Study · Non-randomized trial · n = 283 · 2007

13 results

Metabolic effects of two years of exenatide treatment on diabetes, obesity, and hepatic biomarkers in patients with type 2 diabetes: an interim analysis of data from the open-label, uncontrolled extension of three double-blind, placebo-controlled trials.

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

Clinical therapeutics1 Jan 2007Cited by 194 (Europe PMC)

PMID17379054DOI10.1016/j.clinthera.2007.01.015PepBankPUB-17379054

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 study13

13 results from studies that gave the peptide. 13 results from people.

01HumanNon-randomized trialEfficacy outcome
In adults with T2DM, exenatide reduced HbA1c from baseline at week 30.
In plain wordsExenatide reduced blood sugar from baseline in adults with diabetes.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseHbA1c at week 30
Study
n = 283
Outcome group
Glycemic control · Metabolic and weight
Studied dose
Dose not stated · 30 weeksAs given in this study (human).
Measurements
HbA1c change
−0.9%
week 30
Source sentences
Summary
Reductions in mean (SE) HbA(1c) from baseline to week 30 (-0.9% [0.1%]) were sustained through 2 years (-1.1% [0.1%]; P < 0.05 vs baseline), with 50% of the population achieving HbA(1c) < or = 7%.
2 context sentences(design, population, supporting numbers)
Summary · context
For this interim analysis, data were pooled from patients who completed 1 of three 30-week, multicenter, double-blind, placebo-controlled trials and their open-label extensions.
Summary · context
Subjects continued their existing metformin and/or sulfonylurea regimens.
Report a problemFND-1737905401
02HumanNon-randomized trialEfficacy outcome
In adults with T2DM, HbA1c reductions persisted through two years of exenatide.
In plain wordsBlood sugar remained below baseline after two years of exenatide.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseHbA1c at two years
Study
n = 283
Outcome group
Glycemic control · Metabolic and weight
Studied dose
Dose not stated · 2 yearsAs given in this study (human).
Measurements
HbA1c change
−1.1%
2 years
Source sentences
Summary
Reductions in mean (SE) HbA(1c) from baseline to week 30 (-0.9% [0.1%]) were sustained through 2 years (-1.1% [0.1%]; P < 0.05 vs baseline), with 50% of the population achieving HbA(1c) < or = 7%.
2 context sentences(design, population, supporting numbers)
Summary · context
For this interim analysis, data were pooled from patients who completed 1 of three 30-week, multicenter, double-blind, placebo-controlled trials and their open-label extensions.
Summary · context
Subjects continued their existing metformin and/or sulfonylurea regimens.
Report a problemFND-1737905402
03HumanNon-randomized trialEfficacy outcome
In adults with T2DM, half achieved the reported HbA1c target during exenatide treatment.
In plain wordsHalf of the adults reached the reported blood sugar target during exenatide treatment.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableHbA1c target attainment
Study
n = 283
Outcome group
Glycemic control · Metabolic and weight
Studied dose
Dose not stated · 2 yearsAs given in this study (human).
Measurements
Target attainment
50%
HbA1c <=7%
Source sentences
Summary
Reductions in mean (SE) HbA(1c) from baseline to week 30 (-0.9% [0.1%]) were sustained through 2 years (-1.1% [0.1%]; P < 0.05 vs baseline), with 50% of the population achieving HbA(1c) < or = 7%.
2 context sentences(design, population, supporting numbers)
Summary · context
For this interim analysis, data were pooled from patients who completed 1 of three 30-week, multicenter, double-blind, placebo-controlled trials and their open-label extensions.
Summary · context
Subjects continued their existing metformin and/or sulfonylurea regimens.
Report a problemFND-1737905403
04HumanNon-randomized trialEfficacy outcome
In adults with T2DM, exenatide reduced body weight from baseline at week 30.
In plain wordsAdults weighed less than at baseline after exenatide treatment.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseWeight at week 30
Study
n = 283
Outcome group
Body weight · Metabolic and weight
Studied dose
Dose not stated · 30 weeksAs given in this study (human).
Measurements
Weight change
−2.1 kg
week 30
Source sentences
Summary
At week 30, exenatide was associated with a significant reduction in mean (SD) body weight from baseline (-2.1 [0.2] kg), with progressive reductions after 2 years (-4.7 [0.3] kg; P < 0.001 vs baseline).
2 context sentences(design, population, supporting numbers)
Summary · context
For this interim analysis, data were pooled from patients who completed 1 of three 30-week, multicenter, double-blind, placebo-controlled trials and their open-label extensions.
Summary · context
Subjects continued their existing metformin and/or sulfonylurea regimens.
Report a problemFND-1737905404
05HumanNon-randomized trialEfficacy outcome
In adults with T2DM, weight reductions progressed through two years of exenatide.
In plain wordsAdults continued to lose weight relative to baseline during two years of exenatide.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseWeight at two years
