Exenatide effects on diabetes, obesity, cardiovascular risk factors and hepatic biomarkers in patients with type 2 diabetes treated for at least 3 years.

Klonoff DC, Buse JB, Nielsen LL, Guan X, Bowlus CL, Holcombe JH, Wintle ME, Maggs DG

Current medical research and opinion1 Jan 2008Cited by 508 (Europe PMC)

PMID18053320DOI10.1185/030079908x253870PepBankPUB-18053320

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 study16

16 results from studies that gave the peptide. 16 results from people.

01HumanNon-randomized trialEfficacy outcome
In type 2 diabetes, exenatide reduced A1C by 1.1% from baseline at week 12.
In plain wordsIn type 2 diabetes, exenatide reduced A1C from baseline at week 12.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseA1C at week 12
Study
n = 217
Comparator
Baseline
Outcome group
Glycemic control · Metabolic and weight
Studied dose
Dose not stated · 12 weeksAs given in this study (human).
Measurements
A1C change from baseline
−1.1%
week 12
Source sentences
Summary
Reductions in A1C from baseline to week 12 (-1.1 +/- 0.1% [mean +/- SEM]) were sustained to 3 years (-1.0 +/- 0.1%; p < 0.0001), with 46% achieving A1C < or = 7%.
3 context sentences(design, population, supporting numbers)
Summary · context
Patients from three placebo-controlled trials and their open-label extensions were enrolled into one open-ended, open-label clinical trial.
Summary · context
Patients were randomized to twice daily (BID) placebo, 5 mug exenatide, or 10 mug exenatide for 30 weeks, followed by 5 mug exenatide BID for 4 weeks, then 10 mug exenatide BID for > or = 3 years of exenatide exposure.
Summary · context
Patients continued metformin and/or sulfonylureas.
Report a problemFND-1805332001
02HumanNon-randomized trialEfficacy outcome
In type 2 diabetes, exenatide sustained an A1C reduction of 1.0% from baseline at 3 years.
In plain wordsIn type 2 diabetes, A1C remained below baseline after 3 years of exenatide.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseA1C at 3 years
Study
n = 217
Comparator
Baseline
Outcome group
Glycemic control · Metabolic and weight
Studied dose
10 mug twice daily after titration · 3 yearsAs given in this study (human).
Measurements
A1C change from baseline
−1%
3 years
Source sentences
Summary
Reductions in A1C from baseline to week 12 (-1.1 +/- 0.1% [mean +/- SEM]) were sustained to 3 years (-1.0 +/- 0.1%; p < 0.0001), with 46% achieving A1C < or = 7%.
3 context sentences(design, population, supporting numbers)
Summary · context
Patients from three placebo-controlled trials and their open-label extensions were enrolled into one open-ended, open-label clinical trial.
Summary · context
Patients were randomized to twice daily (BID) placebo, 5 mug exenatide, or 10 mug exenatide for 30 weeks, followed by 5 mug exenatide BID for 4 weeks, then 10 mug exenatide BID for > or = 3 years of exenatide exposure.
Summary · context
Patients continued metformin and/or sulfonylureas.
Report a problemFND-1805332002
03HumanNon-randomized trialEfficacy outcome
In type 2 diabetes, 46% of exenatide recipients achieved A1C <=7% after long-term exposure.
In plain wordsIn type 2 diabetes, 46% of exenatide recipients reached the reported A1C target.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableA1C target attainment
Study
n = 217
Outcome group
Glycemic control · Metabolic and weight
Studied dose
10 mug twice daily after titration · 3 yearsAs given in this study (human).
Measurements
Proportion achieving A1C <=7%
46%
exenatide recipients
Source sentences
Summary
Reductions in A1C from baseline to week 12 (-1.1 +/- 0.1% [mean +/- SEM]) were sustained to 3 years (-1.0 +/- 0.1%; p < 0.0001), with 46% achieving A1C < or = 7%.
3 context sentences(design, population, supporting numbers)
Summary · context
Patients from three placebo-controlled trials and their open-label extensions were enrolled into one open-ended, open-label clinical trial.
Summary · context
Patients were randomized to twice daily (BID) placebo, 5 mug exenatide, or 10 mug exenatide for 30 weeks, followed by 5 mug exenatide BID for 4 weeks, then 10 mug exenatide BID for > or = 3 years of exenatide exposure.
Summary · context
Patients continued metformin and/or sulfonylureas.
Report a problemFND-1805332003
04HumanNon-randomized trialEfficacy outcome
In type 2 diabetes, exenatide reduced body weight by 5.3 kg from baseline at 3 years.
