Exenatide improves glycemic control and reduces body weight in subjects with type 2 diabetes: a dose-ranging study.

Poon T, Nelson P, Shen L, Mihm M, Taylor K, Fineman M, Kim D

Diabetes technology & therapeutics1 Jun 2005Cited by 71 (Europe PMC)

PMID15929678DOI10.1089/dia.2005.7.467PepBankPUB-15929678

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 study15

15 results from studies that gave the peptide. 15 results from people.

01HumanRandomized controlled trialSafety outcome
In type 2 diabetes, seven of 123 patients randomized to exenatide withdrew because of gastrointestinal effects.
In plain wordsSeven of 123 patients assigned exenatide stopped treatment because of digestive effects.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableWithdrawal due to gastrointestinal effects
Study
n = 123
Outcome group
Adverse events · Gastrointestinal
Studied dose
Dose not stated · 28 daysAs given in this study (human).
Measurements
Withdrawals due to gastrointestinal effects
7 patients
of 123 patients randomized to exenatide
Source sentences
Summary
The most common adverse event was mild-to-moderate nausea that was dose-dependent (seven of 123 patients randomized to exenatide withdrew from the study because of gastrointestinal effects).
1 context sentence(design, population, supporting numbers)
Summary · context
In this randomized, triple-blinded, placebo-controlled Phase 2 clinical trial, 156 patients were randomized to placebo or exenatide at 2.5, 5.0, 7.5, or 10.0 microg administered b.i.d. for 28 days.
Report a problemFND-1592967816
02HumanRandomized controlled trialEfficacy outcome
In type 2 diabetes, exenatide reduced HbA1c by 0.3% from baseline within a significant dose-response trend versus placebo.
In plain wordsExenatide reduced HbA1c in patients with type 2 diabetes within a dose-response trend compared with placebo.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseHbA1c change
Study
n: not reported in source
Comparator
Placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
2.5 microg twice daily · 28 daysAs given in this study (human).
Measurements
HbA1c change from baseline
−0.3%
exenatide 2.5 microg b.i.d., day 28 (SE 0.1)
HbA1c change from baseline
0.1%
placebo, day 28 (SE 0.1); sign not shown in abstract
Source sentences
Summary
After 28 days of therapy, exenatide was associated with significant (P < 0.0001, linear contrast testing), dose-dependent reductions in HbA 1c (0.1 +/- 0.1%, -0.3 +/- 0.1%, -0.4 +/- 0.1%, +/-0.5 +/- 0.0%, and -0.5 +/- 0.1% for placebo and 2.5, 5.0, 7.5, and 10.0 microg b.i.d. exenatide, respectively)
1 context sentence(design, population, supporting numbers)
Summary · context
In this randomized, triple-blinded, placebo-controlled Phase 2 clinical trial, 156 patients were randomized to placebo or exenatide at 2.5, 5.0, 7.5, or 10.0 microg administered b.i.d. for 28 days.
Report a problemFND-1592967801
03HumanRandomized controlled trialEfficacy outcome
In type 2 diabetes, exenatide reduced HbA1c by 0.4% from baseline within a significant dose-response trend versus placebo.
In plain wordsExenatide reduced HbA1c in patients with type 2 diabetes within a dose-response trend compared with placebo.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseHbA1c change
Study
n: not reported in source
Comparator
Placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
5.0 microg twice daily · 28 daysAs given in this study (human).
Measurements
HbA1c change from baseline
−0.4%
exenatide 5.0 microg b.i.d., day 28 (SE 0.1)
HbA1c change from baseline
0.1%
placebo, day 28 (SE 0.1); sign not shown in abstract
Source sentences
Summary
After 28 days of therapy, exenatide was associated with significant (P < 0.0001, linear contrast testing), dose-dependent reductions in HbA 1c (0.1 +/- 0.1%, -0.3 +/- 0.1%, -0.4 +/- 0.1%, +/-0.5 +/- 0.0%, and -0.5 +/- 0.1% for placebo and 2.5, 5.0, 7.5, and 10.0 microg b.i.d. exenatide, respectively)
1 context sentence(design, population, supporting numbers)
Summary · context
In this randomized, triple-blinded, placebo-controlled Phase 2 clinical trial, 156 patients were randomized to placebo or exenatide at 2.5, 5.0, 7.5, or 10.0 microg administered b.i.d. for 28 days.
