Efficacy and safety of biphasic insulin aspart 70/30 versus exenatide in subjects with type 2 diabetes failing to achieve glycemic control with metformin and a sulfonylurea.

Bergenstal R, Lewin A, Bailey T, Chang D, Gylvin T, Roberts V

Current medical research and opinion1 Jan 2009Cited by 68 (Europe PMC)

PMID19210140DOI10.1185/03007990802597951PepBankPUB-19210140

Publisher page PubMedAsk about this study

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
In patients with type 2 diabetes, HbA1c was higher with exenatide than with twice-daily biphasic insulin aspart.
In plain wordsIn patients with diabetes, exenatide produced higher HbA1c than twice-daily biphasic insulin aspart.
Peptide
Exenatide (exendin-4)
Outcome
IncreaseHbA1c
Study
n: not reported in source
Comparator
BIAsp 30 BID
Outcome group
Glycemic control · Metabolic and weight
Studied dose
5 microg BID for 4 weeks and 10 microg BID thereafter · 24 weeksAs given in this study (human).
Measurements
HbA1c difference (BIAsp 30 BID minus exenatide)
−0.91%
BIAsp 30 BID versus exenatide
Source sentences
Summary
Glycemic control achieved with both BIAsp 30 BID and BIAsp 30 QD was superior to that with exenatide (BIAsp 30 BID-exenatide: HbA1c difference -0.91% [95% CI: -1.23 to -0.59%] and BIAsp 30 QD-exenatide: difference: -0.67% [95% CI: -0.99 to -0.34%]).
2 context sentences(design, population, supporting numbers)
Summary · context
To compare safety and efficacy of biphasic insulin aspart 70/30 (BIAsp 30) with exenatide in subjects with type 2 diabetes mellitus (T2DM) not achieving glycemic targets with metformin and sulfonylurea in a randomized, open-label, 24-week trial.
Summary · context
or exenatide (5 microg BID for 4 weeks and 10 microg BID thereafter).
Report a problemFND-1921014001
02HumanRandomized controlled trialEfficacy outcome
In patients with type 2 diabetes, HbA1c was higher with exenatide than with once-daily biphasic insulin aspart.
In plain wordsIn patients with diabetes, exenatide produced higher HbA1c than once-daily biphasic insulin aspart.
Peptide
Exenatide (exendin-4)
Outcome
IncreaseHbA1c
Study
n: not reported in source
Comparator
BIAsp 30 QD
Outcome group
Glycemic control · Metabolic and weight
Studied dose
5 microg BID for 4 weeks and 10 microg BID thereafter · 24 weeksAs given in this study (human).
Measurements
HbA1c difference (BIAsp 30 QD minus exenatide)
−0.67%
BIAsp 30 QD versus exenatide
Source sentences
Summary
Glycemic control achieved with both BIAsp 30 BID and BIAsp 30 QD was superior to that with exenatide (BIAsp 30 BID-exenatide: HbA1c difference -0.91% [95% CI: -1.23 to -0.59%] and BIAsp 30 QD-exenatide: difference: -0.67% [95% CI: -0.99 to -0.34%]).
2 context sentences(design, population, supporting numbers)
Summary · context
To compare safety and efficacy of biphasic insulin aspart 70/30 (BIAsp 30) with exenatide in subjects with type 2 diabetes mellitus (T2DM) not achieving glycemic targets with metformin and sulfonylurea in a randomized, open-label, 24-week trial.
Summary · context
or exenatide (5 microg BID for 4 weeks and 10 microg BID thereafter).
Report a problemFND-1921014002
03HumanRandomized controlled trialEfficacy outcome
In patients with type 2 diabetes, fewer exenatide recipients achieved HbA1c below 7% than twice-daily biphasic insulin aspart recipients.
In plain wordsIn patients with diabetes, fewer exenatide recipients reached HbA1c below 7% than twice-daily biphasic insulin aspart recipients.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseHbA1c below 7%
Study
n: not reported in source
Comparator
BIAsp 30 BID
Outcome group
Glycemic control · Metabolic and weight
Studied dose
5 microg BID for 4 weeks and 10 microg BID thereafter · 24 weeksAs given in this study (human).
Measurements
Responders HbA1c <7%
20%
exenatide
Responders HbA1c <7%
37%
BIAsp 30 BID
Source sentences
Summary
At the end of the study, more subjects achieved HbA1c < 7% and < or = 6.5% in the BIAsp 30 BID group than in the exenatide group (HbA1c < 7%: 37% vs. 20%, p = 0.0060; HbA1c < or = 6.5%: 25% vs. 8%, p = 0.0004, respectively).
2 context sentences(design, population, supporting numbers)
Summary · context
To compare safety and efficacy of biphasic insulin aspart 70/30 (BIAsp 30) with exenatide in subjects with type 2 diabetes mellitus (T2DM) not achieving glycemic targets with metformin and sulfonylurea in a randomized, open-label, 24-week trial.
