A comparison of twice-daily exenatide and biphasic insulin aspart in patients with type 2 diabetes who were suboptimally controlled with sulfonylurea and metformin: a non-inferiority study.

Nauck MA, Duran S, Kim D, Johns D, Northrup J, Festa A, Brodows R, Trautmann M

Diabetologia8 Dec 2006Cited by 312 (Europe PMC)

PMID17160407DOI10.1007/s00125-006-0510-2PepBankPUB-17160407

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

8 results from studies that gave the peptide. 8 results from people.

01HumanRandomized controlled trialEfficacy outcome
In T2D patients receiving metformin and sulfonylurea, exenatide was non-inferior to biphasic insulin aspart for HbA1c reduction.
In plain wordsExenatide lowered HbA1c with non-inferior results to biphasic insulin aspart.
Peptide
Exenatide (exendin-4)
Outcome
No significant changeHbA1c change
Study
n = 501
Comparator
Biphasic insulin aspart
Outcome group
Glycemic control · Metabolic and weight
Studied dose
5 microg twice daily for 4 weeks, 10 microg thereafter · 52 weeksAs given in this study (human).
Measurements
HbA1c change
−1.04%
exenatide
HbA1c change
−0.89%
biphasic insulin aspart
Between-group difference
−0.15%
exenatide versus insulin
95% CI of between-group difference
−0.32 to 0.01%
exenatide versus insulin
Source sentences
Summary
Glycaemic control achieved with exenatide was non-inferior to that achieved with biphasic insulin aspart (mean+/-SEM, HbA(1c) change: exenatide -1.04 +/- 0.07%, biphasic insulin aspart -0.89 +/- 0.06%; difference -0.15 [95% CI -0.32 to 0.01]%).
2 context sentences(design, population, supporting numbers)
Summary · context
The aim of this 52-week, open-label, non-inferiority trial was to compare the safety and efficacy of exenatide (an incretin mimetic) with that of biphasic insulin aspart.
Summary · context
Patients on metformin and a sulfonylurea were randomised to exenatide (n = 253; 5 microg twice daily for 4 weeks, 10 microg thereafter) or biphasic insulin aspart (n = 248; twice-daily doses titrated for optimal glucose control), while continuing with metformin and sulfonylurea treatment.
Report a problemFND-1716040701
02HumanRandomized controlled trialEfficacy outcome
In T2D patients, exenatide reduced weight while biphasic insulin aspart increased it.
In plain wordsPatients lost weight with exenatide but gained weight with biphasic insulin aspart.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseBody weight
Study
n = 501
Comparator
Biphasic insulin aspart
Outcome group
Body weight · Metabolic and weight
Studied dose
5 microg twice daily for 4 weeks, 10 microg thereafter · 52 weeksAs given in this study (human).
Measurements
Between-group weight difference
−5.4 kg
exenatide versus insulin
95% CI of between-group weight difference
−5.9 to −5 kg
exenatide versus insulin
Source sentences
Summary
Exenatide-treated patients lost weight, while patients treated with biphasic insulin aspart gained weight [between-group difference -5.4 (95% CI -5.9 to -5.0) kg].
2 context sentences(design, population, supporting numbers)
Summary · context
The aim of this 52-week, open-label, non-inferiority trial was to compare the safety and efficacy of exenatide (an incretin mimetic) with that of biphasic insulin aspart.
Summary · context
Patients on metformin and a sulfonylurea were randomised to exenatide (n = 253; 5 microg twice daily for 4 weeks, 10 microg thereafter) or biphasic insulin aspart (n = 248; twice-daily doses titrated for optimal glucose control), while continuing with metformin and sulfonylurea treatment.
Report a problemFND-1716040702
03HumanRandomized controlled trialEfficacy outcome
In T2D patients, exenatide reduced morning postprandial glucose excursions more than biphasic insulin aspart.
In plain wordsExenatide reduced morning after-meal glucose rises more than biphasic insulin aspart.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseMorning postprandial glucose excursion
Study
n = 501
Comparator
Biphasic insulin aspart
Outcome group
Glycemic control · Metabolic and weight
Studied dose
5 microg twice daily for 4 weeks, 10 microg thereafter · 52 weeksAs given in this study (human).
Source sentences
Summary
Greater reductions in postprandial glucose excursions following morning (p < 0.001), midday (p = 0.002) and evening meals (p < 0.001) were observed with exenatide.
2 context sentences(design, population, supporting numbers)
Summary · context
The aim of this 52-week, open-label, non-inferiority trial was to compare the safety and efficacy of exenatide (an incretin mimetic) with that of biphasic insulin aspart.
Summary · context
Patients on metformin and a sulfonylurea were randomised to exenatide (n = 253; 5 microg twice daily for 4 weeks, 10 microg thereafter) or biphasic insulin aspart (n = 248; twice-daily doses titrated for optimal glucose control), while continuing with metformin and sulfonylurea treatment.
Report a problemFND-1716040704
04HumanRandomized controlled trialEfficacy outcome
In T2D patients, exenatide reduced midday postprandial glucose excursions more than biphasic insulin aspart.
In plain wordsExenatide reduced midday after-meal glucose rises more than biphasic insulin aspart.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseMidday postprandial glucose excursion
Study
n = 501
Comparator
Biphasic insulin aspart
Outcome group
Glycemic control · Metabolic and weight
Studied dose
5 microg twice daily for 4 weeks, 10 microg thereafter · 52 weeksAs given in this study (human).
Source sentences
Summary
Greater reductions in postprandial glucose excursions following morning (p < 0.001), midday (p = 0.002) and evening meals (p < 0.001) were observed with exenatide.