Report a problemFND-1592967802
04HumanRandomized controlled trialEfficacy outcome
In type 2 diabetes, HbA1c at day 28 with exenatide 7.5 microg b.i.d. is printed as +/-0.5 +/- 0.0%, so the sign is unclear, within a significant dose-dependent reduction trend versus placebo.
In plain wordsThe abstract prints the HbA1c change for the 7.5 microg dose with an unclear sign, within an overall dose-dependent reduction trend versus placebo.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseHbA1c change
Study
n: not reported in source
Comparator
Placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
7.5 microg twice daily · 28 daysAs given in this study (human).
Measurements
HbA1c change from baseline
0.5%
exenatide 7.5 microg b.i.d., day 28 (SE 0.0); abstract prints '+/-0.5', sign unclear
HbA1c change from baseline
0.1%
placebo, day 28 (SE 0.1); sign not shown in abstract
Source sentences
Summary
After 28 days of therapy, exenatide was associated with significant (P < 0.0001, linear contrast testing), dose-dependent reductions in HbA 1c (0.1 +/- 0.1%, -0.3 +/- 0.1%, -0.4 +/- 0.1%, +/-0.5 +/- 0.0%, and -0.5 +/- 0.1% for placebo and 2.5, 5.0, 7.5, and 10.0 microg b.i.d. exenatide, respectively)
1 context sentence(design, population, supporting numbers)
Summary · context
In this randomized, triple-blinded, placebo-controlled Phase 2 clinical trial, 156 patients were randomized to placebo or exenatide at 2.5, 5.0, 7.5, or 10.0 microg administered b.i.d. for 28 days.
Report a problemFND-1592967803
05HumanRandomized controlled trialEfficacy outcome
In type 2 diabetes, exenatide reduced HbA1c by 0.5% from baseline within a significant dose-response trend versus placebo.
In plain wordsExenatide reduced HbA1c in patients with type 2 diabetes within a dose-response trend compared with placebo.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseHbA1c change
Study
n: not reported in source
Comparator
Placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
10.0 microg twice daily · 28 daysAs given in this study (human).
Measurements
HbA1c change from baseline
−0.5%
exenatide 10.0 microg b.i.d., day 28 (SE 0.1)
HbA1c change from baseline
0.1%
placebo, day 28 (SE 0.1); sign not shown in abstract
Source sentences
Summary
After 28 days of therapy, exenatide was associated with significant (P < 0.0001, linear contrast testing), dose-dependent reductions in HbA 1c (0.1 +/- 0.1%, -0.3 +/- 0.1%, -0.4 +/- 0.1%, +/-0.5 +/- 0.0%, and -0.5 +/- 0.1% for placebo and 2.5, 5.0, 7.5, and 10.0 microg b.i.d. exenatide, respectively)
1 context sentence(design, population, supporting numbers)
Summary · context
In this randomized, triple-blinded, placebo-controlled Phase 2 clinical trial, 156 patients were randomized to placebo or exenatide at 2.5, 5.0, 7.5, or 10.0 microg administered b.i.d. for 28 days.
Report a problemFND-1592967804
06HumanRandomized controlled trialEfficacy outcome
In type 2 diabetes, fasting plasma glucose changed by -20.1 mg/dL with exenatide 2.5 microg b.i.d. versus +6.8 mg/dL with placebo at day 28; the dose trend was significant (P = 0.0006).
In plain wordsFasting blood sugar fell 20.1 mg/dL with exenatide 2.5 microg twice daily and rose 6.8 mg/dL with placebo in type 2 diabetes.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseFasting plasma glucose change
Study
n: not reported in source
Comparator
Placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
2.5 microg twice daily · 28 daysAs given in this study (human).
Measurements
Change in fasting plasma glucose
−20.1 mg/dL
exenatide 2.5 microg b.i.d., day 28
Change in fasting plasma glucose
6.8 mg/dL
placebo, day 28
Source sentences
Summary
and significant (P = 0.0006, linear contrast testing) reductions in fasting plasma glucose (+6.8 +/- 4.1, -20.1 +/- 5.2, -21.2 +/- 3.9, -17.7 +/- 4.8, and -17.3 +/- 4.4 mg/dL for placebo and 2.5, 5.0, 7.5, and 10.0 microg b.i.d. exenatide, respectively) by Day 28.
1 context sentence(design, population, supporting numbers)
Summary · context
In this randomized, triple-blinded, placebo-controlled Phase 2 clinical trial, 156 patients were randomized to placebo or exenatide at 2.5, 5.0, 7.5, or 10.0 microg administered b.i.d. for 28 days.
