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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

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.

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

subcutaneous injection (5mcg or 10mcg), twice a day

subcutaneous injection (equivalent volume to active dose), twice a day

Research Site

Change in body weight from baseline after 24 weeks of treatment (i.e., body weight at week 24 minus body weight at week 0)

Age Continuous

Gender, Male/Female

Baseline (Week 0)

Change at Endpoint (Week 24)

Analysis pertains to change at endpoint (Week 24)

Change in body weight

Change in BMI from baseline after 24 weeks of treatment (i.e., BMI at week 24 minus BMI at week 0)

Change in Body Mass Index (BMI)

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.

Change in waist-to-hip ratio

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%)

Intent to Treat population; Last Observation Carried Forward

Percentage of patients experiencing >=5% weight loss

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 total cholesterol

Change in HDL cholesterol from baseline after 24 weeks of treatment (i.e., HDL cholesterol at week 24 minus HDL cholesterol at week 0)

Change in high density lipoprotein (HDL) cholesterol

Ratio of triglycerides at week 24 compared to triglycerides at week 0 (i.e., triglycerides at week 24 divided by triglycerides at week 0)

Ratio of Endpoint (LOCF) to Baseline for Fasting Triglycerides (Logarithmically Transformed)

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 low density lipoprotein (LDL) cholesterol

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 fasting serum glucose

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)

Change in serum glucose AUC levels following oral glucose tolerance test (OGTT)

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-Beta Cell (HOMA-B) (logarithmically transformed)

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.

Ratio of endpoint (LOCF) to baseline for Homeostatic Model Assessment-Insulin Sensitivity (HOMA-S) (logarithmically transformed)

Number of patients in each treatment group that demonstrate overt signs of diabetes mellitus diagnosis by week 24

Incidence of patients that demonstrate overt signs of diabetes mellitus diagnosis

Number of patients in each treatment group that demonstrate normalization of IFG and/or IGT by week 24

Incidence of patients that demonstrate normalization of impaired fasting glucose (IFG) and/or impaired glucose tolerance (IGT)

Change in hsCRP levels from baseline following 24 weeks of treatment (i.e., hsCRP at week 24 minus hsCRP at week 0)

Change in high sensitivity C-reactive protein (hsCRP)

Change in HbA1c from baseline following 24 weeks of treatment (i.e., HbA1c at week 24 minus HbA1c at week 0)

Change in glycosylated hemoglobin (HbA1c)

Overall Study

Prior to randomization, subjects participated in a 1-week, single-blind placebo lead-in period.

Arms	Assigned Interventions
Experimental: Group A	Drug: exenatide subcutaneous injection (5mcg or 10mcg), twice a day Other Name: Byetta
Placebo Comparator: Group B	Drug: placebo subcutaneous injection (equivalent volume to active dose), twice a day

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

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator