Continuous glucose monitoring in patients with type 2 diabetes treated with glucagon-like peptide-1 receptor agonist dulaglutide in combination with prandial insulin lispro: an AWARD-4 substudy.

Jendle J, Testa MA, Martin S, Jiang H, Milicevic Z

Diabetes, obesity & metabolism22 Jul 2016Cited by 29 (Europe PMC)

PMID27279266DOI10.1111/dom.12705PepBankPUB-27279266

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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 study10

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

01HumanRandomized controlled trialEfficacy outcome
Time in the 3.9-7.8 mmol/L glucose range was similar across dulaglutide and glargine groups receiving lispro.
In plain wordsWith lispro, time in the target glucose range was similar with dulaglutide and glargine.
Peptide
Dulaglutide (Trulicity)
Outcome
No significant changeTime in normoglycaemic range
Study
n = 144
Comparator
Insulin glargine with prandial insulin lispro
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
Dose not stated · 26 weeksAs given in this study (human).
Source sentences
Summary
Treatment groups were similar for percentage time in the 3.9-7.8 mmol/L range.
2 context sentences(design, population, supporting numbers)
Summary · context
The primary objective was treatment comparison for percentage time spent with CGM glucose values in the 3.9-7.8 mmol/L range after 26 weeks.
Summary · context
The AWARD-4 trial randomized 884 conventional insulin regimen-treated patients to dulaglutide 1.5 mg, dulaglutide 0.75 mg and glargine, all in combination with prandial insulin lispro. The CGM substudy included 144 patients inserted with a Medtronic CGMS iPro CGM device to enable 3-day glucose monitoring.
Report a problemFND-2727926603
02HumanRandomized controlled trialEfficacy outcome
Normoglycaemia measures did not differ significantly across dulaglutide and glargine groups receiving lispro at week 52.
In plain wordsWith lispro, normal glucose measures did not differ significantly between dulaglutide and glargine at week 52.
Peptide
Dulaglutide (Trulicity)
Outcome
No significant changeNormoglycaemia measures
Study
n = 144
Comparator
Insulin glargine with prandial insulin lispro
Outcome group
Glycemic control · Metabolic and weight
Studied dose
Dose not stated · 52 weeksAs given in this study (human).
Source sentences
Summary
At week 52, there were no significant differences among the groups with regard to measures of normoglycaemia or near-normoglycaemia and for the overall within-patient s.d.
1 context sentence(design, population, supporting numbers)
Summary · context
The AWARD-4 trial randomized 884 conventional insulin regimen-treated patients to dulaglutide 1.5 mg, dulaglutide 0.75 mg and glargine, all in combination with prandial insulin lispro. The CGM substudy included 144 patients inserted with a Medtronic CGMS iPro CGM device to enable 3-day glucose monitoring.
Report a problemFND-2727926607
03HumanRandomized controlled trialEfficacy outcome
Near-normoglycaemia measures did not differ significantly across dulaglutide and glargine groups receiving lispro at week 52.
In plain wordsWith lispro, near-normal glucose measures did not differ significantly between dulaglutide and glargine at week 52.
Peptide
Dulaglutide (Trulicity)
Outcome
No significant changeNear-normoglycaemia measures
Study
n = 144
Comparator
Insulin glargine with prandial insulin lispro
Outcome group
Glycemic control · Metabolic and weight
Studied dose
Dose not stated · 52 weeksAs given in this study (human).
Source sentences
Summary
At week 52, there were no significant differences among the groups with regard to measures of normoglycaemia or near-normoglycaemia and for the overall within-patient s.d.
1 context sentence(design, population, supporting numbers)
Summary · context
The AWARD-4 trial randomized 884 conventional insulin regimen-treated patients to dulaglutide 1.5 mg, dulaglutide 0.75 mg and glargine, all in combination with prandial insulin lispro. The CGM substudy included 144 patients inserted with a Medtronic CGMS iPro CGM device to enable 3-day glucose monitoring.
Report a problemFND-2727926608
04HumanRandomized controlled trialEfficacy outcome
Overall within-patient glucose standard deviation did not differ significantly across dulaglutide and glargine groups receiving lispro at week 52.
In plain wordsWith lispro, glucose variation within patients did not differ significantly between dulaglutide and glargine at week 52.
Peptide
Dulaglutide (Trulicity)
Outcome
No significant changeWithin-patient glucose standard deviation
Study
n = 144
Comparator
Insulin glargine with prandial insulin lispro
Outcome group
Glycemic control · Metabolic and weight
Studied dose
Dose not stated · 52 weeksAs given in this study (human).
Source sentences
Summary
At week 52, there were no significant differences among the groups with regard to measures of normoglycaemia or near-normoglycaemia and for the overall within-patient s.d.
1 context sentence(design, population, supporting numbers)
Summary · context
The AWARD-4 trial randomized 884 conventional insulin regimen-treated patients to dulaglutide 1.5 mg, dulaglutide 0.75 mg and glargine, all in combination with prandial insulin lispro. The CGM substudy included 144 patients inserted with a Medtronic CGMS iPro CGM device to enable 3-day glucose monitoring.
Report a problemFND-2727926609
05HumanRandomized controlled trialSafety outcome
Time at glucose values at or below 3.9 mmol/L increased less with dulaglutide than glargine with background lispro at week 52.
In plain wordsWith lispro, time with low glucose increased less with dulaglutide than glargine at week 52.
Peptide
Dulaglutide (Trulicity)
Outcome
DecreaseTime in hypoglycaemic range
Study
n = 144
Comparator
Insulin glargine with prandial insulin lispro
Outcome group
Adverse events · Metabolic and weight