Report a problemFND-1592967805
07HumanRandomized controlled trialEfficacy outcome
In type 2 diabetes, fasting plasma glucose changed by -21.2 mg/dL with exenatide 5.0 microg b.i.d. versus +6.8 mg/dL with placebo at day 28; the dose trend was significant (P = 0.0006).
In plain wordsFasting blood sugar fell 21.2 mg/dL with exenatide 5.0 microg twice daily and rose 6.8 mg/dL with placebo in type 2 diabetes.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseFasting plasma glucose change
Study
n: not reported in source
Comparator
Placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
5.0 microg twice daily · 28 daysAs given in this study (human).
Measurements
Change in fasting plasma glucose
−21.2 mg/dL
exenatide 5.0 microg b.i.d., day 28
Change in fasting plasma glucose
6.8 mg/dL
placebo, day 28
Source sentences
Summary
and significant (P = 0.0006, linear contrast testing) reductions in fasting plasma glucose (+6.8 +/- 4.1, -20.1 +/- 5.2, -21.2 +/- 3.9, -17.7 +/- 4.8, and -17.3 +/- 4.4 mg/dL for placebo and 2.5, 5.0, 7.5, and 10.0 microg b.i.d. exenatide, respectively) by Day 28.
1 context sentence(design, population, supporting numbers)
Summary · context
In this randomized, triple-blinded, placebo-controlled Phase 2 clinical trial, 156 patients were randomized to placebo or exenatide at 2.5, 5.0, 7.5, or 10.0 microg administered b.i.d. for 28 days.
Report a problemFND-1592967806
08HumanRandomized controlled trialEfficacy outcome
In type 2 diabetes, fasting plasma glucose changed by -17.7 mg/dL with exenatide 7.5 microg b.i.d. versus +6.8 mg/dL with placebo at day 28; the dose trend was significant (P = 0.0006).
In plain wordsFasting blood sugar fell 17.7 mg/dL with exenatide 7.5 microg twice daily and rose 6.8 mg/dL with placebo in type 2 diabetes.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseFasting plasma glucose change
Study
n: not reported in source
Comparator
Placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
7.5 microg twice daily · 28 daysAs given in this study (human).
Measurements
Change in fasting plasma glucose
−17.7 mg/dL
exenatide 7.5 microg b.i.d., day 28
Change in fasting plasma glucose
6.8 mg/dL
placebo, day 28
Source sentences
Summary
and significant (P = 0.0006, linear contrast testing) reductions in fasting plasma glucose (+6.8 +/- 4.1, -20.1 +/- 5.2, -21.2 +/- 3.9, -17.7 +/- 4.8, and -17.3 +/- 4.4 mg/dL for placebo and 2.5, 5.0, 7.5, and 10.0 microg b.i.d. exenatide, respectively) by Day 28.
1 context sentence(design, population, supporting numbers)
Summary · context
In this randomized, triple-blinded, placebo-controlled Phase 2 clinical trial, 156 patients were randomized to placebo or exenatide at 2.5, 5.0, 7.5, or 10.0 microg administered b.i.d. for 28 days.
Report a problemFND-1592967807
09HumanRandomized controlled trialEfficacy outcome
In type 2 diabetes, fasting plasma glucose changed by -17.3 mg/dL with exenatide 10.0 microg b.i.d. versus +6.8 mg/dL with placebo at day 28; the dose trend was significant (P = 0.0006).
In plain wordsFasting blood sugar fell 17.3 mg/dL with exenatide 10.0 microg twice daily and rose 6.8 mg/dL with placebo in type 2 diabetes.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseFasting plasma glucose change
Study
n: not reported in source
Comparator
Placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
10.0 microg twice daily · 28 daysAs given in this study (human).
Measurements
Change in fasting plasma glucose
−17.3 mg/dL
exenatide 10.0 microg b.i.d., day 28
Change in fasting plasma glucose
6.8 mg/dL
placebo, day 28
Source sentences
Summary
and significant (P = 0.0006, linear contrast testing) reductions in fasting plasma glucose (+6.8 +/- 4.1, -20.1 +/- 5.2, -21.2 +/- 3.9, -17.7 +/- 4.8, and -17.3 +/- 4.4 mg/dL for placebo and 2.5, 5.0, 7.5, and 10.0 microg b.i.d. exenatide, respectively) by Day 28.
