Tolerability and efficacy of exenatide and titrated insulin glargine in adult patients with type 2 diabetes previously uncontrolled with metformin or a sulfonylurea: a multinational, randomized, open-label, two-period, crossover noninferiority trial.

Barnett AH, Burger J, Johns D, Brodows R, Kendall DM, Roberts A, Trautmann ME

Clinical therapeutics1 Nov 2007Cited by 188 (Europe PMC)

PMID18158075DOI10.1016/j.clinthera.2007.11.006PepBankPUB-18158075

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 study11

11 results from studies that gave the peptide. 11 results from people.

01HumanRandomized controlled trialEfficacy outcome
In adults with diabetes, HbA1c reductions did not differ significantly between exenatide and insulin glargine.
In plain wordsExenatide and insulin glargine reduced blood sugar similarly in adults with diabetes.
Peptide
Exenatide (exendin-4)
Outcome
No significant changeHbA1c change
Study
n = 138
Comparator
Insulin glargine
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
10 pg BID · 16 weeksAs given in this study (human).
Measurements
HbA1c change
−1.36%
both treatments
Source sentences
Summary
Both exenatide and titrated insulin glargine therapy were associated with similar significant changes from baseline in HbA(1c) (both, -1.36% [0.09%]; P < 0.001); the difference between groups was not statistically significant.
2 context sentences(design, population, supporting numbers)
Summary · context
This multinational, randomized, open-label, crossover noninferiority study compared the efficacy of exenatide 10 pg BID and insulin glargine QD (titrated targeting a fasting serum glucose (FSG) level < or =5.6 mmol/L) in patients with type 2 diabetes treated with a single oral antidiabetic agent.
Summary · context
The study included two 16-week treatment periods.
Report a problemFND-1815807501
02HumanRandomized controlled trialEfficacy outcome
In adults with diabetes, similar proportions reached the ADA HbA1c target with exenatide and insulin glargine.
In plain wordsSimilar proportions reached the blood sugar target with exenatide and insulin glargine.
Peptide
Exenatide (exendin-4)
Outcome
No significant changeHbA1c target <=7%
Study
n = 138
Comparator
Insulin glargine
Analysis
Secondary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
10 pg BID · 16 weeksAs given in this study (human).
Measurements
Target attainment
37.5%
exenatide
Target attainment
39.8%
insulin glargine
Source sentences
Summary
Similar proportions of patients achieved an HbA(1c) < or =7% (37.5% and 39.8%, respectively; P = NS) or < or =6.5% (21.5% and 13.6%).
2 context sentences(design, population, supporting numbers)
Summary · context
This multinational, randomized, open-label, crossover noninferiority study compared the efficacy of exenatide 10 pg BID and insulin glargine QD (titrated targeting a fasting serum glucose (FSG) level < or =5.6 mmol/L) in patients with type 2 diabetes treated with a single oral antidiabetic agent.
Summary · context
The study included two 16-week treatment periods.
Report a problemFND-1815807503
03HumanRandomized controlled trialEfficacy outcome
In adults with diabetes, similar proportions reached the stricter HbA1c target with exenatide and insulin glargine.
In plain wordsSimilar proportions reached the stricter blood sugar target with exenatide and insulin glargine.
Peptide
Exenatide (exendin-4)
Outcome
No significant changeHbA1c target <=6.5%
Study
n = 138
Comparator
Insulin glargine
Analysis
Secondary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
10 pg BID · 16 weeksAs given in this study (human).
Measurements
Target attainment
21.5%
exenatide
Target attainment
13.6%
insulin glargine
Source sentences
Summary
Similar proportions of patients achieved an HbA(1c) < or =7% (37.5% and 39.8%, respectively; P = NS) or < or =6.5% (21.5% and 13.6%).
2 context sentences(design, population, supporting numbers)
Summary · context
This multinational, randomized, open-label, crossover noninferiority study compared the efficacy of exenatide 10 pg BID and insulin glargine QD (titrated targeting a fasting serum glucose (FSG) level < or =5.6 mmol/L) in patients with type 2 diabetes treated with a single oral antidiabetic agent.
Summary · context
The study included two 16-week treatment periods.
Report a problemFND-1815807504
04HumanRandomized controlled trialEfficacy outcome
In adults with diabetes, exenatide reduced weight whereas insulin glargine increased weight.
In plain wordsAdults lost weight with exenatide but gained weight with insulin glargine.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseBody weight change
Study
n = 138
Comparator
Insulin glargine
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Studied dose
10 pg BID · 16 weeksAs given in this study (human).
Measurements
Between-group weight difference
−2.2 kg
exenatide versus insulin glargine
Source sentences
Summary
Patients lost weight during exenatide treatment, whereas they gained weight during insulin glargine treatment; the between-group difference in weight change was statistically significant (LS mean difference, -2.2 [0.3] kg; 95% CI, -2.8 to-1.7; P < 0.001).
2 context sentences(design, population, supporting numbers)
Summary · context
This multinational, randomized, open-label, crossover noninferiority study compared the efficacy of exenatide 10 pg BID and insulin glargine QD (titrated targeting a fasting serum glucose (FSG) level < or =5.6 mmol/L) in patients with type 2 diabetes treated with a single oral antidiabetic agent.
Summary · context
The study included two 16-week treatment periods.
Report a problemFND-1815807505
05HumanRandomized controlled trialEfficacy outcome
In adults with diabetes, fasting glucose decreased less with exenatide than insulin glargine.
In plain wordsExenatide reduced fasting blood sugar less than insulin glargine.
Peptide
Exenatide (exendin-4)
Outcome
IncreaseFasting serum glucose
Study
n = 138
Comparator
Insulin glargine
Analysis
Secondary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
10 pg BID · 16 weeksAs given in this study (human).
Measurements
FSG change
−2.9 mmol/L
exenatide
FSG change
−4.1 mmol/L
insulin glargine
Between-group difference in FSG reduction
1.2 mmol/L
insulin glargine versus exenatide
Source sentences
Summary
Both exenatide and insulin glargine were associated with significant reductions from baseline in FSG (-2.9 [0.2] and -4.1 [0.2] mmol/L, respectively; both, P < 0.001), although the reduction was significantly greater with insulin glargine compared with exenatide (LS mean difference, 1.2 [0.3] mmol/L…
1 context sentence(design, population, supporting numbers)
Summary · context
This multinational, randomized, open-label, crossover noninferiority study compared the efficacy of exenatide 10 pg BID and insulin glargine QD (titrated targeting a fasting serum glucose (FSG) level < or =5.6 mmol/L) in patients with type 2 diabetes treated with a single oral antidiabetic agent.
Report a problemFND-1815807506
06HumanRandomized controlled trialEfficacy outcome
In adults with diabetes, exenatide lowered postprandial glucose excursions more than insulin glargine.
In plain wordsExenatide reduced after-meal blood sugar excursions more than insulin glargine.
Peptide
Exenatide (exendin-4)
Outcome
DecreasePostprandial glucose excursions
Study
n = 138
Comparator
Insulin glargine
Analysis
Secondary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
10 pg BID · 16 weeksAs given in this study (human).
Source sentences
Summary
Compared with insulin glargine, exenatide was associated with significantly lower 2-hour postprandial glucose (PPG) excursions (P < 0.016) and total daily mean glucose excursion (P < 0.001).
2 context sentences(design, population, supporting numbers)
Summary · context
This multinational, randomized, open-label, crossover noninferiority study compared the efficacy of exenatide 10 pg BID and insulin glargine QD (titrated targeting a fasting serum glucose (FSG) level < or =5.6 mmol/L) in patients with type 2 diabetes treated with a single oral antidiabetic agent.
Summary · context
The study included two 16-week treatment periods.
Report a problemFND-1815807507
07HumanRandomized controlled trialEfficacy outcome
In adults with diabetes, exenatide lowered total daily mean glucose excursion more than insulin glargine.
In plain wordsExenatide reduced average daily blood sugar excursions more than insulin glargine.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseDaily mean glucose excursion
Study
n = 138
Comparator
Insulin glargine
Analysis
Secondary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
10 pg BID · 16 weeksAs given in this study (human).
Source sentences
Summary
Compared with insulin glargine, exenatide was associated with significantly lower 2-hour postprandial glucose (PPG) excursions (P < 0.016) and total daily mean glucose excursion (P < 0.001).
2 context sentences(design, population, supporting numbers)
Summary · context
This multinational, randomized, open-label, crossover noninferiority study compared the efficacy of exenatide 10 pg BID and insulin glargine QD (titrated targeting a fasting serum glucose (FSG) level < or =5.6 mmol/L) in patients with type 2 diabetes treated with a single oral antidiabetic agent.
Summary · context
The study included two 16-week treatment periods.
Report a problemFND-1815807508
08HumanRandomized controlled trialEfficacy outcome
In adults with diabetes, end-point HbA1c remained above the ADA target with exenatide and insulin glargine.