Study
n = 283
Outcome group
Body weight · Metabolic and weight
Studied dose
Dose not stated · 2 yearsAs given in this study (human).
Measurements
Weight change
−4.7 kg
2 years
Source sentences
Summary
At week 30, exenatide was associated with a significant reduction in mean (SD) body weight from baseline (-2.1 [0.2] kg), with progressive reductions after 2 years (-4.7 [0.3] kg; P < 0.001 vs baseline).
2 context sentences(design, population, supporting numbers)
Summary · context
For this interim analysis, data were pooled from patients who completed 1 of three 30-week, multicenter, double-blind, placebo-controlled trials and their open-label extensions.
Summary · context
Subjects continued their existing metformin and/or sulfonylurea regimens.
Report a problemFND-1737905405
06HumanNon-randomized trialEfficacy outcome
Exenatide-treated adults with elevated baseline ALT lost more weight than those with normal baseline ALT.
In plain wordsAdults with high starting ALT lost more weight than those with normal starting ALT during exenatide treatment.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseWeight loss by baseline ALT
Study
n = 283
Comparator
Normal baseline ALT
Outcome group
Body weight · Metabolic and weight
Studied dose
Dose not stated · 2 yearsAs given in this study (human).
Source sentences
Summary
Patients with elevated ALT at baseline lost significantly more weight than patients with normal ALT at baseline (P = 0.04).
2 context sentences(design, population, supporting numbers)
Summary · context
For this interim analysis, data were pooled from patients who completed 1 of three 30-week, multicenter, double-blind, placebo-controlled trials and their open-label extensions.
Summary · context
Subjects continued their existing metformin and/or sulfonylurea regimens.
Report a problemFND-1737905409
07HumanNon-randomized trialOther
In exenatide-treated adults, weight change correlated minimally with baseline ALT.
In plain wordsWeight change showed little relation to starting ALT in adults receiving exenatide.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableWeight change correlation with baseline ALT
Study
n = 283
Outcome group
Body weight · Metabolic and weight
Studied dose
Dose not stated · 2 yearsAs given in this study (human).
Measurements
Correlation
−0.09 r
baseline ALT and weight change
Source sentences
Summary
However, weight change was minimally correlated with baseline ALT (r = -0.09) or ALT change (r = 0.31).
2 context sentences(design, population, supporting numbers)
Summary · context
For this interim analysis, data were pooled from patients who completed 1 of three 30-week, multicenter, double-blind, placebo-controlled trials and their open-label extensions.
Summary · context
Subjects continued their existing metformin and/or sulfonylurea regimens.
Report a problemFND-1737905410
08HumanNon-randomized trialOther
In exenatide-treated adults, weight change correlated minimally with ALT change.
In plain wordsWeight change showed little relation to ALT change in adults receiving exenatide.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableWeight change correlation with ALT change
Study
n = 283
Outcome group
Body weight · Metabolic and weight
Studied dose
Dose not stated · 2 yearsAs given in this study (human).
Measurements
Correlation
0.31 r
ALT change and weight change
Source sentences
Summary
However, weight change was minimally correlated with baseline ALT (r = -0.09) or ALT change (r = 0.31).
2 context sentences(design, population, supporting numbers)
Summary · context
For this interim analysis, data were pooled from patients who completed 1 of three 30-week, multicenter, double-blind, placebo-controlled trials and their open-label extensions.
Summary · context
Subjects continued their existing metformin and/or sulfonylurea regimens.
Report a problemFND-1737905411
09HumanNon-randomized trialEfficacy outcome
In adults with T2DM, HOMA-B, blood pressure, and AST improved during the uncontrolled exenatide extension.
In plain wordsDuring the uncontrolled exenatide extension, a cell-function measure, blood pressure, and liver enzyme AST improved.
Peptide
Exenatide (exendin-4)
Outcome
Direction not reportedHOMA-B, blood pressure, and AST
Study
n = 283
Outcome group
Glycemic control · Metabolic and weight
Studied dose
Dose not stated · 2 yearsAs given in this study (human).
Source sentences
Summary
Also, homeostasis model assessment of the beta-cell function (HOMA-B), blood pressure, and aspartate aminotransferase (AST) all improved.
2 context sentences(design, population, supporting numbers)
Summary · context
For this interim analysis, data were pooled from patients who completed 1 of three 30-week, multicenter, double-blind, placebo-controlled trials and their open-label extensions.
Summary · context
Subjects continued their existing metformin and/or sulfonylurea regimens.
Report a problemFND-1737905412
10HumanNon-randomized trialSafety outcome
In adults with T2DM, mild-to-moderate nausea was the most frequent reported adverse event during exenatide treatment.
