
2 context sentences(design, population, supporting numbers)
Summary · context
This 52-week double-blind study randomized patients to subcutaneous dulaglutide 1.5 mg, dulaglutide 0.75 mg, or metformin.
Summary · context
Patients (N = 807) had HbA1c ≥6.5% (≥48 mmol/mol) and ≤9.5% (≤80 mmol/mol) with diet and exercise alone or low-dose oral antihyperglycemic medication (OAM) monotherapy; OAMs were discontinued at beginning of lead-in period.
Report a problemFND-2484298509
10HumanRandomized controlled trialSafety outcome
In type 2 diabetes, nausea, diarrhea and vomiting were the most common adverse events, and incidences were similar with dulaglutide and metformin.
In plain wordsIn type 2 diabetes, nausea, diarrhea and vomiting were the most common side effects, with similar rates for dulaglutide and metformin.
Peptide
Dulaglutide (Trulicity)
Outcome
No significant changeNausea, diarrhea and vomiting incidence
Study
n: not reported in source
Comparator
metformin
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
Dose not stated · subcutaneous · 52 weeksAs given in this study (human).
Source sentences
Summary
Over 52 weeks, nausea, diarrhea, and vomiting were the most common adverse events; incidences were similar between dulaglutide and metformin.
2 context sentences(design, population, supporting numbers)
Summary · context
This 52-week double-blind study randomized patients to subcutaneous dulaglutide 1.5 mg, dulaglutide 0.75 mg, or metformin.
Summary · context
Patients (N = 807) had HbA1c ≥6.5% (≥48 mmol/mol) and ≤9.5% (≤80 mmol/mol) with diet and exercise alone or low-dose oral antihyperglycemic medication (OAM) monotherapy; OAMs were discontinued at beginning of lead-in period.
Report a problemFND-2484298510

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 postedNCT01126580

A Study in Participants With Type 2 Diabetes Mellitus (AWARD-3)

Eli Lilly and Companyn = 807May 2010 to Jun 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

Subjects

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