1 context sentence(design, population, supporting numbers)
Summary · context
In this randomized, triple-blinded, placebo-controlled Phase 2 clinical trial, 156 patients were randomized to placebo or exenatide at 2.5, 5.0, 7.5, or 10.0 microg administered b.i.d. for 28 days.
Report a problemFND-1592967808
10HumanRandomized controlled trialEfficacy outcome
In type 2 diabetes, exenatide-associated reductions in HbA1c and fasting plasma glucose were similar with diet/exercise and with metformin background treatment.
In plain wordsExenatide's HbA1c and fasting blood sugar reductions were similar with diet/exercise and with metformin background treatment.
Peptide
Exenatide (exendin-4)
Outcome
No significant changeHbA1c and fasting plasma glucose reductions by background therapy
Study
n: not reported in source
Comparator
Diet/exercise versus metformin background
Outcome group
Glycemic control · Metabolic and weight
Studied dose
Dose not stated · 28 daysAs given in this study (human).
Source sentences
Summary
These reductions were similar for patients treated with diet/exercise and those treated with metformin.
3 context sentences(design, population, supporting numbers)
Summary · context
After 28 days of therapy, exenatide was associated with significant (P < 0.0001, linear contrast testing), dose-dependent reductions in HbA 1c (0.1 +/- 0.1%, -0.3 +/- 0.1%, -0.4 +/- 0.1%, +/-0.5 +/- 0.0%, and -0.5 +/- 0.1% for placebo and 2.5, 5.0, 7.5, and 10.0 microg b.i.d. exenatide, respectively)
Summary · context
and significant (P = 0.0006, linear contrast testing) reductions in fasting plasma glucose (+6.8 +/- 4.1, -20.1 +/- 5.2, -21.2 +/- 3.9, -17.7 +/- 4.8, and -17.3 +/- 4.4 mg/dL for placebo and 2.5, 5.0, 7.5, and 10.0 microg b.i.d. exenatide, respectively) by Day 28.
Summary · context
In this randomized, triple-blinded, placebo-controlled Phase 2 clinical trial, 156 patients were randomized to placebo or exenatide at 2.5, 5.0, 7.5, or 10.0 microg administered b.i.d. for 28 days.
Report a problemFND-1592967809
11HumanRandomized controlled trialEfficacy outcome
In type 2 diabetes, body weight changed by -0.7 kg with exenatide 2.5 microg b.i.d. versus 0.0 kg with placebo at day 28; significance versus placebo was reported only for the 7.5 and 10.0 microg doses.
In plain wordsWeight fell 0.7 kg on exenatide 2.5 microg twice daily versus no change on placebo; only higher doses were reported as significant.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseWeight change
Study
n: not reported in source
Comparator
Placebo
Outcome group
Body weight · Metabolic and weight
Studied dose
2.5 microg twice daily · 28 daysAs given in this study (human).
Measurements
Change in body weight
−0.7 kg
exenatide 2.5 microg b.i.d., day 28
Change in body weight
0 kg
placebo, day 28
Source sentences
Summary
In addition, patients receiving exenatide exhibited dose-dependent reductions in body weight (0.0 +/- 0.3, -0.7 +/- 0.3, -0.7 +/- 0.2, -1.4 +/- 0.3, and -1.8 +/- 0.3 kg for placebo and 2.5, 5.0, 7.5, and 10.0 microg b.i.d. exenatide, respectively; P < 0.01 for 7.5 and 10.0 microg b.i.d. exenatide do…
1 context sentence(design, population, supporting numbers)
Summary · context
In this randomized, triple-blinded, placebo-controlled Phase 2 clinical trial, 156 patients were randomized to placebo or exenatide at 2.5, 5.0, 7.5, or 10.0 microg administered b.i.d. for 28 days.
Report a problemFND-1592967811
12HumanRandomized controlled trialEfficacy outcome
In type 2 diabetes, body weight changed by -0.7 kg with exenatide 5.0 microg b.i.d. versus 0.0 kg with placebo at day 28; significance versus placebo was reported only for the 7.5 and 10.0 microg doses.
In plain wordsWeight fell 0.7 kg on exenatide 5.0 microg twice daily versus no change on placebo; only higher doses were reported as significant.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseWeight change
Study
n: not reported in source
Comparator
Placebo
Outcome group
Body weight · Metabolic and weight
Studied dose
5.0 microg twice daily · 28 daysAs given in this study (human).