In plain wordsMild-to-moderate nausea was the most frequent reported side effect during exenatide treatment.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableNausea
Study
n = 283
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
Dose not stated · 2 yearsAs given in this study (human).
Source sentences
Summary
The most frequently reported adverse event was mild-to-moderate nausea.
2 context sentences(design, population, supporting numbers)
Summary · context
For this interim analysis, data were pooled from patients who completed 1 of three 30-week, multicenter, double-blind, placebo-controlled trials and their open-label extensions.
Summary · context
Subjects continued their existing metformin and/or sulfonylurea regimens.
Report a problemFND-1737905413
11HumanNon-randomized trialEfficacy outcome
In adults with elevated baseline ALT, ALT decreased during exenatide treatment.
In plain wordsLiver enzyme ALT decreased from baseline in adults whose starting ALT was high.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseALT with elevated baseline ALT
Study
n = 151
Outcome group
Liver fat and liver function · Liver
Studied dose
Dose not stated · 2 yearsAs given in this study (human).
Measurements
ALT change
−11 IU/L
elevated baseline ALT
Source sentences
Summary
However, patients with elevated ALT at baseline (151/283 [53%]) had a mean (SEM) reduction of ALT (-11 [1] IU/L from baseline 38 [1] IU/1; P < 0.05) and 39% achieved normal ALT by week 104.
2 context sentences(design, population, supporting numbers)
Summary · context
For this interim analysis, data were pooled from patients who completed 1 of three 30-week, multicenter, double-blind, placebo-controlled trials and their open-label extensions.
Summary · context
Subjects continued their existing metformin and/or sulfonylurea regimens.
Report a problemFND-1737905407
12HumanNon-randomized trialEfficacy outcome
In adults with elevated baseline ALT, some achieved normal ALT by week 104 during exenatide treatment.
In plain wordsSome adults with high starting ALT reached normal ALT during exenatide treatment.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableALT normalization
Study
n = 151
Outcome group
Liver fat and liver function · Liver
Studied dose
Dose not stated · 2 yearsAs given in this study (human).
Measurements
ALT normalization
39%
week 104
Source sentences
Summary
However, patients with elevated ALT at baseline (151/283 [53%]) had a mean (SEM) reduction of ALT (-11 [1] IU/L from baseline 38 [1] IU/1; P < 0.05) and 39% achieved normal ALT by week 104.
2 context sentences(design, population, supporting numbers)
Summary · context
For this interim analysis, data were pooled from patients who completed 1 of three 30-week, multicenter, double-blind, placebo-controlled trials and their open-label extensions.
Summary · context
Subjects continued their existing metformin and/or sulfonylurea regimens.
Report a problemFND-1737905408
13HumanNon-randomized trialEfficacy outcome
In adults with normal baseline ALT, ALT did not change significantly during exenatide treatment.
In plain wordsLiver enzyme ALT did not change significantly in adults whose starting ALT was normal.
Peptide
Exenatide (exendin-4)
Outcome
No significant changeALT with normal baseline ALT
Study
n = 132
Outcome group
Liver fat and liver function · Liver
Studied dose
Dose not stated · 2 yearsAs given in this study (human).
Source sentences
Summary
Patients with normal baseline alanine aminotransferase (ALT) (132/283 [47%]; normal: female < or =19 IU/L; male < or =30 IU/L) had no significant ALT change.
2 context sentences(design, population, supporting numbers)
Summary · context
For this interim analysis, data were pooled from patients who completed 1 of three 30-week, multicenter, double-blind, placebo-controlled trials and their open-label extensions.
Summary · context
Subjects continued their existing metformin and/or sulfonylurea regimens.
Report a problemFND-1737905406

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials4

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

4 trials · 3 completed · 1 stopped early · 3 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT01722266

Liraglutide in the Treatment of Type 1 Diabetes Mellitus

University at Buffalon = 721 Nov 2012 to 1 Dec 2014

Type 1 Diabetes

Trial page ClinicalTrials.govUpdated 5 Jan 2024

CompletedPhase 3Results postedNCT00856609

The Effects of Exenatide (Byetta ) on Energy Expenditure and Weight Loss in Nondiabetic Obese Subjects

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)n = 1503 Mar 2009 to 19 Sept 2016

Weight Loss · Obesity

Trial page ClinicalTrials.govUpdated 4 Jun 2019

TerminatedPhase 2Results postedNCT00529204

Effects Of Exenatide On Liver Biochemistry, Liver Histology And Lipid Metabolism In Patients With Fatty Liver Disease

University of California, Davisn = 1Oct 2007 to Feb 2010

Diabetes Complications · Fatty Liver

Trial page ClinicalTrials.govUpdated 20 Jun 2017

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

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