In plain wordsIn type 2 diabetes, body weight fell from baseline during 3 years of exenatide.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseBody weight
Study
n = 217
Comparator
Baseline
Outcome group
Body weight · Metabolic and weight
Studied dose
10 mug twice daily after titration · 3 yearsAs given in this study (human).
Measurements
Body weight change from baseline
−5.3 kg
3 years
Source sentences
Summary
Exenatide progressively reduced body weight from baseline (-5.3 +/- 0.4 kg at 3 years; p < 0.0001).
3 context sentences(design, population, supporting numbers)
Summary · context
Patients from three placebo-controlled trials and their open-label extensions were enrolled into one open-ended, open-label clinical trial.
Summary · context
Patients were randomized to twice daily (BID) placebo, 5 mug exenatide, or 10 mug exenatide for 30 weeks, followed by 5 mug exenatide BID for 4 weeks, then 10 mug exenatide BID for > or = 3 years of exenatide exposure.
Summary · context
Patients continued metformin and/or sulfonylureas.
Report a problemFND-1805332004
05HumanNon-randomized trialEfficacy outcome
In type 2 diabetes, long-term exenatide treatment improved HOMA-B, blood pressure, and AST without separate result estimates.
In plain wordsIn type 2 diabetes, exenatide treatment improved reported pancreatic, blood pressure, and liver markers.
Peptide
Exenatide (exendin-4)
Outcome
MixedHOMA-B, blood pressure, and AST
Study
n = 217
Comparator
Baseline
Outcome group
Cardiometabolic risk factors · Metabolic and weight
Studied dose
10 mug twice daily after titration · 3 yearsAs given in this study (human).
Source sentences
Summary
Homeostasis Model Assessment B (HOMA-B), blood pressure, and aspartate aminotransferase (AST) all improved.
3 context sentences(design, population, supporting numbers)
Summary · context
Patients from three placebo-controlled trials and their open-label extensions were enrolled into one open-ended, open-label clinical trial.
Summary · context
Patients were randomized to twice daily (BID) placebo, 5 mug exenatide, or 10 mug exenatide for 30 weeks, followed by 5 mug exenatide BID for 4 weeks, then 10 mug exenatide BID for > or = 3 years of exenatide exposure.
Summary · context
Patients continued metformin and/or sulfonylureas.
Report a problemFND-1805332010
06HumanNon-randomized trialSafety outcome
In type 2 diabetes, long-term exenatide was generally well tolerated.
In plain wordsIn type 2 diabetes, patients generally tolerated long-term exenatide.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableGeneral tolerability
Study
n = 217
Outcome group
Adverse events · Whole body
Studied dose
10 mug twice daily after titration · 3 yearsAs given in this study (human).
Source sentences
Summary
Exenatide was generally well tolerated.
3 context sentences(design, population, supporting numbers)
Summary · context
Patients from three placebo-controlled trials and their open-label extensions were enrolled into one open-ended, open-label clinical trial.
Summary · context
Patients were randomized to twice daily (BID) placebo, 5 mug exenatide, or 10 mug exenatide for 30 weeks, followed by 5 mug exenatide BID for 4 weeks, then 10 mug exenatide BID for > or = 3 years of exenatide exposure.
Summary · context
Patients continued metformin and/or sulfonylureas.
Report a problemFND-1805332015
07HumanNon-randomized trialSafety outcome
In type 2 diabetes patients receiving long-term exenatide, mild-to-moderate nausea was the most frequent adverse event.
In plain wordsIn type 2 diabetes patients receiving exenatide, mild-to-moderate nausea was the most common adverse event.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableNausea
Study
n = 217
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
10 mug twice daily after titration · 3 yearsAs given in this study (human).
Source sentences
Summary
The most frequent adverse event was mild-to-moderate nausea.
3 context sentences(design, population, supporting numbers)
Summary · context
Patients from three placebo-controlled trials and their open-label extensions were enrolled into one open-ended, open-label clinical trial.
Summary · context
Patients were randomized to twice daily (BID) placebo, 5 mug exenatide, or 10 mug exenatide for 30 weeks, followed by 5 mug exenatide BID for 4 weeks, then 10 mug exenatide BID for > or = 3 years of exenatide exposure.
