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A Pilot Study of Effects of Exenatide on Body Weight in Non-Diabetic, Obese Patients

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00500370
First received: July 10, 2007
Last updated: June 6, 2014
Last verified: June 2014

July 10, 2007
June 6, 2014
June 2007
February 2008   (final data collection date for primary outcome measure)
Change in Body Weight [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Change in body weight from baseline after 24 weeks of treatment (i.e., body weight at week 24 minus body weight at week 0)
To compare change in body weight in non-diabetic, obese patients with and without impaired glucose tolerance and/or impaired fasting glucose with twice daily exenatide plus lifestyle modification plan or placebo plus lifestyle modification plan [ Time Frame: 24 weeks ]
Complete list of historical versions of study NCT00500370 on ClinicalTrials.gov Archive Site
  • Change in Body Mass Index (BMI) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Change in BMI from baseline after 24 weeks of treatment (i.e., BMI at week 24 minus BMI at week 0)
  • Change in Waist-to-hip Ratio [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Waist-to-hip ratio at week 24 compared to waist-to-hip ratio at week 0 (i.e., waist-to-hip ratio at week 24 minus waist-to-hip ratio at week 0). Waist-to-hip ratio equals waist circumference at given time point divided by hip circumference at given timepoint.
  • Percentage of Patients Experiencing >=5% Weight Loss [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Percentage of exenatide and placebo treated patients experiencing >=5% weight loss after 24 weeks of treatment (i.e., [weight at week 0 minus weight at week 24] divided by weight at week 0 times 100% >=5%)
  • Change in Total Cholesterol [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Change in total cholesterol from baseline after 24 weeks of treatment (i.e., total cholesterol at week 24 minus total cholesterol at week 0)
  • Change in High Density Lipoprotein (HDL) Cholesterol [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Change in HDL cholesterol from baseline after 24 weeks of treatment (i.e., HDL cholesterol at week 24 minus HDL cholesterol at week 0)
  • Ratio of Endpoint (LOCF) to Baseline for Fasting Triglycerides (Logarithmically Transformed) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Ratio of triglycerides at week 24 compared to triglycerides at week 0 (i.e., triglycerides at week 24 divided by triglycerides at week 0)
  • Change in Low Density Lipoprotein (LDL) Cholesterol [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Change in LDL cholesterol from baseline following 24 weeks of treatment (i.e., LDL cholesterol at week 24 minus LDL cholesterol at week 0)
  • Change in Fasting Serum Glucose [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Change in fasting serum glucose from baseline following 24 weeks of treatment (i.e., fasting serum glucose at week 24 minus fasting serum glucose at week 0)
  • Change in Serum Glucose AUC Levels Following Oral Glucose Tolerance Test (OGTT) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Change in serum glucose AUC following OGTT (week 24 compared to week 0) (i.e., serum glucose AUC at week 24 minus serum glucose AUC at week 0)
  • Ratio of Endpoint (LOCF) to Baseline for Homeostatic Model Assessment-Beta Cell (HOMA-B) (Logarithmically Transformed) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Ratio of HOMA-B at week 24 to HOMA-B at week 0 (i.e., HOMA-B at week 24 divided by HOMA-B at week 0). HOMA-B is a measure of beta cell function.
  • Ratio of Endpoint (LOCF) to Baseline for Homeostatic Model Assessment-Insulin Sensitivity (HOMA-S) (Logarithmically Transformed) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Ratio of HOMA-S at week 24 to HOMA-S at week 0 (i.e., HOMA-S at week 24 divided by HOMA-S at week 0). HOMA-S is a measure of insulin sensitivity.
  • Incidence of Patients That Demonstrate Overt Signs of Diabetes Mellitus Diagnosis [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Number of patients in each treatment group that demonstrate overt signs of diabetes mellitus diagnosis by week 24
  • Incidence of Patients That Demonstrate Normalization of Impaired Fasting Glucose (IFG) and/or Impaired Glucose Tolerance (IGT) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Number of patients in each treatment group that demonstrate normalization of IFG and/or IGT by week 24
  • Change in High Sensitivity C-reactive Protein (hsCRP) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Change in hsCRP levels from baseline following 24 weeks of treatment (i.e., hsCRP at week 24 minus hsCRP at week 0)
  • Change in Glycosylated Hemoglobin (HbA1c) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Change in HbA1c from baseline following 24 weeks of treatment (i.e., HbA1c at week 24 minus HbA1c at week 0)
  • To compare the placebo and exenatide treatment groups on the change in: *Body Mass Index (BMI) *Waist circumference and hip circumference *Proportion of patients experiencing >=5% weight loss *Various pharmacodynamic measurements [ Time Frame: 24 weeks ]
  • *Beta cell function and insulin sensitivity *Proportion of patients that demonstrate overt signs of diabetes diagnosis or normalization of impaired fasting glucose and/or impaired glucose tolerance *Safety and tolerability *Health outcome measures [ Time Frame: 24 weeks ]
Not Provided
Not Provided
 
A Pilot Study of Effects of Exenatide on Body Weight in Non-Diabetic, Obese Patients
A Pilot Study of Effects of Exenatide on Body Weight in Non-Diabetic, Obese Patients

This is a multicenter study designed to compare the effect of exenatide plus a lifestyle modification plan versus placebo plus a lifestyle modification plan on weight loss in non-diabetic, obese subjects.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Obesity
  • Drug: exenatide
    subcutaneous injection (5mcg or 10mcg), twice a day
    Other Name: Byetta
  • Drug: placebo
    subcutaneous injection (equivalent volume to active dose), twice a day
  • Experimental: Group A
    Intervention: Drug: exenatide
  • Placebo Comparator: Group B
    Intervention: Drug: placebo
Rosenstock J, Klaff LJ, Schwartz S, Northrup J, Holcombe JH, Wilhelm K, Trautmann M. Effects of exenatide and lifestyle modification on body weight and glucose tolerance in obese subjects with and without pre-diabetes. Diabetes Care. 2010 Jun;33(6):1173-5. doi: 10.2337/dc09-1203. Epub 2010 Mar 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
163
February 2008
February 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Have a Body Mass Index (BMI) >= 30kg/m^2

Exclusion Criteria:

  • Have ever participated in this study previously, or any other study using exenatide (AC2993/LY2148568) or GLP-1 analogs
  • Have participated in an interventional medical, surgical, or pharmaceutical study (a study in which an experimental, drug, medical, or surgical treatment was given) within 30 days of study start (this criterion includes drugs that have not received regulatory approval for any indication at the time of study entry)
  • Diagnosis of diabetes mellitus (other than gestational diabetes), or previous use of anti-diabetic medications for > 3 months
  • Have had a change in prescribed lipid-lowering or blood pressure agents within 4 weeks of screening
  • Used drugs for weight loss (e.g., Xenical [orlistat], Meridia [sibutramine], Acutrim [phenylpropanolamine], Accomplia [rimonabant], Alli [low-dose orlistat], or other similar over-the-counter weight loss remedies or medications) within 3 months of screening
  • Are actively participating in, or have participated in a formal weight loss program within the last 3 months
  • Have a history of chronic use of drugs that directly affect gastrointestinal motility, including, but not limited to Reglan (metoclopramide) and chronic macrolide antibiotics
  • Have been treated with any anti-diabetic medications within 3 months of screening
  • Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy or have received such therapy within the 4 weeks immediately prior to study start
  • Have had bariatric surgery
  • Have had an organ transplant
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT00500370
H8O-MC-GWBP
No
AstraZeneca
AstraZeneca
Eli Lilly and Company
Study Director: James Malone, MD Eli Lilly and Company
AstraZeneca
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP