Glycaemic efficacy of an expanded dose range of dulaglutide according to baseline glycated haemoglobin (HbA1c) subgroup: Post hoc analysis of AWARD-11.

Frias JP, Bonora E, Cox DA, Bethel MA, Kwan AYM, Raha S, Malik RE

Diabetes, obesity & metabolism14 Sept 2021Cited by 6 (Europe PMC)

PMID34463420PMCIDPMC9292947DOI10.1111/dom.14533PepBankPUB-34463420

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

Results from this study10

7 results from studies that gave the peptide. 7 results from people.

01HumanRandomized controlled trialEfficacy outcome
In patients with type 2 diabetes, dulaglutide 1.5 mg reduced HbA1c across baseline HbA1c subgroups at 36 weeks.
In plain wordsIn patients with diabetes, dulaglutide 1.5 mg reduced HbA1c from baseline across starting HbA1c subgroups at 36 weeks.
Peptide
Dulaglutide (Trulicity)
Outcome
DecreaseHbA1c reduction range at 36 weeks
Study
n: not reported in source
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1.5 mg · 36 weeksAs given in this study (human).
Measurements
HbA1c change
−2.2 to −1%
1.5 mg across baseline subgroups
Source sentences
Summary
Mean reductions in HbA1c were observed across all baseline HbA1c subgroups at 36 weeks (range of HbA1c change: 1.5 mg: -1.0% to -2.2%; 3.0 mg: -1.2% to -2.5%; and 4.5 mg: -1.2% to -3.2%).
2 context sentences(design, population, supporting numbers)
Summary · context
The AWARD-11 trial demonstrated the safety and efficacy of dulaglutide 3.0 and 4.5 mg compared to dulaglutide 1.5 mg in patients with type 2 diabetes inadequately controlled with metformin.
Summary · context
This post hoc analysis examined the change from baseline in glycated haemoglobin (HbA1c) and proportions of patients achieving HbA1c <7% at weeks 36 and 52 with dulaglutide 1.5 mg, 3.0 mg or 4.5 mg across clinically relevant baseline HbA1c subgroups (<8%; 8.0% to < 9.0%; 9.0% to < 10%; and ≥ 10%).
Report a problemFND-3446342001
02HumanRandomized controlled trialEfficacy outcome
In patients with type 2 diabetes, dulaglutide 3.0 mg reduced HbA1c across baseline HbA1c subgroups at 36 weeks.
In plain wordsIn patients with diabetes, dulaglutide 3.0 mg reduced HbA1c from baseline across starting HbA1c subgroups at 36 weeks.
Peptide
Dulaglutide (Trulicity)
Outcome
DecreaseHbA1c reduction range at 36 weeks
Study
n: not reported in source
Outcome group
Glycemic control · Metabolic and weight
Studied dose
3.0 mg · 36 weeksAs given in this study (human).
Measurements
HbA1c change
−2.5 to −1.2%
3.0 mg across baseline subgroups
Source sentences
Summary
Mean reductions in HbA1c were observed across all baseline HbA1c subgroups at 36 weeks (range of HbA1c change: 1.5 mg: -1.0% to -2.2%; 3.0 mg: -1.2% to -2.5%; and 4.5 mg: -1.2% to -3.2%).
2 context sentences(design, population, supporting numbers)
Summary · context
The AWARD-11 trial demonstrated the safety and efficacy of dulaglutide 3.0 and 4.5 mg compared to dulaglutide 1.5 mg in patients with type 2 diabetes inadequately controlled with metformin.
Summary · context
This post hoc analysis examined the change from baseline in glycated haemoglobin (HbA1c) and proportions of patients achieving HbA1c <7% at weeks 36 and 52 with dulaglutide 1.5 mg, 3.0 mg or 4.5 mg across clinically relevant baseline HbA1c subgroups (<8%; 8.0% to < 9.0%; 9.0% to < 10%; and ≥ 10%).
Report a problemFND-3446342002
03HumanRandomized controlled trialEfficacy outcome
In patients with type 2 diabetes, dulaglutide 4.5 mg reduced HbA1c across baseline HbA1c subgroups at 36 weeks.
In plain wordsIn patients with diabetes, dulaglutide 4.5 mg reduced HbA1c from baseline across starting HbA1c subgroups at 36 weeks.
Peptide
Dulaglutide (Trulicity)
Outcome
DecreaseHbA1c reduction range at 36 weeks
Study
n: not reported in source
Outcome group
Glycemic control · Metabolic and weight
Studied dose
4.5 mg · 36 weeksAs given in this study (human).
Measurements
HbA1c change
−3.2 to −1.2%
4.5 mg across baseline subgroups
Source sentences
Summary
Mean reductions in HbA1c were observed across all baseline HbA1c subgroups at 36 weeks (range of HbA1c change: 1.5 mg: -1.0% to -2.2%; 3.0 mg: -1.2% to -2.5%; and 4.5 mg: -1.2% to -3.2%).
2 context sentences(design, population, supporting numbers)
Summary · context
The AWARD-11 trial demonstrated the safety and efficacy of dulaglutide 3.0 and 4.5 mg compared to dulaglutide 1.5 mg in patients with type 2 diabetes inadequately controlled with metformin.
Summary · context
This post hoc analysis examined the change from baseline in glycated haemoglobin (HbA1c) and proportions of patients achieving HbA1c <7% at weeks 36 and 52 with dulaglutide 1.5 mg, 3.0 mg or 4.5 mg across clinically relevant baseline HbA1c subgroups (<8%; 8.0% to < 9.0%; 9.0% to < 10%; and ≥ 10%).
Report a problemFND-3446342003
04HumanRandomized controlled trialEfficacy outcome
In patients with type 2 diabetes, more patients achieved HbA1c below 7% with dulaglutide 3.0 mg than 1.5 mg across baseline subgroups.
In plain wordsIn patients with diabetes, more patients reached HbA1c below 7% with dulaglutide 3.0 mg than 1.5 mg across starting subgroups.
Peptide
Dulaglutide (Trulicity)
Outcome
IncreaseHbA1c target attainment at 36 weeks
Study
n: not reported in source
Comparator
Dulaglutide 1.5 mg
Outcome group
Glycemic control · Metabolic and weight
Studied dose
3.0 mg · 36 weeksAs given in this study (human).
Source sentences
Summary
More patients randomized to 3.0 mg or 4.5 mg (vs. 1.5 mg) achieved HbA1c <7% at 36 weeks regardless of baseline HbA1c; the difference in proportions was greater at higher baseline HbA1c (P-interaction = 0.096).
2 context sentences(design, population, supporting numbers)
Summary · context
The AWARD-11 trial demonstrated the safety and efficacy of dulaglutide 3.0 and 4.5 mg compared to dulaglutide 1.5 mg in patients with type 2 diabetes inadequately controlled with metformin.
Summary · context
This post hoc analysis examined the change from baseline in glycated haemoglobin (HbA1c) and proportions of patients achieving HbA1c <7% at weeks 36 and 52 with dulaglutide 1.5 mg, 3.0 mg or 4.5 mg across clinically relevant baseline HbA1c subgroups (<8%; 8.0% to < 9.0%; 9.0% to < 10%; and ≥ 10%).
Report a problemFND-3446342004
05HumanRandomized controlled trialEfficacy outcome
In patients with type 2 diabetes, more patients achieved HbA1c below 7% with dulaglutide 4.5 mg than 1.5 mg across baseline subgroups.
In plain wordsIn patients with diabetes, more patients reached HbA1c below 7% with dulaglutide 4.5 mg than 1.5 mg across starting subgroups.
Peptide
Dulaglutide (Trulicity)
Outcome
IncreaseHbA1c target attainment at 36 weeks
Study
n: not reported in source
Comparator
Dulaglutide 1.5 mg
Outcome group
Glycemic control · Metabolic and weight
Studied dose
4.5 mg · 36 weeksAs given in this study (human).
Source sentences
Summary
More patients randomized to 3.0 mg or 4.5 mg (vs. 1.5 mg) achieved HbA1c <7% at 36 weeks regardless of baseline HbA1c; the difference in proportions was greater at higher baseline HbA1c (P-interaction = 0.096).
2 context sentences(design, population, supporting numbers)
Summary · context
The AWARD-11 trial demonstrated the safety and efficacy of dulaglutide 3.0 and 4.5 mg compared to dulaglutide 1.5 mg in patients with type 2 diabetes inadequately controlled with metformin.