Summary · context
Patients continued metformin and/or sulfonylureas.
Report a problemFND-1805332016
08HumanNon-randomized trialEfficacy outcome
In type 2 diabetes patients with available lipids, exenatide reduced triglycerides by 12% from baseline.
In plain wordsIn type 2 diabetes patients with lipid measurements, triglycerides fell from baseline during exenatide treatment.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseTriglycerides
Study
n = 151
Comparator
Baseline
Outcome group
Lipids · Metabolic and weight
Studied dose
10 mug twice daily after titration · 3.5 yearsAs given in this study (human).
Measurements
Triglycerides decrease
12%
lipid subset (n = 151)
Source sentences
Summary
Triglycerides decreased 12% (p = 0.0003), total cholesterol decreased 5% (p = 0.0007), LDL-C decreased 6% (p < 0.0001), and HDL-C increased 24% (p < 0.0001).
4 context sentences(design, population, supporting numbers)
Summary · context
A subset achieved 3.5 years of exenatide exposure and had serum lipids available for analysis (n = 151).
Summary · context
Patients from three placebo-controlled trials and their open-label extensions were enrolled into one open-ended, open-label clinical trial.
Summary · context
Patients were randomized to twice daily (BID) placebo, 5 mug exenatide, or 10 mug exenatide for 30 weeks, followed by 5 mug exenatide BID for 4 weeks, then 10 mug exenatide BID for > or = 3 years of exenatide exposure.
Summary · context
Patients continued metformin and/or sulfonylureas.
Report a problemFND-1805332011
09HumanNon-randomized trialEfficacy outcome
In type 2 diabetes patients with available lipids, exenatide reduced total cholesterol by 5% from baseline.
In plain wordsIn type 2 diabetes patients with lipid measurements, total cholesterol fell from baseline during exenatide treatment.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseTotal cholesterol
Study
n = 151
Comparator
Baseline
Outcome group
Lipids · Metabolic and weight
Studied dose
10 mug twice daily after titration · 3.5 yearsAs given in this study (human).
Measurements
Total cholesterol decrease
5%
lipid subset (n = 151)
Source sentences
Summary
Triglycerides decreased 12% (p = 0.0003), total cholesterol decreased 5% (p = 0.0007), LDL-C decreased 6% (p < 0.0001), and HDL-C increased 24% (p < 0.0001).
4 context sentences(design, population, supporting numbers)
Summary · context
A subset achieved 3.5 years of exenatide exposure and had serum lipids available for analysis (n = 151).
Summary · context
Patients from three placebo-controlled trials and their open-label extensions were enrolled into one open-ended, open-label clinical trial.
Summary · context
Patients were randomized to twice daily (BID) placebo, 5 mug exenatide, or 10 mug exenatide for 30 weeks, followed by 5 mug exenatide BID for 4 weeks, then 10 mug exenatide BID for > or = 3 years of exenatide exposure.
Summary · context
Patients continued metformin and/or sulfonylureas.
Report a problemFND-1805332012
10HumanNon-randomized trialEfficacy outcome
In type 2 diabetes patients with available lipids, exenatide reduced LDL-C by 6% from baseline.
In plain wordsIn type 2 diabetes patients with lipid measurements, LDL cholesterol fell from baseline during exenatide treatment.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseLDL cholesterol
Study
n = 151
Comparator
Baseline
Outcome group
Lipids · Metabolic and weight
Studied dose
10 mug twice daily after titration · 3.5 yearsAs given in this study (human).
Measurements
LDL-C decrease
6%
lipid subset (n = 151)
Source sentences
Summary
Triglycerides decreased 12% (p = 0.0003), total cholesterol decreased 5% (p = 0.0007), LDL-C decreased 6% (p < 0.0001), and HDL-C increased 24% (p < 0.0001).
4 context sentences(design, population, supporting numbers)
Summary · context
A subset achieved 3.5 years of exenatide exposure and had serum lipids available for analysis (n = 151).
Summary · context
Patients from three placebo-controlled trials and their open-label extensions were enrolled into one open-ended, open-label clinical trial.
Summary · context
Patients were randomized to twice daily (BID) placebo, 5 mug exenatide, or 10 mug exenatide for 30 weeks, followed by 5 mug exenatide BID for 4 weeks, then 10 mug exenatide BID for > or = 3 years of exenatide exposure.
Summary · context
Patients continued metformin and/or sulfonylureas.
Report a problemFND-1805332013