Studied dose
Dose not stated · 52 weeksAs given in this study (human).
Source sentences
Summary
Treatment with glargine was associated with greater increases in percentage time spent with glucose values ≤3.9 mmol/L, with statistically significant differences between the groups at 52 weeks (p < 0.05).
1 context sentence(design, population, supporting numbers)
Summary · context
The AWARD-4 trial randomized 884 conventional insulin regimen-treated patients to dulaglutide 1.5 mg, dulaglutide 0.75 mg and glargine, all in combination with prandial insulin lispro. The CGM substudy included 144 patients inserted with a Medtronic CGMS iPro CGM device to enable 3-day glucose monitoring.
Report a problemFND-2727926610
06HumanRandomized controlled trialEfficacy outcome
Mean 24-hour CGM glucose fell from baseline in all groups at week 26, and the difference between dulaglutide 1.5 mg and glargine was not significant (all with lispro).
In plain wordsWith lispro, average glucose fell in every group, and dulaglutide 1.5 mg did not differ significantly from glargine.
Peptide
Dulaglutide (Trulicity)
Outcome
No significant changeMean CGM glucose
Study
n: not reported in source
Comparator
Insulin glargine with prandial insulin lispro
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1.5 mg · 26 weeksAs given in this study (human).
Measurements
Glucose change
−2.8 mmol/L
dulaglutide 1.5 mg
Glucose change
−2.5 mmol/L
insulin glargine with prandial insulin lispro
Source sentences
Summary
At week 26, mean CGM values decreased in all treatment groups (change from baseline -2.8 ± 0.3, -2.4 ± 0.3 and -2.5 ± 0.3 mmol/L for dulaglutide 1.5 mg, dulaglutide 0.75 mg and glargine, respectively); between-group differences were not statistically significant.
1 context sentence(design, population, supporting numbers)
Summary · context
The AWARD-4 trial randomized 884 conventional insulin regimen-treated patients to dulaglutide 1.5 mg, dulaglutide 0.75 mg and glargine, all in combination with prandial insulin lispro. The CGM substudy included 144 patients inserted with a Medtronic CGMS iPro CGM device to enable 3-day glucose monitoring.
Report a problemFND-2727926601
07HumanRandomized controlled trialEfficacy outcome
Mean 24-hour CGM glucose fell from baseline in all groups at week 26, and the difference between dulaglutide 0.75 mg and glargine was not significant (all with lispro).
In plain wordsWith lispro, average glucose fell in every group, and dulaglutide 0.75 mg did not differ significantly from glargine.
Peptide
Dulaglutide (Trulicity)
Outcome
No significant changeMean CGM glucose
Study
n: not reported in source
Comparator
Insulin glargine with prandial insulin lispro
Outcome group
Glycemic control · Metabolic and weight
Studied dose
0.75 mg · 26 weeksAs given in this study (human).
Measurements
Glucose change
−2.4 mmol/L
dulaglutide 0.75 mg
Glucose change
−2.5 mmol/L
insulin glargine with prandial insulin lispro
Source sentences
Summary
At week 26, mean CGM values decreased in all treatment groups (change from baseline -2.8 ± 0.3, -2.4 ± 0.3 and -2.5 ± 0.3 mmol/L for dulaglutide 1.5 mg, dulaglutide 0.75 mg and glargine, respectively); between-group differences were not statistically significant.
1 context sentence(design, population, supporting numbers)
Summary · context
The AWARD-4 trial randomized 884 conventional insulin regimen-treated patients to dulaglutide 1.5 mg, dulaglutide 0.75 mg and glargine, all in combination with prandial insulin lispro. The CGM substudy included 144 patients inserted with a Medtronic CGMS iPro CGM device to enable 3-day glucose monitoring.
Report a problemFND-2727926602
08HumanRandomized controlled trialEfficacy outcome
Dulaglutide 1.5 mg increased time in the 3.9-10.0 mmol/L glucose range versus glargine with background lispro.
In plain wordsWith lispro, dulaglutide 1.5 mg increased time near the target glucose range versus glargine.
Peptide
Dulaglutide (Trulicity)
Outcome
IncreaseTime in near-normoglycaemic range
Study
n: not reported in source
Comparator
Insulin glargine with prandial insulin lispro
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1.5 mgAs given in this study (human).
Source sentences
Summary
Percentage time in the 3.9-10.0 mmol/L range was greater for dulaglutide 1.5 mg than for glargine (p < 0.05).
1 context sentence(design, population, supporting numbers)
Summary · context
The AWARD-4 trial randomized 884 conventional insulin regimen-treated patients to dulaglutide 1.5 mg, dulaglutide 0.75 mg and glargine, all in combination with prandial insulin lispro. The CGM substudy included 144 patients inserted with a Medtronic CGMS iPro CGM device to enable 3-day glucose monitoring.
Report a problemFND-2727926604
09HumanRandomized controlled trialEfficacy outcome
Dulaglutide 1.5 mg reduced overall within-patient glucose standard deviation versus glargine with background lispro.
In plain wordsWith lispro, glucose varied less within patients receiving dulaglutide 1.5 mg than glargine.
Peptide
Dulaglutide (Trulicity)
Outcome
DecreaseWithin-patient glucose standard deviation
Study
n: not reported in source
Comparator
Insulin glargine with prandial insulin lispro
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1.5 mgAs given in this study (human).
Source sentences
Summary
The overall within-patient standard deviation (s.d.) was significantly reduced with dulaglutide 1.5 mg versus glargine (p < 0.05).
1 context sentence(design, population, supporting numbers)
Summary · context
The AWARD-4 trial randomized 884 conventional insulin regimen-treated patients to dulaglutide 1.5 mg, dulaglutide 0.75 mg and glargine, all in combination with prandial insulin lispro. The CGM substudy included 144 patients inserted with a Medtronic CGMS iPro CGM device to enable 3-day glucose monitoring.
Report a problemFND-2727926606