Summary · context
This post hoc analysis examined the change from baseline in glycated haemoglobin (HbA1c) and proportions of patients achieving HbA1c <7% at weeks 36 and 52 with dulaglutide 1.5 mg, 3.0 mg or 4.5 mg across clinically relevant baseline HbA1c subgroups (<8%; 8.0% to < 9.0%; 9.0% to < 10%; and ≥ 10%).
Report a problemFND-3446342005
06HumanRandomized controlled trialEfficacy outcome
In patients with type 2 diabetes, the pattern of glycemic improvement across dulaglutide doses and baseline HbA1c subgroups at 52 weeks was similar to that at 36 weeks.
In plain wordsIn patients with diabetes, blood sugar improvement with dulaglutide at 52 weeks followed a pattern similar to the pattern at 36 weeks.
Peptide
Dulaglutide (Trulicity)
Outcome
DecreaseGlycemic improvement at 52 weeks
Study
n: not reported in source
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1.5 mg, 3.0 mg or 4.5 mg · 52 weeksAs given in this study (human).
Source sentences
Summary
Similar patterns in glycaemic improvement and proportions achieving HbA1c <7% were observed at 52 weeks.
3 context sentences(design, population, supporting numbers)
Summary · context
Mean reductions in HbA1c were observed across all baseline HbA1c subgroups at 36 weeks (range of HbA1c change: 1.5 mg: -1.0% to -2.2%; 3.0 mg: -1.2% to -2.5%; and 4.5 mg: -1.2% to -3.2%).
Summary · context
The AWARD-11 trial demonstrated the safety and efficacy of dulaglutide 3.0 and 4.5 mg compared to dulaglutide 1.5 mg in patients with type 2 diabetes inadequately controlled with metformin.
Summary · context
This post hoc analysis examined the change from baseline in glycated haemoglobin (HbA1c) and proportions of patients achieving HbA1c <7% at weeks 36 and 52 with dulaglutide 1.5 mg, 3.0 mg or 4.5 mg across clinically relevant baseline HbA1c subgroups (<8%; 8.0% to < 9.0%; 9.0% to < 10%; and ≥ 10%).
Report a problemFND-3446342007
07HumanRandomized controlled trialEfficacy outcome
In patients with type 2 diabetes, the pattern of HbA1c below 7% attainment at 52 weeks was similar to that at 36 weeks, when more patients reached it with dulaglutide 3.0 mg or 4.5 mg than with 1.5 mg.
In plain wordsThe 52-week HbA1c goal pattern resembled week 36, when higher dulaglutide doses performed better than 1.5 mg in patients with diabetes.
Peptide
Dulaglutide (Trulicity)
Outcome
IncreaseHbA1c target attainment at 52 weeks
Study
n: not reported in source
Comparator
Dulaglutide 1.5 mg
Outcome group
Glycemic control · Metabolic and weight
Studied dose
3.0 mg or 4.5 mg versus 1.5 mg · 52 weeksAs given in this study (human).
Source sentences
Summary
Similar patterns in glycaemic improvement and proportions achieving HbA1c <7% were observed at 52 weeks.
3 context sentences(design, population, supporting numbers)
Summary · context
More patients randomized to 3.0 mg or 4.5 mg (vs. 1.5 mg) achieved HbA1c <7% at 36 weeks regardless of baseline HbA1c; the difference in proportions was greater at higher baseline HbA1c (P-interaction = 0.096).
Summary · context
The AWARD-11 trial demonstrated the safety and efficacy of dulaglutide 3.0 and 4.5 mg compared to dulaglutide 1.5 mg in patients with type 2 diabetes inadequately controlled with metformin.
Summary · context
This post hoc analysis examined the change from baseline in glycated haemoglobin (HbA1c) and proportions of patients achieving HbA1c <7% at weeks 36 and 52 with dulaglutide 1.5 mg, 3.0 mg or 4.5 mg across clinically relevant baseline HbA1c subgroups (<8%; 8.0% to < 9.0%; 9.0% to < 10%; and ≥ 10%).
Report a problemFND-3446342008