2 context sentences(design, population, supporting numbers)
Summary · context
The aim of this 52-week, open-label, non-inferiority trial was to compare the safety and efficacy of exenatide (an incretin mimetic) with that of biphasic insulin aspart.
Summary · context
Patients on metformin and a sulfonylurea were randomised to exenatide (n = 253; 5 microg twice daily for 4 weeks, 10 microg thereafter) or biphasic insulin aspart (n = 248; twice-daily doses titrated for optimal glucose control), while continuing with metformin and sulfonylurea treatment.
Report a problemFND-1716040705
05HumanRandomized controlled trialEfficacy outcome
In T2D patients, exenatide reduced evening postprandial glucose excursions more than biphasic insulin aspart.
In plain wordsExenatide reduced evening after-meal glucose rises more than biphasic insulin aspart.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseEvening postprandial glucose excursion
Study
n = 501
Comparator
Biphasic insulin aspart
Outcome group
Glycemic control · Metabolic and weight
Studied dose
5 microg twice daily for 4 weeks, 10 microg thereafter · 52 weeksAs given in this study (human).
Source sentences
Summary
Greater reductions in postprandial glucose excursions following morning (p < 0.001), midday (p = 0.002) and evening meals (p < 0.001) were observed with exenatide.
2 context sentences(design, population, supporting numbers)
Summary · context
The aim of this 52-week, open-label, non-inferiority trial was to compare the safety and efficacy of exenatide (an incretin mimetic) with that of biphasic insulin aspart.
Summary · context
Patients on metformin and a sulfonylurea were randomised to exenatide (n = 253; 5 microg twice daily for 4 weeks, 10 microg thereafter) or biphasic insulin aspart (n = 248; twice-daily doses titrated for optimal glucose control), while continuing with metformin and sulfonylurea treatment.
Report a problemFND-1716040706
06HumanRandomized controlled trialOther
In T2D patients, withdrawal was more frequent with exenatide than biphasic insulin aspart.
In plain wordsMore patients withdrew with exenatide than with biphasic insulin aspart.
Peptide
Exenatide (exendin-4)
Outcome
IncreaseWithdrawal rate
Study
n = 501
Comparator
Biphasic insulin aspart
Outcome group
Treatment adherence and retention · Whole body
Studied dose
5 microg twice daily for 4 weeks, 10 microg thereafter · 52 weeksAs given in this study (human).
Measurements
Withdrawal rate
21.3%
exenatide
Withdrawal rate
10.1%
biphasic insulin aspart
Source sentences
Summary
The withdrawal rate was 21.3% (54/253) for exenatide and 10.1% (25/248) for biphasic insulin aspart.
2 context sentences(design, population, supporting numbers)
Summary · context
The aim of this 52-week, open-label, non-inferiority trial was to compare the safety and efficacy of exenatide (an incretin mimetic) with that of biphasic insulin aspart.
Summary · context
Patients on metformin and a sulfonylurea were randomised to exenatide (n = 253; 5 microg twice daily for 4 weeks, 10 microg thereafter) or biphasic insulin aspart (n = 248; twice-daily doses titrated for optimal glucose control), while continuing with metformin and sulfonylurea treatment.
Report a problemFND-1716040707
07HumanRandomized controlled trialSafety outcome
In T2D patients, nausea was the most common adverse event with exenatide.
In plain wordsNausea was the most common exenatide side effect in patients with T2D.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableNausea incidence
Study
n = 253
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
5 microg twice daily for 4 weeks, 10 microg thereafter · 52 weeksAs given in this study (human).
Measurements
Nausea incidence
33%
exenatide
Source sentences
Summary
Nausea (33% incidence, 3.5% discontinuation) was the most common adverse event observed with exenatide.
2 context sentences(design, population, supporting numbers)
Summary · context
The aim of this 52-week, open-label, non-inferiority trial was to compare the safety and efficacy of exenatide (an incretin mimetic) with that of biphasic insulin aspart.
Summary · context
Patients on metformin and a sulfonylurea were randomised to exenatide (n = 253; 5 microg twice daily for 4 weeks, 10 microg thereafter) or biphasic insulin aspart (n = 248; twice-daily doses titrated for optimal glucose control), while continuing with metformin and sulfonylurea treatment.
Report a problemFND-1716040708
08HumanRandomized controlled trialSafety outcome
In T2D patients, nausea caused some exenatide discontinuations.
In plain wordsSome patients stopped exenatide because of nausea.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableNausea discontinuation
Study
n = 253
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
5 microg twice daily for 4 weeks, 10 microg thereafter · 52 weeksAs given in this study (human).
Measurements
Nausea discontinuation
3.5%
exenatide
Source sentences
Summary
Nausea (33% incidence, 3.5% discontinuation) was the most common adverse event observed with exenatide.
2 context sentences(design, population, supporting numbers)
Summary · context
The aim of this 52-week, open-label, non-inferiority trial was to compare the safety and efficacy of exenatide (an incretin mimetic) with that of biphasic insulin aspart.
Summary · context
Patients on metformin and a sulfonylurea were randomised to exenatide (n = 253; 5 microg twice daily for 4 weeks, 10 microg thereafter) or biphasic insulin aspart (n = 248; twice-daily doses titrated for optimal glucose control), while continuing with metformin and sulfonylurea treatment.
Report a problemFND-1716040709