In plain wordsAverage final blood sugar remained above the target with both exenatide and insulin glargine.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableEnd-point HbA1c
Study
n = 138
Comparator
Insulin glargine
Outcome group
Glycemic control · Metabolic and weight
Studied dose
10 pg BID · 16 weeksAs given in this study (human).
Measurements
HbA1c
7.57%
exenatide
HbA1c
7.58%
insulin glargine
Source sentences
Summary
The LS mean HbA(1c) at end point was above the ADA target with both treatments (exenatide, 7.57% [0.09%]; insulin glargine, 7.58% [0.09%]).
2 context sentences(design, population, supporting numbers)
Summary · context
This multinational, randomized, open-label, crossover noninferiority study compared the efficacy of exenatide 10 pg BID and insulin glargine QD (titrated targeting a fasting serum glucose (FSG) level < or =5.6 mmol/L) in patients with type 2 diabetes treated with a single oral antidiabetic agent.
Summary · context
The study included two 16-week treatment periods.
Report a problemFND-1815807502
09HumanRandomized controlled trialSafety outcome
In adults with diabetes, nausea was reported more often with exenatide than insulin glargine.
In plain wordsNausea was more frequent with exenatide than insulin glargine.
Peptide
Exenatide (exendin-4)
Outcome
IncreaseNausea
Study
n = 138
Comparator
Insulin glargine
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
10 pg BID · 16 weeksAs given in this study (human).
Measurements
Nausea
42.6%
exenatide
Nausea
3.1%
insulin glargine
Source sentences
Summary
The proportions of patients reporting nausea during exenatide and insulin glargine treatment were 42.6% and 3.1%, respectively; the proportions reporting vomiting were 9.6% and 3.1%.
2 context sentences(design, population, supporting numbers)
Summary · context
This multinational, randomized, open-label, crossover noninferiority study compared the efficacy of exenatide 10 pg BID and insulin glargine QD (titrated targeting a fasting serum glucose (FSG) level < or =5.6 mmol/L) in patients with type 2 diabetes treated with a single oral antidiabetic agent.
Summary · context
The study included two 16-week treatment periods.
Report a problemFND-1815807509
10HumanRandomized controlled trialSafety outcome
In adults with diabetes, vomiting was reported more often with exenatide than insulin glargine.
In plain wordsVomiting was more frequent with exenatide than insulin glargine.
Peptide
Exenatide (exendin-4)
Outcome
IncreaseVomiting
Study
n = 138
Comparator
Insulin glargine
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
10 pg BID · 16 weeksAs given in this study (human).
Measurements
Vomiting
9.6%
exenatide
Vomiting
3.1%
insulin glargine
Source sentences
Summary
The proportions of patients reporting nausea during exenatide and insulin glargine treatment were 42.6% and 3.1%, respectively; the proportions reporting vomiting were 9.6% and 3.1%.
2 context sentences(design, population, supporting numbers)
Summary · context
This multinational, randomized, open-label, crossover noninferiority study compared the efficacy of exenatide 10 pg BID and insulin glargine QD (titrated targeting a fasting serum glucose (FSG) level < or =5.6 mmol/L) in patients with type 2 diabetes treated with a single oral antidiabetic agent.
Summary · context
The study included two 16-week treatment periods.
Report a problemFND-1815807510
11HumanRandomized controlled trialSafety outcome
In adults with diabetes, hypoglycemia incidence did not differ significantly between exenatide and insulin glargine.
In plain wordsLow blood sugar rates did not differ significantly between exenatide and insulin glargine.
Peptide
Exenatide (exendin-4)
Outcome
No significant changeHypoglycemia
Study
n = 138
Comparator
Insulin glargine
Outcome group
Adverse events · Metabolic and weight
Studied dose
10 pg BID · 16 weeksAs given in this study (human).
Measurements
Hypoglycemia
14.7%
exenatide
Hypoglycemia
25.2%
insulin glargine
Source sentences
Summary
The incidence of hypoglycemia in the 2 groups was 14.7% and 25.2% (P = NS).
2 context sentences(design, population, supporting numbers)
Summary · context
This multinational, randomized, open-label, crossover noninferiority study compared the efficacy of exenatide 10 pg BID and insulin glargine QD (titrated targeting a fasting serum glucose (FSG) level < or =5.6 mmol/L) in patients with type 2 diabetes treated with a single oral antidiabetic agent.
Summary · context
The study included two 16-week treatment periods.
Report a problemFND-1815807511

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

Subjects

Terms as the source lists them.

PepBank is a research reference. Talk to a doctor before you use any peptide.