11HumanNon-randomized trialEfficacy outcome
In type 2 diabetes patients with available lipids, exenatide increased HDL-C by 24% from baseline.
In plain wordsIn type 2 diabetes patients with lipid measurements, HDL cholesterol rose from baseline during exenatide treatment.
Peptide
Exenatide (exendin-4)
Outcome
IncreaseHDL cholesterol
Study
n = 151
Comparator
Baseline
Outcome group
Lipids · Metabolic and weight
Studied dose
10 mug twice daily after titration · 3.5 yearsAs given in this study (human).
Measurements
HDL-C increase
24%
lipid subset (n = 151)
Source sentences
Summary
Triglycerides decreased 12% (p = 0.0003), total cholesterol decreased 5% (p = 0.0007), LDL-C decreased 6% (p < 0.0001), and HDL-C increased 24% (p < 0.0001).
4 context sentences(design, population, supporting numbers)
Summary · context
A subset achieved 3.5 years of exenatide exposure and had serum lipids available for analysis (n = 151).
Summary · context
Patients from three placebo-controlled trials and their open-label extensions were enrolled into one open-ended, open-label clinical trial.
Summary · context
Patients were randomized to twice daily (BID) placebo, 5 mug exenatide, or 10 mug exenatide for 30 weeks, followed by 5 mug exenatide BID for 4 weeks, then 10 mug exenatide BID for > or = 3 years of exenatide exposure.
Summary · context
Patients continued metformin and/or sulfonylureas.
Report a problemFND-1805332014
12HumanNon-randomized trialEfficacy outcome
In exenatide recipients with elevated baseline ALT, ALT decreased by 10.4 IU/L from baseline.
In plain wordsIn patients with high baseline ALT, this liver enzyme fell during exenatide treatment.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseALT in elevated baseline subgroup
Study
n = 116
Comparator
Baseline
Outcome group
Liver fat and liver function · Liver
Studied dose
10 mug twice daily after titration · 3 yearsAs given in this study (human).
Measurements
ALT change from baseline
−10.4 IU/L
elevated baseline ALT (n = 116)
Source sentences
Summary
Patients with elevated serum alanine aminotransferase (ALT) at baseline (n = 116) had reduced ALT (-10.4 +/- 1.5 IU/L; p < 0.0001) and 41% achieved normal ALT.
3 context sentences(design, population, supporting numbers)
Summary · context
Patients from three placebo-controlled trials and their open-label extensions were enrolled into one open-ended, open-label clinical trial.
Summary · context
Patients were randomized to twice daily (BID) placebo, 5 mug exenatide, or 10 mug exenatide for 30 weeks, followed by 5 mug exenatide BID for 4 weeks, then 10 mug exenatide BID for > or = 3 years of exenatide exposure.
Summary · context
Patients continued metformin and/or sulfonylureas.
Report a problemFND-1805332005
13HumanNon-randomized trialEfficacy outcome
Among exenatide recipients with elevated baseline ALT, 41% achieved normal ALT.
In plain wordsAmong patients with high baseline ALT, 41% reached normal levels during exenatide treatment.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableALT normalization
Study
n = 116
Outcome group
Liver fat and liver function · Liver
Studied dose
10 mug twice daily after titration · 3 yearsAs given in this study (human).
Measurements
Proportion achieving normal ALT
41%
elevated baseline ALT
Source sentences
Summary
Patients with elevated serum alanine aminotransferase (ALT) at baseline (n = 116) had reduced ALT (-10.4 +/- 1.5 IU/L; p < 0.0001) and 41% achieved normal ALT.
3 context sentences(design, population, supporting numbers)
Summary · context
Patients from three placebo-controlled trials and their open-label extensions were enrolled into one open-ended, open-label clinical trial.
Summary · context
Patients were randomized to twice daily (BID) placebo, 5 mug exenatide, or 10 mug exenatide for 30 weeks, followed by 5 mug exenatide BID for 4 weeks, then 10 mug exenatide BID for > or = 3 years of exenatide exposure.
Summary · context
Patients continued metformin and/or sulfonylureas.
Report a problemFND-1805332006
14HumanNon-randomized trialEfficacy outcome
Exenatide recipients with elevated baseline ALT lost more weight than those with normal baseline ALT.
In plain wordsDuring exenatide treatment, patients with high baseline ALT lost more weight than patients with normal baseline ALT.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseWeight loss by baseline ALT
Study
n: not reported in source