Measurements
Change in body weight
−0.7 kg
exenatide 5.0 microg b.i.d., day 28
Change in body weight
0 kg
placebo, day 28
Source sentences
Summary
In addition, patients receiving exenatide exhibited dose-dependent reductions in body weight (0.0 +/- 0.3, -0.7 +/- 0.3, -0.7 +/- 0.2, -1.4 +/- 0.3, and -1.8 +/- 0.3 kg for placebo and 2.5, 5.0, 7.5, and 10.0 microg b.i.d. exenatide, respectively; P < 0.01 for 7.5 and 10.0 microg b.i.d. exenatide do…
1 context sentence(design, population, supporting numbers)
Summary · context
In this randomized, triple-blinded, placebo-controlled Phase 2 clinical trial, 156 patients were randomized to placebo or exenatide at 2.5, 5.0, 7.5, or 10.0 microg administered b.i.d. for 28 days.
Report a problemFND-1592967812
13HumanRandomized controlled trialEfficacy outcome
In type 2 diabetes, exenatide reduced weight by 1.4 kg, significantly more than placebo.
In plain wordsPatients lost significantly more weight with exenatide than placebo.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseWeight change
Study
n: not reported in source
Comparator
Placebo
Outcome group
Body weight · Metabolic and weight
Studied dose
7.5 microg twice daily · 28 daysAs given in this study (human).
Measurements
Change in body weight
−1.4 kg
exenatide 7.5 microg b.i.d., day 28
Change in body weight
0 kg
placebo, day 28
Source sentences
Summary
In addition, patients receiving exenatide exhibited dose-dependent reductions in body weight (0.0 +/- 0.3, -0.7 +/- 0.3, -0.7 +/- 0.2, -1.4 +/- 0.3, and -1.8 +/- 0.3 kg for placebo and 2.5, 5.0, 7.5, and 10.0 microg b.i.d. exenatide, respectively; P < 0.01 for 7.5 and 10.0 microg b.i.d. exenatide do…
1 context sentence(design, population, supporting numbers)
Summary · context
In this randomized, triple-blinded, placebo-controlled Phase 2 clinical trial, 156 patients were randomized to placebo or exenatide at 2.5, 5.0, 7.5, or 10.0 microg administered b.i.d. for 28 days.
Report a problemFND-1592967813
14HumanRandomized controlled trialEfficacy outcome
In type 2 diabetes, exenatide reduced weight by 1.8 kg, significantly more than placebo.
In plain wordsPatients lost significantly more weight with exenatide than placebo.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseWeight change
Study
n: not reported in source
Comparator
Placebo
Outcome group
Body weight · Metabolic and weight
Studied dose
10.0 microg twice daily · 28 daysAs given in this study (human).
Measurements
Change in body weight
−1.8 kg
exenatide 10.0 microg b.i.d., day 28
Change in body weight
0 kg
placebo, day 28
Source sentences
Summary
In addition, patients receiving exenatide exhibited dose-dependent reductions in body weight (0.0 +/- 0.3, -0.7 +/- 0.3, -0.7 +/- 0.2, -1.4 +/- 0.3, and -1.8 +/- 0.3 kg for placebo and 2.5, 5.0, 7.5, and 10.0 microg b.i.d. exenatide, respectively; P < 0.01 for 7.5 and 10.0 microg b.i.d. exenatide do…
1 context sentence(design, population, supporting numbers)
Summary · context
In this randomized, triple-blinded, placebo-controlled Phase 2 clinical trial, 156 patients were randomized to placebo or exenatide at 2.5, 5.0, 7.5, or 10.0 microg administered b.i.d. for 28 days.
Report a problemFND-1592967814
15HumanRandomized controlled trialSafety outcome
In type 2 diabetes, mild-to-moderate nausea was the most common adverse event and increased with exenatide dose.
In plain wordsMild to moderate nausea was the most common adverse event and increased with exenatide dose.
Peptide
Exenatide (exendin-4)
Outcome
IncreaseNausea
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
Dose not stated · 28 daysAs given in this study (human).
Source sentences
Summary
The most common adverse event was mild-to-moderate nausea that was dose-dependent (seven of 123 patients randomized to exenatide withdrew from the study because of gastrointestinal effects).
1 context sentence(design, population, supporting numbers)
Summary · context
In this randomized, triple-blinded, placebo-controlled Phase 2 clinical trial, 156 patients were randomized to placebo or exenatide at 2.5, 5.0, 7.5, or 10.0 microg administered b.i.d. for 28 days.
Report a problemFND-1592967815

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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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