Exenatide twice daily versus premixed insulin aspart 70/30 in metformin-treated patients with type 2 diabetes: a randomized 26-week study on glycemic control and hypoglycemia.

Gallwitz B, Böhmer M, Segiet T, Mölle A, Milek K, Becker B, Helsberg K, Petto H, Peters N, Bachmann O

Diabetes care1 Feb 2011Cited by 78 (Europe PMC)

PMID21285388PMCIDPMC3041190DOI10.2337/dc10-1900PepBankPUB-21285388

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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 study4

4 results from studies that gave the peptide. 4 results from people.

01HumanRandomized controlled trialEfficacy outcome
In metformin-treated T2D patients, exenatide was noninferior to premixed insulin aspart for A1C control.
In plain wordsIn metformin-treated T2D patients, exenatide met the noninferiority criterion for A1C control compared with premixed insulin aspart.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableA1C control
Study
n = 354
Comparator
Premixed insulin aspart 70/30
Outcome group
Glycemic control · Metabolic and weight
Studied dose
5 μg twice daily for 4 weeks, then 10 μg twice daily · 26 weeksAs given in this study (human).
Measurements
A1C change
−1%
exenatide
A1C change
−1.14%
insulin
Difference
0.14%
exenatide versus insulin
Source sentences
Summary
Exenatide BID (n = 181) was noninferior to PIA (n = 173) for A1C control (least squares [LS] mean change -1.0 vs. -1.14%; difference [95% CI] 0.14 [-0.003 to 0.291]) and associated with a lower risk for hypoglycemia (8.0 vs. 20.5%, P < 0.05).
1 context sentence(design, population, supporting numbers)
Summary · context
In this open-label study, metformin-treated adults with type 2 diabetes were randomized to 26-week treatment with exenatide BID (4 weeks 5 μg, then 10 μg) or PIA.
Report a problemFND-2128538801
02HumanRandomized controlled trialSafety outcome
In metformin-treated T2D patients, exenatide reduced hypoglycemia risk versus premixed insulin aspart.
In plain wordsIn metformin-treated T2D patients, exenatide caused less low blood sugar than premixed insulin aspart.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseHypoglycemia
Study
n = 354
Comparator
Premixed insulin aspart 70/30
Outcome group
Adverse events · Metabolic and weight
Studied dose
5 μg twice daily for 4 weeks, then 10 μg twice daily · 26 weeksAs given in this study (human).
Measurements
Hypoglycemia
8%
exenatide
Hypoglycemia
20.5%
insulin
Source sentences
Summary
Exenatide BID (n = 181) was noninferior to PIA (n = 173) for A1C control (least squares [LS] mean change -1.0 vs. -1.14%; difference [95% CI] 0.14 [-0.003 to 0.291]) and associated with a lower risk for hypoglycemia (8.0 vs. 20.5%, P < 0.05).
1 context sentence(design, population, supporting numbers)
Summary · context
In this open-label study, metformin-treated adults with type 2 diabetes were randomized to 26-week treatment with exenatide BID (4 weeks 5 μg, then 10 μg) or PIA.
Report a problemFND-2128538802
03HumanRandomized controlled trialEfficacy outcome
In metformin-treated T2D patients, weight fell with exenatide but increased with premixed insulin aspart.
In plain wordsIn metformin-treated T2D patients, weight fell with exenatide but increased with premixed insulin aspart.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseBody weight
Study
n = 354
Comparator
Premixed insulin aspart 70/30
Outcome group
Body weight · Metabolic and weight
Studied dose
5 μg twice daily for 4 weeks, then 10 μg twice daily · 26 weeksAs given in this study (human).
Measurements
Weight reduction
4.1 kg
exenatide
Weight increase
1 kg
insulin
Source sentences
Summary
LS mean weight decreased by 4.1 kg and increased by 1.0 kg with PIA (P < 0.001).
1 context sentence(design, population, supporting numbers)
Summary · context
In this open-label study, metformin-treated adults with type 2 diabetes were randomized to 26-week treatment with exenatide BID (4 weeks 5 μg, then 10 μg) or PIA.
Report a problemFND-2128538803
04HumanRandomized controlled trialEfficacy outcome
In metformin-treated T2D patients, more exenatide patients achieved A1C <7.0%, no weight gain and no hypoglycemia than insulin patients.
In plain wordsIn T2D patients, more exenatide patients met the combined blood sugar, weight and hypoglycemia target than insulin patients.
Peptide
Exenatide (exendin-4)
Outcome
IncreaseComposite A1C, weight and hypoglycemia response
Study
n = 354
Comparator
Premixed insulin aspart 70/30
Outcome group
Glycemic control · Metabolic and weight
Studied dose
5 μg twice daily for 4 weeks, then 10 μg twice daily · 26 weeksAs given in this study (human).
Measurements
Composite response
39.2%
exenatide
Composite response
20.8%
insulin
Source sentences
Summary
A total of 39.2 vs. 20.8% of patients reached the composite end point of A1C <7.0%, no weight gain, and no hypoglycemia (P < 0.001; post hoc analysis).
1 context sentence(design, population, supporting numbers)
Summary · context
In this open-label study, metformin-treated adults with type 2 diabetes were randomized to 26-week treatment with exenatide BID (4 weeks 5 μg, then 10 μg) or PIA.
Report a problemFND-2128538804

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 postedNCT00434954

Effect of Exenatide Plus Metformin vs. Insulin Aspart Plus Metformin on Glycemic Control and Hypoglycemia in Patients With Type 2 Diabetes

AstraZenecan = 494Feb 2007 to Jun 2009

Type 2 Diabetes Mellitus

Trial page ClinicalTrials.govUpdated 7 Apr 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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