Comparator
Normal baseline ALT subgroup
Outcome group
Body weight · Metabolic and weight
Studied dose
10 mug twice daily after titration · 3 yearsAs given in this study (human).
Measurements
Weight change
−6.1 kg
elevated baseline ALT
Weight change
−4.4 kg
normal baseline ALT
Source sentences
Summary
Patients with elevated ALT at baseline tended to lose more weight than patients with normal ALT at baseline (-6.1 +/- 0.6 kg vs. -4.4 +/- 0.5 kg; p = 0.03), however weight change was minimally correlated with baseline ALT (r = -0.01) or ALT change (r = 0.31).
3 context sentences(design, population, supporting numbers)
Summary · context
Patients from three placebo-controlled trials and their open-label extensions were enrolled into one open-ended, open-label clinical trial.
Summary · context
Patients were randomized to twice daily (BID) placebo, 5 mug exenatide, or 10 mug exenatide for 30 weeks, followed by 5 mug exenatide BID for 4 weeks, then 10 mug exenatide BID for > or = 3 years of exenatide exposure.
Summary · context
Patients continued metformin and/or sulfonylureas.
Report a problemFND-1805332007
15HumanNon-randomized trialOther
In exenatide recipients, weight change correlated minimally with baseline ALT, with r = -0.01.
In plain wordsDuring exenatide treatment, weight change had little association with baseline ALT.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableWeight change correlation with baseline ALT
Study
n: not reported in source
Outcome group
Body weight · Metabolic and weight
Studied dose
10 mug twice daily after titration · 3 yearsAs given in this study (human).
Measurements
Correlation of weight change with baseline ALT
−0.01 r
exenatide recipients
Source sentences
Summary
Patients with elevated ALT at baseline tended to lose more weight than patients with normal ALT at baseline (-6.1 +/- 0.6 kg vs. -4.4 +/- 0.5 kg; p = 0.03), however weight change was minimally correlated with baseline ALT (r = -0.01) or ALT change (r = 0.31).
3 context sentences(design, population, supporting numbers)
Summary · context
Patients from three placebo-controlled trials and their open-label extensions were enrolled into one open-ended, open-label clinical trial.
Summary · context
Patients were randomized to twice daily (BID) placebo, 5 mug exenatide, or 10 mug exenatide for 30 weeks, followed by 5 mug exenatide BID for 4 weeks, then 10 mug exenatide BID for > or = 3 years of exenatide exposure.
Summary · context
Patients continued metformin and/or sulfonylureas.
Report a problemFND-1805332008
16HumanNon-randomized trialOther
In exenatide recipients, weight change correlated minimally with ALT change, with r = 0.31.
In plain wordsDuring exenatide treatment, weight change had a limited association with ALT change.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableWeight change correlation with ALT change
Study
n: not reported in source
Outcome group
Body weight · Metabolic and weight
Studied dose
10 mug twice daily after titration · 3 yearsAs given in this study (human).
Measurements
Correlation of weight change with ALT change
0.31 r
exenatide recipients
Source sentences
Summary
Patients with elevated ALT at baseline tended to lose more weight than patients with normal ALT at baseline (-6.1 +/- 0.6 kg vs. -4.4 +/- 0.5 kg; p = 0.03), however weight change was minimally correlated with baseline ALT (r = -0.01) or ALT change (r = 0.31).
3 context sentences(design, population, supporting numbers)
Summary · context
Patients from three placebo-controlled trials and their open-label extensions were enrolled into one open-ended, open-label clinical trial.
Summary · context
Patients were randomized to twice daily (BID) placebo, 5 mug exenatide, or 10 mug exenatide for 30 weeks, followed by 5 mug exenatide BID for 4 weeks, then 10 mug exenatide BID for > or = 3 years of exenatide exposure.
Summary · context
Patients continued metformin and/or sulfonylureas.
Report a problemFND-1805332009

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 3NCT00111540

Study to Examine the Effect on Glucose Control and Safety/Tolerability of Exenatide Given Two Times a Day to Subjects With Type 2 Diabetes

AstraZenecan = 456Nov 2002 to Sept 2006

Diabetes Mellitus, Type 2

Trial page ClinicalTrials.govUpdated 23 Feb 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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