Effect of Exenatide on Abdominal Fat Distribution in Patients With Type 2 Diabetes Pretreated With Metformin

Diabetes Mellitus Clinical Trial

Official title:

Effect of Exenatide on Abdominal Fat Distribution in Patients With Type 2 Diabetes Pretreated With Metformin

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00701935
• Other study ID #: H8O-CA-GWCE
• Status: Terminated
• Phase: Phase 2
• First received: June 17, 2008
• Last updated: March 23, 2015
• Start date: August 2008
• Est. completion date: January 2012

Study information

• Verified date: March 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

A multicenter, randomized, double-blind, placebo-controlled trial will assess the effects of twice-daily subcutaneous injection with exenatide versus treatment with matching placebo injection on abdominal visceral fat content.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 80
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Patients between 18 and 85 years of age, inclusive.

• Patients with type 2 diabetes

• Patients have been treated with metformin, at a stable dose for at least 3 months prior to Visit 1

• Patients have HbA1c of 7.0% to 8.9%, inclusive.

• Patients have a body mass index >27 kg/m2 and <40 kg/m2 and meet local CT scan body weight requirements. For South Asian, Japanese, and Chinese patients, a body mass index >=25 kg/m2 is acceptable as the lower limit.

• Patients have a history of stable body weight (not varying by >2 kg in the 3 months prior to Visit 1).

• Medications for the treatment of high blood pressure are stable with respect to treatment regimen for 4 weeks prior to Visit 1.

• Stable regimen of lipid-lowering agents for 6 weeks prior to Visit 1.

Exclusion Criteria:

• Have received treatment in the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.

• Have an active or untreated malignancy, or have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.

• Have a history of renal transplantation, or are currently receiving renal dialysis.

• Have had a clinically significant history of cardiac disease or presence of active cardiac disease within 1 year prior to Visit 1, including myocardial infarction, clinically significant arrhythmia, unstable angina, moderate to severe congestive heart failure, coronary artery bypass surgery, or angioplasty; or is expected to require coronary artery bypass surgery or angioplasty during the course of the study.

• Have known hemoglobinopathy or clinically significant, chronic anemia.

• Known or are likely to become transfusion dependent during the study.

• Have active, symptomatic proliferative retinopathy.

• Are receiving chronic treatment for gastrointestinal disease with a drug directly affecting gastrointestinal motility. (i.e. metoclopramide, cisapride, and chronic use of macrolide antibiotics)

• Have severe gastrointestinal disease, including gastroparesis.

• Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 months immediately prior to Visit 1.

• Have taken exenatide, liraglutide or any other GLP-1 receptor agonist in the past 6 months, either in a clinical study or as commercially available medication. Patients with known allergy to exenatide should be excluded.

• Have used any prescription or over the counter drug to promote weight loss within 3 months prior to Visit 1, or intend to use such a drug during the study. (Examples: Xenical [orlistat], Meridia [sibutramine], Acutrim [phenylpropanolamine], Acomplia [rimonabant]).

• Have participated in a structured weight loss program within 3 months prior to Visit 1, or intend to participate in such a plan during this study.

• Have been treated for longer than 2 weeks with any of the following excluded medications within 3 months prior to Visit 1: Insulin; Thiazolidinediones; Alpha-glucosidase inhibitors; Sulfonylureas; Oral DPP-IV inhibitors; Meglitinides.

• Are taking warfarin, or a coumarol derivative.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Drug:
• placebo
subcutaneous injection, twice a day
• exenatide
subcutaneous injection, twice a day, 10mcg

Locations

Country	Name	City	State
Canada	Research Site	Brampton	Ontario
Canada	Research Site	Calgary	Alberta
Canada	Research Site	Chicoutimi	Quebec
Canada	Research Site	London	Ontario
Canada	Research Site	Ottawa	Ontario
Canada	Research Site	Pointe-Claire	Quebec
Canada	Research Site	Quebec
Canada	Research Site	Saint John	New Brunswick
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Vancouver	British Columbia
Canada	Research Site	Victoria	British Columbia
Canada	Research Site	Winnipeg	Manitoba
United States	Research Site	Bellevue	Nebraska
United States	Research Site	Colorado Springs	Colorado
United States	Research Site	Honolulu	Hawaii
United States	Research Site	Las Vegas	Nevada
United States	Research Site	Temple	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage Change in Abdominal Visceral Fat From Baseline to 6 Months	Percentage change in abdominal visceral fat	baseline, 6 months	No
Secondary	Percentage Change in Total Abdominal Fat From Baseline to 6 Months	Percentage change in total abdominal fat	baseline, 6 months	No
Secondary	Percentage Change in Subcutaneous Abdominal Fat From Baseline to 6 Months	Percentage change in subcutaneous abdominal fat	baseline, 6 months	No
Secondary	Change in HbA1c From Baseline to 6 Months	Change in HbA1c from baseline to 6 months. HbA1c is a measurement of the amount of hemogobin that is glycosylated.	baseline, 6 months	No
Secondary	Percentage of Patients With HbA1c <=7.0% at 6 Months	Percentage of patients with HbA1c values <= 7.0% measured at 6 months. HbA1c is a measurement of the amount of hemogobin that is glycosylated.	6 months	No
Secondary	Change in Fasting Plasma Glucose From Baseline to 6 Months	Change in Fasting plasma glucose	baseline, 6 months	No
Secondary	Change in Weight From Baseline to 6 Months	Change in weight	baseline, 6 months	No
Secondary	Change in Systolic Blood Pressure From Baseline to 6 Months	Change in Systolic blood pressure	baseline, 6 months	Yes
Secondary	Change in Diastolic Blood Pressure From Baseline to 6 Months	Change in Diastolic blood pressure	baseline, 6 months	Yes
Secondary	Change in Total Cholesterol From Baseline to 6 Months	Change in total cholesterol	baseline, 6 months	No
Secondary	Change in Triglycerides From Baseline to 6 Months	Change in triglycerides	baseline, 6 months	No
Secondary	Change in High-Density Lipoprotein (HDL) Cholesterol From Baseline to 6 Months	Change in HDL cholesterol	baseline, 6 months	No
Secondary	Assessment of Event Rate of Treatment- Emergent Hypoglycemic Event	All hypoglycemia episodes defined as major (results in loss of consciousness, seizure or coma resolving after administration of glucagon or glucose OR needing third-party assistance to resolve due to severe impairment in consciousness and associated with glucose concentration < 2.8 mol/L.) or minor (non-major event with symptoms consistent with hypoglycemia and glucose value < 2.8 mmol/L prior to treating) or symptoms of hypoglycemia (does not meet the criteria for a major or minor event).	baseline, 6 months	Yes