Studies that did not test the peptide alone1

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).

10HumanNot a test of Dulaglutide (Trulicity) aloneRandomized controlled trialEfficacy outcome
Glucose variability decreased with both dulaglutide and glargine regimens that included lispro.
In plain wordsGlucose variation fell with both dulaglutide and glargine regimens that included lispro.
Peptide
Dulaglutide (Trulicity)
Outcome
DecreaseCGM variability indices
Study
n = 144
Outcome group
Glycemic control · Metabolic and weight
Source sentences
Summary
Dulaglutide and glargine were associated with decreased glucose variability for all CGM variability indices.
1 context sentence(design, population, supporting numbers)
Summary · context
The AWARD-4 trial randomized 884 conventional insulin regimen-treated patients to dulaglutide 1.5 mg, dulaglutide 0.75 mg and glargine, all in combination with prandial insulin lispro. The CGM substudy included 144 patients inserted with a Medtronic CGMS iPro CGM device to enable 3-day glucose monitoring.
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-2727926605

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, 02:26 UTC
Study results updated
Version 1
21 Oct 2026, 18:59 UTC
First added · source update from Europe PMC

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Continuous glucose monitoring in patients with type 2 diabetes treated with glucagon-like peptide-1 receptor agonist dulaglutide in combination with prandial insulin lispro: an AWARD-4 substudy.

Summary

Results from this study10

Studies that did not test the peptide alone1

Version history

Subjects

Publication types

MeSH terms

Keywords