Trial · NCT00375492

Effect on Weight Loss of Exenatide Versus Placebo

NCT00375492, Phase 3, Completed, AstraZeneca; results first posted 2009-09-04

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Effect on Weight Loss of Exenatide Versus Placebo. Trials, record NCT00375492. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00375492

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Effect on Weight Loss of Exenatide Versus Placebo
NCT number: NCT00375492
Status: Completed
Phases: Phase 3
Enrollment: 196 participants, actual
Lead sponsor: AstraZeneca
Conditions: Type 2 Diabetes Mellitus
Interventions: exenatide, placebo
First posted: 2006-09-13
Last updated: 2015-04-07
Results first posted: 2009-09-04

Source ClinicalTrials.gov

Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in Body Weight	Baseline, Week 24	Change in body weight from baseline (Week 0) after 24 weeks of treatment (i.e., weight at week 24 minus weight at week 0). Body weight measured in kilograms (k).
Secondary	Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24	baseline, Week 24	Change in HbA1c from baseline (Week 0) after 24 weeks of treatment (i.e., HbA1c at week 24 minus HbA1c at week 0). HbA1c is measured as percent (%) of hemoglobin.
Secondary	Change From Baseline in 6-point Self Monitored Blood Glucose (SMBG) Profile at Week 24	baseline, Week 24	Change in SMBG at each of 6 time points throughout a day (blood glucose measurements before and 2 hours after the start of the morning, mid-day, and evening meals); week 24 compared to week 0 (i.e., SMBG at week 24 minus SMBG at week 0). Fasting Glucose measured in millimoles per liter (mmol/L).
Secondary	Change From Baseline in Waist Circumference at Week 24	baseline, Week 24	Change in waist circumference from baseline after 24 weeks of treatment (i.e., waist circumference at week 24 minus waist circumference at week 0). Waist measured in centimeters (cm).
Secondary	Ratio of Homeostatic Model Assessment-Beta Cell (HOMA-B) at Week 24 to HOMA-B at Baseline	baseline, Week 24	Ratio of HOMA-B at Week 24 to HOMA-B at baseline (Week 0). HOMA-B is a computer solved model used to predict the homeostatic concentrations which arise from varying degrees beta-cell deficiency. HOMA-B allows a quantitative assessment of the contributions of deficient beta cell function to the fasting hyperglycemia. HOMA-B is measured as a percent of the normal population (normal beta cell function = 100%, which is used as a reference in the calculation). The higher the percent the better for the participant.
Secondary	Ratio of Homeostatic Model Assessment-Insulin Sensitivity (HOMA-S) at Week 24 to HOMA-S at Baseline	baseline, Week 24	Ratio of HOMA-S at Week 24 to HOMA-S at baseline, week 0. HOMA-S is a computer solved model used to predict the homeostatic concentrations which arise from varying degrees of insulin sensitivity. HOMA-S allows a quantitative assessment of the contributions of insulin sensitivity to the fasting hyperglycemia. HOMA-S is measured as a percent of the normal population (normal insulin sensitivity = 100%, which is used as a reference in the calculation). The higher the percent the better for the participant.
Secondary	Change From Baseline in High Density Lipoprotein (HDL) Cholesterol at Week 24	baseline, Week 24	Change in HDL cholesterol from baseline after 24 weeks of treatment (i.e., HDL cholesterol at week 24 minus HDL cholesterol at week 0). HDL measured as mmol/L.
Secondary	Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol at Week 24	baseline, Week 24	Change in LDL cholesterol from baseline (Week 0) after 24 weeks of treatment (ie., LDL cholesterol at week 24 minus LDL cholesterol at week 0). LDL cholesterol measured in mmol/L
Secondary	Change From Baseline in Total Cholesterol at Week 24	baseline, week 24	Change in total cholesterol from baseline after 24 weeks of treatment (i.e., total cholesterol at week 24 minus total cholesterol at week 0). Total cholesterol measured in mmol/L.
Secondary	Ratio of Triglycerides at Week 24 to Triglycerides at Baseline	baseline, Week 24	Ratio of triglyceride levels at Week 24 to triglyceride levels at baseline, Week 0 (ie., triglycerides at Week 24 divided by triglycerides at baseline, Week 0). Triglycerides measured in mmol/L.

