Once-weekly dulaglutide versus bedtime insulin glargine, both in combination with prandial insulin lispro, in patients with type 2 diabetes (AWARD-4): a randomised, open-label, phase 3, non-inferiority study.

Blonde L, Jendle J, Gross J, Woo V, Jiang H, Fahrbach JL, Milicevic Z

Lancet (London, England)1 May 2015Cited by 185 (Europe PMC)

PMID26009229DOI10.1016/s0140-6736(15)60936-9PepBankPUB-26009229

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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 study9

9 results from studies that gave the peptide. 9 results from people.

01HumanRandomized controlled trialEfficacy outcome
Dulaglutide 1·5 mg reduced HbA1c more than glargine at week 26 with background lispro.
In plain wordsWith lispro, dulaglutide 1·5 mg lowered HbA1c more than glargine at week 26.
Peptide
Dulaglutide (Trulicity)
Outcome
DecreaseHbA1c change
Study
n: not reported in source
Comparator
Insulin glargine with prandial insulin lispro
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1·5 mg once weekly · 26 weeksAs given in this study (human).
Measurements
HbA1c change from baseline
−1.64%
dulaglutide 1·5 mg
HbA1c change from baseline
−1.41%
glargine
HbA1c adjusted mean difference versus glargine
−0.22%
dulaglutide 1·5 mg
Source sentences
Summary
At 26 weeks, the adjusted mean change in HbA1c was greater in patients receiving dulaglutide 1·5 mg (-1·64% [95% CI -1·78 to -1·50], -17·93 mmol/mol [-19·44 to -16·42]) and dulaglutide 0·75 mg (-1·59% [-1·73 to -1·45], -17·38 mmol/mol [-18·89 to -15·87]) than in those receiving glargine (-1·41% [-1·…
Summary
The adjusted mean difference versus glargine was -0·22% (95% CI -0·38 to -0·07, -2·40 mmol/mol [-4·15 to -0·77]; p=0·005) for dulaglutide 1·5 mg and -0·17% (-0·33 to -0·02, -1·86 mmol/mol [-3·61 to -0·22]; p=0·015) for dulaglutide 0·75 mg.
2 context sentences(design, population, supporting numbers)
Summary · context
We aimed to compare the efficacy and safety of long-acting glucagon-like peptide-1 receptor agonist dulaglutide with that of insulin glargine, both combined with prandial insulin lispro, in patients with type 2 diabetes.
Summary · context
Patients (aged ≥18 years) with type 2 diabetes inadequately controlled with conventional insulin treatment were randomly assigned (1:1:1), via a computer-generated randomisation sequence with an interactive voice-response system, to receive once-weekly dulaglutide 1·5 mg, dulaglutide 0·75 mg, or daily bedtime glargine.
Report a problemFND-2600922901
02HumanRandomized controlled trialEfficacy outcome
Dulaglutide 0·75 mg reduced HbA1c more than glargine at week 26 with background lispro.
In plain wordsWith lispro, dulaglutide 0·75 mg lowered HbA1c more than glargine at week 26.
Peptide
Dulaglutide (Trulicity)
Outcome
DecreaseHbA1c change
Study
n: not reported in source
Comparator
Insulin glargine with prandial insulin lispro
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
0·75 mg once weekly · 26 weeksAs given in this study (human).
Measurements
HbA1c change from baseline
−1.59%
dulaglutide 0·75 mg
HbA1c change from baseline
−1.41%
glargine
HbA1c adjusted mean difference versus glargine
−0.17%
dulaglutide 0·75 mg
Source sentences
Summary
At 26 weeks, the adjusted mean change in HbA1c was greater in patients receiving dulaglutide 1·5 mg (-1·64% [95% CI -1·78 to -1·50], -17·93 mmol/mol [-19·44 to -16·42]) and dulaglutide 0·75 mg (-1·59% [-1·73 to -1·45], -17·38 mmol/mol [-18·89 to -15·87]) than in those receiving glargine (-1·41% [-1·…
Summary
The adjusted mean difference versus glargine was -0·22% (95% CI -0·38 to -0·07, -2·40 mmol/mol [-4·15 to -0·77]; p=0·005) for dulaglutide 1·5 mg and -0·17% (-0·33 to -0·02, -1·86 mmol/mol [-3·61 to -0·22]; p=0·015) for dulaglutide 0·75 mg.
3 context sentences(design, population, supporting numbers)
Summary · context
and dulaglutide 0·75 mg (-1·59% [-1·73 to -1·45], -17·38 mmol/mol [-18·89 to -15·87]) than in those receiving glargine (-1·41% [-1·55 to -1·27], -15·41 mmol/mol [-16·92 to -13·90]).
Summary · context
We aimed to compare the efficacy and safety of long-acting glucagon-like peptide-1 receptor agonist dulaglutide with that of insulin glargine, both combined with prandial insulin lispro, in patients with type 2 diabetes.
Summary · context
Patients (aged ≥18 years) with type 2 diabetes inadequately controlled with conventional insulin treatment were randomly assigned (1:1:1), via a computer-generated randomisation sequence with an interactive voice-response system, to receive once-weekly dulaglutide 1·5 mg, dulaglutide 0·75 mg, or daily bedtime glargine.
Report a problemFND-2600922902
03HumanRandomized controlled trialSafety outcome
One patient in the dulaglutide 1·5 mg group died from septicaemia after randomisation.
In plain wordsOne patient receiving dulaglutide 1·5 mg died from septicaemia after randomisation.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableDeath from septicaemia
Study
n = 295
Outcome group
Mortality · Whole body
Studied dose
1·5 mg once weeklyAs given in this study (human).
Measurements
Deaths from septicaemia
1 patients
dulaglutide 1·5 mg group
Source sentences
Summary
Five (<1%) patients died after randomisation because of septicaemia (n=1 in the dulaglutide 1·5 mg group);
3 context sentences(design, population, supporting numbers)
Summary · context
Between Dec 9, 2010, and Sept 21, 2012, we randomly assigned 884 patients to receive dulaglutide 1·5 mg (n=295), dulaglutide 0·75 mg (n=293), or glargine (n=296).
Summary · context
We aimed to compare the efficacy and safety of long-acting glucagon-like peptide-1 receptor agonist dulaglutide with that of insulin glargine, both combined with prandial insulin lispro, in patients with type 2 diabetes.
Summary · context
Patients (aged ≥18 years) with type 2 diabetes inadequately controlled with conventional insulin treatment were randomly assigned (1:1:1), via a computer-generated randomisation sequence with an interactive voice-response system, to receive once-weekly dulaglutide 1·5 mg, dulaglutide 0·75 mg, or daily bedtime glargine.
Report a problemFND-2600922903
04HumanRandomized controlled trialSafety outcome
One patient in the dulaglutide 0·75 mg group died from pneumonia after randomisation.
In plain wordsOne patient receiving dulaglutide 0·75 mg died from pneumonia after randomisation.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableDeath from pneumonia
Study
n = 293
Outcome group
Mortality · Whole body
Studied dose
0·75 mg once weeklyAs given in this study (human).
Measurements
Deaths from pneumonia
1 patients
dulaglutide 0·75 mg group
Source sentences
Summary
pneumonia (n=1 in the dulaglutide 0·75 mg group);
3 context sentences(design, population, supporting numbers)
Summary · context
Between Dec 9, 2010, and Sept 21, 2012, we randomly assigned 884 patients to receive dulaglutide 1·5 mg (n=295), dulaglutide 0·75 mg (n=293), or glargine (n=296).
Summary · context
We aimed to compare the efficacy and safety of long-acting glucagon-like peptide-1 receptor agonist dulaglutide with that of insulin glargine, both combined with prandial insulin lispro, in patients with type 2 diabetes.
Summary · context
Patients (aged ≥18 years) with type 2 diabetes inadequately controlled with conventional insulin treatment were randomly assigned (1:1:1), via a computer-generated randomisation sequence with an interactive voice-response system, to receive once-weekly dulaglutide 1·5 mg, dulaglutide 0·75 mg, or daily bedtime glargine.
Report a problemFND-2600922904
05HumanRandomized controlled trialSafety outcome
Serious adverse events occurred in 9% with dulaglutide 1·5 mg versus 18% with glargine, both with lispro.
In plain wordsWith lispro, serious adverse events occurred in 9% with dulaglutide 1·5 mg versus 18% with glargine.
Peptide
Dulaglutide (Trulicity)
Outcome
DecreaseSerious adverse events
Study
n: not reported in source
Comparator
Insulin glargine with prandial insulin lispro
Outcome group
Adverse events · Whole body
Studied dose
1·5 mg once weeklyAs given in this study (human).
Measurements
Serious adverse events
27 patients
1·5 mg
Serious adverse events
9%
1·5 mg
Serious adverse events
54 patients
glargine
Serious adverse events
18%
glargine
Source sentences
Summary
We recorded serious adverse events in 27 (9%) patients in the dulaglutide 1·5 mg group, 44 (15%) patients in the dulaglutide 0·75 mg group, and 54 (18%) patients in the glargine group.
2 context sentences(design, population, supporting numbers)
Summary · context
We aimed to compare the efficacy and safety of long-acting glucagon-like peptide-1 receptor agonist dulaglutide with that of insulin glargine, both combined with prandial insulin lispro, in patients with type 2 diabetes.
Summary · context
Patients (aged ≥18 years) with type 2 diabetes inadequately controlled with conventional insulin treatment were randomly assigned (1:1:1), via a computer-generated randomisation sequence with an interactive voice-response system, to receive once-weekly dulaglutide 1·5 mg, dulaglutide 0·75 mg, or daily bedtime glargine.
Report a problemFND-2600922905
06HumanRandomized controlled trialSafety outcome
Serious adverse events occurred in 15% with dulaglutide 0·75 mg versus 18% with glargine, both with lispro.
In plain wordsWith lispro, serious adverse events occurred in 15% with dulaglutide 0·75 mg versus 18% with glargine.
Peptide
Dulaglutide (Trulicity)
Outcome
DecreaseSerious adverse events
Study
n: not reported in source
Comparator
Insulin glargine with prandial insulin lispro
Outcome group
Adverse events · Whole body
Studied dose
0·75 mg once weeklyAs given in this study (human).
Measurements
Serious adverse events
44 patients
0·75 mg
Serious adverse events
15%
0·75 mg
Serious adverse events
54 patients
glargine
Serious adverse events
18%
glargine
Source sentences
Summary
We recorded serious adverse events in 27 (9%) patients in the dulaglutide 1·5 mg group, 44 (15%) patients in the dulaglutide 0·75 mg group, and 54 (18%) patients in the glargine group.
2 context sentences(design, population, supporting numbers)
Summary · context
We aimed to compare the efficacy and safety of long-acting glucagon-like peptide-1 receptor agonist dulaglutide with that of insulin glargine, both combined with prandial insulin lispro, in patients with type 2 diabetes.
Summary · context
Patients (aged ≥18 years) with type 2 diabetes inadequately controlled with conventional insulin treatment were randomly assigned (1:1:1), via a computer-generated randomisation sequence with an interactive voice-response system, to receive once-weekly dulaglutide 1·5 mg, dulaglutide 0·75 mg, or daily bedtime glargine.
Report a problemFND-2600922906
07HumanRandomized controlled trialSafety outcome
Nausea occurred more often with dulaglutide than glargine, both with background lispro.
In plain wordsWith lispro, nausea occurred more often with dulaglutide than glargine.
Peptide
Dulaglutide (Trulicity)
Outcome
IncreaseNausea
Study
n: not reported in source
Comparator
Insulin glargine with prandial insulin lispro
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
Dose not stated
Source sentences
Summary
The most frequent adverse events, arising more often with dulaglutide than glargine, were nausea, diarrhoea, and vomiting.
2 context sentences(design, population, supporting numbers)
Summary · context
We aimed to compare the efficacy and safety of long-acting glucagon-like peptide-1 receptor agonist dulaglutide with that of insulin glargine, both combined with prandial insulin lispro, in patients with type 2 diabetes.
Summary · context
Patients (aged ≥18 years) with type 2 diabetes inadequately controlled with conventional insulin treatment were randomly assigned (1:1:1), via a computer-generated randomisation sequence with an interactive voice-response system, to receive once-weekly dulaglutide 1·5 mg, dulaglutide 0·75 mg, or daily bedtime glargine.
Report a problemFND-2600922907
08HumanRandomized controlled trialSafety outcome
Diarrhoea occurred more often with dulaglutide than glargine, both with background lispro.
In plain wordsWith lispro, diarrhoea occurred more often with dulaglutide than glargine.
Peptide
Dulaglutide (Trulicity)
Outcome
IncreaseDiarrhoea
Study
n: not reported in source
Comparator
Insulin glargine with prandial insulin lispro
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
Dose not stated
Source sentences
Summary
The most frequent adverse events, arising more often with dulaglutide than glargine, were nausea, diarrhoea, and vomiting.
2 context sentences(design, population, supporting numbers)
Summary · context
We aimed to compare the efficacy and safety of long-acting glucagon-like peptide-1 receptor agonist dulaglutide with that of insulin glargine, both combined with prandial insulin lispro, in patients with type 2 diabetes.
Summary · context
Patients (aged ≥18 years) with type 2 diabetes inadequately controlled with conventional insulin treatment were randomly assigned (1:1:1), via a computer-generated randomisation sequence with an interactive voice-response system, to receive once-weekly dulaglutide 1·5 mg, dulaglutide 0·75 mg, or daily bedtime glargine.
Report a problemFND-2600922908
09HumanRandomized controlled trialSafety outcome
Vomiting occurred more often with dulaglutide than glargine, both with background lispro.
In plain wordsWith lispro, vomiting occurred more often with dulaglutide than glargine.
Peptide
Dulaglutide (Trulicity)
Outcome
IncreaseVomiting
Study
n: not reported in source
Comparator
Insulin glargine with prandial insulin lispro
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
Dose not stated
Source sentences
Summary
The most frequent adverse events, arising more often with dulaglutide than glargine, were nausea, diarrhoea, and vomiting.
2 context sentences(design, population, supporting numbers)
Summary · context
We aimed to compare the efficacy and safety of long-acting glucagon-like peptide-1 receptor agonist dulaglutide with that of insulin glargine, both combined with prandial insulin lispro, in patients with type 2 diabetes.
Summary · context
Patients (aged ≥18 years) with type 2 diabetes inadequately controlled with conventional insulin treatment were randomly assigned (1:1:1), via a computer-generated randomisation sequence with an interactive voice-response system, to receive once-weekly dulaglutide 1·5 mg, dulaglutide 0·75 mg, or daily bedtime glargine.
Report a problemFND-2600922909

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 postedNCT01191268

A Study in Participants With Type 2 Diabetes Mellitus (AWARD-4)

Eli Lilly and Companyn = 884Nov 2010 to Sept 2012

Diabetes Mellitus, Type 2

Trial page ClinicalTrials.govUpdated 8 Oct 2014

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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