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Trial · Interventional

CompletedPhase 3Results postedRegistry data

Effect on Weight Loss of Exenatide Versus Placebo

NCTNCT00375492 (opens ClinicalTrials.gov in a new tab)Other idH8O-US-GWBM
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Overview

Status
Completed
Phase
Phase 3
Enrollment
196 participants (actual)
Sponsor
AstraZeneca · Industry
Design
Randomized · Double masking
Countries
1 country

United States

Start
Sept 2006
Primary completion
Feb 2008
Completion
Feb 2008
First posted
13 Sept 2006 (estimated)
Last update posted
7 Apr 2015 (estimated)
Conditions
Type 2 Diabetes Mellitus

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2006200720082009
  1. Ph 3

    Effect on Weight Loss of Exenatide Versus Placebo

    NCT00375492

    Sept 2006 to Feb 2008

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This trial is designed to compare the effects of twice-daily exenatide and twice-daily placebo on weight loss. This trial will evaluate overweight and obese subjects with type 2 diabetes who have inadequate glycemic control with metformin, sulfonylurea, or metformin plus a sulfonylurea. Subjects will be treated with exenatide or placebo in addition to their current oral antidiabetes agent regimen and participate in a lifestyle modification program.

Interventions

  • exenatideDrug
  • placeboDrug

Arms2

  • Experimental

    Group A

  • Placebo comparator

    Group B

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change From Baseline in Body Weight

    Time frame · Baseline, Week 24

    Registry description

    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 outcomes(11)

  1. Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24

    Time frame · baseline, Week 24

    Registry description

    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.

  2. Change From Baseline in 6-point Self Monitored Blood Glucose (SMBG) Profile at Week 24

    Time frame · baseline, Week 24

    Registry description

    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).

  3. Change From Baseline in Waist Circumference at Week 24

    Time frame · baseline, Week 24

    Registry description

    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).

  4. Ratio of Homeostatic Model Assessment-Beta Cell (HOMA-B) at Week 24 to HOMA-B at Baseline

    Time frame · baseline, Week 24

    Registry description

    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.

  5. Ratio of Homeostatic Model Assessment-Insulin Sensitivity (HOMA-S) at Week 24 to HOMA-S at Baseline

    Time frame · baseline, Week 24

    Registry description

    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.

  6. Change From Baseline in High Density Lipoprotein (HDL) Cholesterol at Week 24

    Time frame · baseline, Week 24

    Registry description

    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.

  7. Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol at Week 24

    Time frame · baseline, Week 24

    Registry description

    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

  8. Change From Baseline in Total Cholesterol at Week 24

    Time frame · baseline, week 24

    Registry description

    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.

  9. Ratio of Triglycerides at Week 24 to Triglycerides at Baseline

    Time frame · baseline, Week 24

    Registry description

    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.

  10. Number of Participants With Hypoglycemic Events During the Study

    Time frame · Baseline to 24 weeks

    Registry description

    Number of participants experiencing one or more events of hypoglycemia at any point in the study

  11. Rate of Hypoglycemic Events

    Time frame · 24 weeks

    Registry description

    Overall rate of hypoglycemia, adjusted for 1 year (ie., events of hypoglycemia per participant per year).

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeLeast squares mean· Baseline, Week 24

Change From Baseline in Body Weight

GroupValue (kg)Spread
Group A (Exenatide)-6.160.54
Group B (Placebo)-3.970.52
Secondary and other outcome results(7)
Secondary outcomeLeast squares mean· baseline, Week 24

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24

GroupValue (percent hemoglobin)Spread
Group A (Exenatide)-1.210.09
Group B (Placebo)-0.730.09
Secondary outcomeLeast squares mean· baseline, Week 24

Change From Baseline in 6-point Self Monitored Blood Glucose (SMBG) Profile at Week 24

GroupValue (mmol/L)Spread
Group A (Exenatide)-1.870.17
Group B (Placebo)-1.200.17
Secondary outcomeLeast squares mean· baseline, Week 24

Change From Baseline in Waist Circumference at Week 24

GroupValue (cm)Spread
Group A (Exenatide)-5.330.71
Group B (Placebo)-4.180.73
Secondary outcomeGeometric mean· baseline, Week 24

Ratio of Homeostatic Model Assessment-Beta Cell (HOMA-B) at Week 24 to HOMA-B at Baseline

GroupValue (Ratio)Spread
Group A (Exenatide)1.460.12
Group B (Placebo)1.290.10
Secondary outcomeGeometric mean· baseline, Week 24

Ratio of Homeostatic Model Assessment-Insulin Sensitivity (HOMA-S) at Week 24 to HOMA-S at Baseline

GroupValue (Ratio)Spread
Group A (Exenatide)1.080.07
Group B (Placebo)0.970.06
Secondary outcomeLeast squares mean· baseline, Week 24

Change From Baseline in High Density Lipoprotein (HDL) Cholesterol at Week 24

GroupValue (mmol/L)Spread
Group A (Exenatide)0.020.02
Group B (Placebo)0.020.02
Secondary outcomeLeast squares mean· baseline, Week 24

Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol at Week 24

GroupValue (mmol/L)Spread
Group A (Exenatide)-0.060.08
Group B (Placebo)-0.040.07

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Group A (Exenatide)exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks–2 / ?87 / ?
Group B (Placebo)placebo (volume equivalent to exenatide injection) twice daily for 24 weeks–2 / ?82 / ?

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

PubMed tag: none · 2012

11 results

Exenatide twice daily: analysis of effectiveness and safety data stratified by age, sex, race, duration of diabetes, and body mass index.

Pencek et al. 2012Postgraduate medicinecited by 45

PMID 22913891DOI 10.3810/pgm.2012.07.2567PUB-22913891

Full text at the publisher11 results
Publisher pageSee results (11)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Diagnosed with type 2 diabetes for at least 6 months * Have been treated with a stable dose of the following for at least 6 weeks prior to screening: \*immediate or extended release metformin, or \*a sulfonylurea, or \*a fixed-dose sulfonylurea/metformin combination therapy * Have an HbA1c of 6.6% to 10.0%, inclusive * Have a Body Mass Index (BMI) of 25 kg/m\^2 to 39.9 kg/m\^2, inclusive Exclusion Criteria: * Are treated with any of the following excluded medications: \*exogenous insulin, thiazolidinedione, or alpha-glucosidase inhibitor for more than 1 week within 6 weeks of screening; \*Symlin injection at any time; \* Byetta injection within 3 months of screening or discontinuation of therapy at any time due to adverse reaction; \*drugs that directly affect gastrointestinal motility; \*use of a weight loss drug (including those available over the counter) within 3 months of screening; \*chronic (lasting longer than 2 weeks) systemic corticosteroids (excluding topical, intranasal, and inhaled preparations) by oral, intravenous, or intramuscular route within 2 months of screening * Have conditions contraindicating metformin and/or sulfonylurea use * Have had a change in lipid-lowering agents within 6 weeks of screening * Have received glucagon-like peptide-1 (GLP-1) analogs, or dipeptidyl peptidase-IV inhibitors (DPP-IV inhibitors) or have previously participated in this study * Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry

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