1 to 10 of 12Source ClinicalTrials.gov

See all 12 registered outcomes

Outcomes12

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Body Weight	Baseline, Week 24	Intent to Treat population	kg	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24	baseline, Week 24	Intent to Treat population	percent hemoglobin	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in 6-point Self Monitored Blood Glucose (SMBG) Profile at Week 24	baseline, Week 24	Intent to Treat population	mmol/L	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Waist Circumference at Week 24	baseline, Week 24	Intent to Treat population	cm	LEAST_SQUARES_MEAN
SECONDARY	Ratio of Homeostatic Model Assessment-Beta Cell (HOMA-B) at Week 24 to HOMA-B at Baseline	baseline, Week 24	Intent to Treat population	Ratio	GEOMETRIC_MEAN
SECONDARY	Ratio of Homeostatic Model Assessment-Insulin Sensitivity (HOMA-S) at Week 24 to HOMA-S at Baseline	baseline, Week 24	Intent to Treat population	Ratio	GEOMETRIC_MEAN
SECONDARY	Change From Baseline in High Density Lipoprotein (HDL) Cholesterol at Week 24	baseline, Week 24	Intent to Treat population	mmol/L	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol at Week 24	baseline, Week 24	Intent to Treat population	mmol/L	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Total Cholesterol at Week 24	baseline, week 24	Intent to Treat population	mmol/L	LEAST_SQUARES_MEAN
SECONDARY	Ratio of Triglycerides at Week 24 to Triglycerides at Baseline	baseline, Week 24	Intent to Treat population	Ratio	GEOMETRIC_MEAN

1 to 10 of 12Source ClinicalTrials.gov

See all 12 outcomes

Results by group34

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change From Baseline in Body Weight	Group A (Exenatide)		-6.16	Standard Error 0.54	kg
Change From Baseline in Body Weight	Group B (Placebo)		-3.97	Standard Error 0.52	kg
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24	Group A (Exenatide)		-1.21	Standard Error 0.09	percent hemoglobin
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24	Group B (Placebo)		-0.73	Standard Error 0.09	percent hemoglobin
Change From Baseline in 6-point Self Monitored Blood Glucose (SMBG) Profile at Week 24	Group A (Exenatide)	Morning Pre-Meal	-1.87	Standard Error 0.17	mmol/L
Change From Baseline in 6-point Self Monitored Blood Glucose (SMBG) Profile at Week 24	Group B (Placebo)	Morning Pre-Meal	-1.20	Standard Error 0.17	mmol/L
Change From Baseline in 6-point Self Monitored Blood Glucose (SMBG) Profile at Week 24	Group A (Exenatide)	2 Hours Post Morning Meal	-2.67	Standard Error 0.22	mmol/L
Change From Baseline in 6-point Self Monitored Blood Glucose (SMBG) Profile at Week 24	Group B (Placebo)	2 Hours Post Morning Meal	-1.92	Standard Error 0.22	mmol/L
Change From Baseline in 6-point Self Monitored Blood Glucose (SMBG) Profile at Week 24	Group A (Exenatide)	Midday Pre-Meal	-1.40	Standard Error 0.19	mmol/L
Change From Baseline in 6-point Self Monitored Blood Glucose (SMBG) Profile at Week 24	Group B (Placebo)	Midday Pre-Meal	-1.37	Standard Error 0.19	mmol/L

1 to 10 of 34Source ClinicalTrials.gov

See all 34 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Group A (Exenatide)	96
Overall Study	STARTED	Group B (Placebo)	98
Overall Study	COMPLETED	Group A (Exenatide)	70
Overall Study	COMPLETED	Group B (Placebo)	72
Overall Study	NOT COMPLETED	Group A (Exenatide)	26
Overall Study	NOT COMPLETED	Group B (Placebo)	26

Source ClinicalTrials.gov

Adverse events50

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Nausea	Gastrointestinal disorders	Group A (Exenatide)	43	96
other	Nausea	Gastrointestinal disorders	Group B (Placebo)	19	98
other	Diarrhea	Gastrointestinal disorders	Group A (Exenatide)	18	96
other	Diarrhea	Gastrointestinal disorders	Group B (Placebo)	21	98
other	Upper respiratory tract infection	Infections and infestations	Group A (Exenatide)	17	96
other	Upper respiratory tract infection	Infections and infestations	Group B (Placebo)	17	98
other	Vomiting	Gastrointestinal disorders	Group A (Exenatide)	21	96
other	Vomiting	Gastrointestinal disorders	Group B (Placebo)	9	98
other	Headache	Nervous system disorders	Group A (Exenatide)	11	96
other	Headache	Nervous system disorders	Group B (Placebo)	9	98

1 to 10 of 50Source ClinicalTrials.gov

See all 50 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected
Total, all-cause mortality	Group A (Exenatide)
Total, all-cause mortality	Group B (Placebo)
Total, other adverse events	Group A (Exenatide)	87
Total, other adverse events	Group B (Placebo)	82
Total, serious adverse events	Group A (Exenatide)	2
Total, serious adverse events	Group B (Placebo)	2

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
22913891	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Group A (Exenatide) vs Group B (Placebo): Number of Participants With Hypoglycemic Events During the Study

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00375492

GET https://conductscience.org/api/trials/v1/NCT00375492/results?page=2

API reference For AI assistants