Studies that did not test the peptide alone3

In this study, Dulaglutide (Trulicity) was a lab tool or a carrier, part of a mix, or the subject of a lab method. These results are not evidence about taking Dulaglutide (Trulicity).

08HumanNot a test of Dulaglutide (Trulicity) aloneObservational studyEfficacy outcome
In patients with type 2 diabetes, the difference in the proportion reaching HbA1c below 7% at 36 weeks with dulaglutide 3.0 mg or 4.5 mg versus 1.5 mg was greater at higher baseline HbA1c (P-interaction = 0.096).
In plain wordsIn patients with diabetes, the gain from higher dulaglutide doses in reaching the HbA1c goal was larger at higher starting HbA1c (interaction P = 0.096).
Peptide
Dulaglutide (Trulicity)
Outcome
IncreaseBaseline HbA1c interaction with target attainment difference
Study
n: not reported in source
Comparator
Dulaglutide 1.5 mg
Outcome group
Glycemic control · Metabolic and weight
Measurements
Interaction P value
0.096 P
baseline HbA1c
Source sentences
Summary
More patients randomized to 3.0 mg or 4.5 mg (vs. 1.5 mg) achieved HbA1c <7% at 36 weeks regardless of baseline HbA1c; the difference in proportions was greater at higher baseline HbA1c (P-interaction = 0.096).
2 context sentences(design, population, supporting numbers)
Summary · context
The AWARD-11 trial demonstrated the safety and efficacy of dulaglutide 3.0 and 4.5 mg compared to dulaglutide 1.5 mg in patients with type 2 diabetes inadequately controlled with metformin.
Summary · context
This post hoc analysis examined the change from baseline in glycated haemoglobin (HbA1c) and proportions of patients achieving HbA1c <7% at weeks 36 and 52 with dulaglutide 1.5 mg, 3.0 mg or 4.5 mg across clinically relevant baseline HbA1c subgroups (<8%; 8.0% to < 9.0%; 9.0% to < 10%; and ≥ 10%).
In this study, Dulaglutide (Trulicity) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Dulaglutide (Trulicity).
Report a problemFND-3446342006
09HumanNot a test of Dulaglutide (Trulicity) aloneObservational studySafety outcome
In patients with type 2 diabetes receiving dulaglutide, hypoglycaemia was similar across baseline HbA1c subgroups.
In plain wordsIn patients with diabetes receiving dulaglutide, low blood sugar events were similar across starting HbA1c subgroups.
Peptide
Dulaglutide (Trulicity)
Outcome
No significant changeHypoglycaemia across baseline HbA1c subgroups
Study
n: not reported in source
Comparator
Baseline HbA1c subgroups
Outcome group
Adverse events · Metabolic and weight
Source sentences
Summary
Hypoglycaemia and gastrointestinal adverse events were similar among the HbA1c subgroups.
2 context sentences(design, population, supporting numbers)
Summary · context
The AWARD-11 trial demonstrated the safety and efficacy of dulaglutide 3.0 and 4.5 mg compared to dulaglutide 1.5 mg in patients with type 2 diabetes inadequately controlled with metformin.
Summary · context
This post hoc analysis examined the change from baseline in glycated haemoglobin (HbA1c) and proportions of patients achieving HbA1c <7% at weeks 36 and 52 with dulaglutide 1.5 mg, 3.0 mg or 4.5 mg across clinically relevant baseline HbA1c subgroups (<8%; 8.0% to < 9.0%; 9.0% to < 10%; and ≥ 10%).
In this study, Dulaglutide (Trulicity) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Dulaglutide (Trulicity).
Report a problemFND-3446342009
10HumanNot a test of Dulaglutide (Trulicity) aloneObservational studySafety outcome
In patients with type 2 diabetes receiving dulaglutide, gastrointestinal adverse events were similar across baseline HbA1c subgroups.
In plain wordsIn patients with diabetes receiving dulaglutide, digestive adverse events were similar across starting HbA1c subgroups.
Peptide
Dulaglutide (Trulicity)
Outcome
No significant changeGastrointestinal adverse events across baseline HbA1c subgroups
Study
n: not reported in source
Comparator
Baseline HbA1c subgroups
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Source sentences
Summary
Hypoglycaemia and gastrointestinal adverse events were similar among the HbA1c subgroups.
2 context sentences(design, population, supporting numbers)
Summary · context
The AWARD-11 trial demonstrated the safety and efficacy of dulaglutide 3.0 and 4.5 mg compared to dulaglutide 1.5 mg in patients with type 2 diabetes inadequately controlled with metformin.
Summary · context
This post hoc analysis examined the change from baseline in glycated haemoglobin (HbA1c) and proportions of patients achieving HbA1c <7% at weeks 36 and 52 with dulaglutide 1.5 mg, 3.0 mg or 4.5 mg across clinically relevant baseline HbA1c subgroups (<8%; 8.0% to < 9.0%; 9.0% to < 10%; and ≥ 10%).
In this study, Dulaglutide (Trulicity) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Dulaglutide (Trulicity).
Report a problemFND-3446342010

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

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

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