Summary · context
or exenatide (5 microg BID for 4 weeks and 10 microg BID thereafter).
Report a problemFND-1921014003
04HumanRandomized controlled trialEfficacy outcome
In patients with type 2 diabetes, fewer exenatide recipients achieved HbA1c at most 6.5% than twice-daily biphasic insulin aspart recipients.
In plain wordsIn patients with diabetes, fewer exenatide recipients reached HbA1c at most 6.5% than twice-daily biphasic insulin aspart recipients.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseHbA1c at most 6.5%
Study
n: not reported in source
Comparator
BIAsp 30 BID
Outcome group
Glycemic control · Metabolic and weight
Studied dose
5 microg BID for 4 weeks and 10 microg BID thereafter · 24 weeksAs given in this study (human).
Measurements
Responders HbA1c <=6.5%
8%
exenatide
Responders HbA1c <=6.5%
25%
BIAsp 30 BID
Source sentences
Summary
At the end of the study, more subjects achieved HbA1c < 7% and < or = 6.5% in the BIAsp 30 BID group than in the exenatide group (HbA1c < 7%: 37% vs. 20%, p = 0.0060; HbA1c < or = 6.5%: 25% vs. 8%, p = 0.0004, respectively).
2 context sentences(design, population, supporting numbers)
Summary · context
To compare safety and efficacy of biphasic insulin aspart 70/30 (BIAsp 30) with exenatide in subjects with type 2 diabetes mellitus (T2DM) not achieving glycemic targets with metformin and sulfonylurea in a randomized, open-label, 24-week trial.
Summary · context
or exenatide (5 microg BID for 4 weeks and 10 microg BID thereafter).
Report a problemFND-1921014004
05HumanRandomized controlled trialSafety outcome
In patients with type 2 diabetes, combined hypoglycemic episodes were less frequent with exenatide than once-daily biphasic insulin aspart.
In plain wordsIn patients with diabetes, low blood sugar episodes were less frequent with exenatide than once-daily biphasic insulin aspart.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseCombined hypoglycemic episodes
Study
n: not reported in source
Comparator
BIAsp 30 QD
Outcome group
Adverse events · Metabolic and weight
Studied dose
5 microg BID for 4 weeks and 10 microg BID thereafter · 24 weeksAs given in this study (human).
Measurements
Patients with hypoglycemic episodes
29%
exenatide
Patients with hypoglycemic episodes
56%
BIAsp 30 QD
Source sentences
Summary
Combined hypoglycemic episodes (major, minor, symptoms only) were reported by 56%, 61%, and 29% of the subjects in the BIAsp 30 QD, BIAsp 30 BID, and exenatide groups, respectively.
2 context sentences(design, population, supporting numbers)
Summary · context
To compare safety and efficacy of biphasic insulin aspart 70/30 (BIAsp 30) with exenatide in subjects with type 2 diabetes mellitus (T2DM) not achieving glycemic targets with metformin and sulfonylurea in a randomized, open-label, 24-week trial.
Summary · context
or exenatide (5 microg BID for 4 weeks and 10 microg BID thereafter).
Report a problemFND-1921014005
06HumanRandomized controlled trialSafety outcome
In patients with type 2 diabetes, combined hypoglycemic episodes were less frequent with exenatide than twice-daily biphasic insulin aspart.
In plain wordsIn patients with diabetes, low blood sugar episodes were less frequent with exenatide than twice-daily biphasic insulin aspart.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseCombined hypoglycemic episodes
Study
n: not reported in source
Comparator
BIAsp 30 BID
Outcome group
Adverse events · Metabolic and weight
Studied dose
5 microg BID for 4 weeks and 10 microg BID thereafter · 24 weeksAs given in this study (human).
Measurements
Patients with hypoglycemic episodes
29%
exenatide
Patients with hypoglycemic episodes
61%
BIAsp 30 BID
Source sentences
Summary
Combined hypoglycemic episodes (major, minor, symptoms only) were reported by 56%, 61%, and 29% of the subjects in the BIAsp 30 QD, BIAsp 30 BID, and exenatide groups, respectively.
2 context sentences(design, population, supporting numbers)
Summary · context
To compare safety and efficacy of biphasic insulin aspart 70/30 (BIAsp 30) with exenatide in subjects with type 2 diabetes mellitus (T2DM) not achieving glycemic targets with metformin and sulfonylurea in a randomized, open-label, 24-week trial.
Summary · context
or exenatide (5 microg BID for 4 weeks and 10 microg BID thereafter).
Report a problemFND-1921014006