Studies that did not test the peptide alone1

In this study, Exenatide (exendin-4) 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 Exenatide (exendin-4).

09HumanNot a test of Exenatide (exendin-4) aloneRandomized controlled trialEfficacy outcome
In T2D patients, exenatide reduced fasting serum glucose from baseline, as did biphasic insulin aspart.
In plain wordsFasting glucose fell from baseline with both exenatide and biphasic insulin aspart.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseFasting serum glucose
Study
n = 253
Comparator
Baseline
Outcome group
Glycemic control · Metabolic and weight
Measurements
Fasting serum glucose change
−1.8 mmol/l
exenatide
Fasting serum glucose change
−1.7 mmol/l
biphasic insulin aspart
Source sentences
Summary
Both treatments reduced fasting serum glucose (exenatide -1.8 +/- 0.2 mmol/l, p < 0.001; biphasic insulin aspart -1.7 +/- 0.2 mmol/l, p < 0.001).
2 context sentences(design, population, supporting numbers)
Summary · context
The aim of this 52-week, open-label, non-inferiority trial was to compare the safety and efficacy of exenatide (an incretin mimetic) with that of biphasic insulin aspart.
Summary · context
Patients on metformin and a sulfonylurea were randomised to exenatide (n = 253; 5 microg twice daily for 4 weeks, 10 microg thereafter) or biphasic insulin aspart (n = 248; twice-daily doses titrated for optimal glucose control), while continuing with metformin and sulfonylurea treatment.
In this study, Exenatide (exendin-4) 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 Exenatide (exendin-4).
Report a problemFND-1716040703

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 postedNCT00082407

Exenatide Compared With Twice-Daily Biphasic Insulin Aspart in Patients With Type 2 Diabetes Using Sulfonylurea and Metformin

AstraZenecan = 505Nov 2003 to Jul 2008

Diabetes Mellitus, Type 2

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

Subjects

Terms as the source lists them.

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