07HumanRandomized controlled trialEfficacy outcome
In patients with type 2 diabetes, exenatide reduced weight while once-daily biphasic insulin aspart increased weight.
In plain wordsIn patients with diabetes, exenatide reduced weight while once-daily biphasic insulin aspart increased weight.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseBody weight
Study
n: not reported in source
Comparator
BIAsp 30 QD
Outcome group
Body weight · Metabolic and weight
Studied dose
5 microg BID for 4 weeks and 10 microg BID thereafter · 24 weeksAs given in this study (human).
Measurements
Weight change
−1.96 kg
exenatide
Weight change
2.85 kg
BIAsp 30 QD
Source sentences
Summary
Weight gain was observed in the BIAsp 30 group (BIAsp 30 QD: 2.85 kg, BIAsp 30 BID: 4.08 kg) and weight loss was observed in the exenatide group (-1.96 kg).
2 context sentences(design, population, supporting numbers)
Summary · context
To compare safety and efficacy of biphasic insulin aspart 70/30 (BIAsp 30) with exenatide in subjects with type 2 diabetes mellitus (T2DM) not achieving glycemic targets with metformin and sulfonylurea in a randomized, open-label, 24-week trial.
Summary · context
or exenatide (5 microg BID for 4 weeks and 10 microg BID thereafter).
Report a problemFND-1921014007
08HumanRandomized controlled trialEfficacy outcome
In patients with type 2 diabetes, exenatide reduced weight while twice-daily biphasic insulin aspart increased weight.
In plain wordsIn patients with diabetes, exenatide reduced weight while twice-daily biphasic insulin aspart increased weight.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseBody weight
Study
n: not reported in source
Comparator
BIAsp 30 BID
Outcome group
Body weight · Metabolic and weight
Studied dose
5 microg BID for 4 weeks and 10 microg BID thereafter · 24 weeksAs given in this study (human).
Measurements
Weight change
−1.96 kg
exenatide
Weight change
4.08 kg
BIAsp 30 BID
Source sentences
Summary
Weight gain was observed in the BIAsp 30 group (BIAsp 30 QD: 2.85 kg, BIAsp 30 BID: 4.08 kg) and weight loss was observed in the exenatide group (-1.96 kg).
2 context sentences(design, population, supporting numbers)
Summary · context
To compare safety and efficacy of biphasic insulin aspart 70/30 (BIAsp 30) with exenatide in subjects with type 2 diabetes mellitus (T2DM) not achieving glycemic targets with metformin and sulfonylurea in a randomized, open-label, 24-week trial.
Summary · context
or exenatide (5 microg BID for 4 weeks and 10 microg BID thereafter).
Report a problemFND-1921014008
09HumanRandomized controlled trialSafety outcome
In patients with type 2 diabetes, nausea or vomiting caused more discontinuations with exenatide than twice-daily biphasic insulin aspart.
In plain wordsIn patients with diabetes, nausea or vomiting caused more discontinuations with exenatide than twice-daily biphasic insulin aspart.
Peptide
Exenatide (exendin-4)
Outcome
IncreaseDiscontinuation due to nausea or vomiting
Study
n: not reported in source
Comparator
BIAsp 30 BID
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
5 microg BID for 4 weeks and 10 microg BID thereafter · 24 weeksAs given in this study (human).
Measurements
Discontinuations
7 subjects
exenatide
Discontinuations
1 subjects
BIAsp 30 BID
Source sentences
Summary
Nausea or vomiting was responsible for discontinuation of seven subjects in the exenatide group and one subject in the BIAsp 30 BID group.
2 context sentences(design, population, supporting numbers)
Summary · context
To compare safety and efficacy of biphasic insulin aspart 70/30 (BIAsp 30) with exenatide in subjects with type 2 diabetes mellitus (T2DM) not achieving glycemic targets with metformin and sulfonylurea in a randomized, open-label, 24-week trial.
Summary · context
or exenatide (5 microg BID for 4 weeks and 10 microg BID thereafter).
Report a problemFND-1921014009

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 · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3NCT00313001

Effects of Biphasic Insulin Aspart 70/30 vs. Exenatide in Type 2 Diabetes Patients Not Reaching Blood Glucose Targets on Metformin and a Sulfonylurea.

Novo Nordisk A/Sn = 373Apr 2006 to Jul 2007

Diabetes · Diabetes Mellitus, Type 2

Trial page ClinicalTrials.govUpdated 6 Jan 2017

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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