Clinical trial NCT00701935: Effect of Exenatide on Abdominal Fat Distribution in Patients With Type 2 Diabetes Pretreated With Metformin
Official title: Effect of Exenatide on Abdominal Fat Distribution in Patients With Type 2 Diabetes Pretreated With Metformin
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Diabetes Mellitus
Keywords: diabetes mellitus
Amylin
Lilly
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2008-06-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage Change in Abdominal Visceral Fat From Baseline to 6 Months
timeFrame: baseline, 6 months
Secondary outcomes:
measure: Percentage Change in Total Abdominal Fat From Baseline to 6 Months
timeFrame: baseline, 6 months
measure: Percentage Change in Subcutaneous Abdominal Fat From Baseline to 6 Months
timeFrame: baseline, 6 months
measure: Change in HbA1c From Baseline to 6 Months
timeFrame: baseline, 6 months
measure: Percentage of Patients With HbA1c <=7.0% at 6 Months
timeFrame: 6 months
measure: Change in Fasting Plasma Glucose From Baseline to 6 Months
timeFrame: baseline, 6 months
measure: Change in Weight From Baseline to 6 Months
timeFrame: baseline, 6 months
measure: Change in Systolic Blood Pressure From Baseline to 6 Months
timeFrame: baseline, 6 months
measure: Change in Diastolic Blood Pressure From Baseline to 6 Months
timeFrame: baseline, 6 months
measure: Change in Total Cholesterol From Baseline to 6 Months
timeFrame: baseline, 6 months
measure: Change in Triglycerides From Baseline to 6 Months
timeFrame: baseline, 6 months
measure: Change in High-Density Lipoprotein (HDL) Cholesterol From Baseline to 6 Months
timeFrame: baseline, 6 months
measure: Assessment of Event Rate of Treatment- Emergent Hypoglycemic Event
timeFrame: baseline, 6 months
Other outcomes:
Locations:
city: Temple
country: United States
facility: Research Site
state: Arizona
city: Colorado Springs
country: United States
facility: Research Site
state: Colorado
city: Honolulu
country: United States
facility: Research Site
state: Hawaii
city: Bellevue
country: United States
facility: Research Site
state: Nebraska
city: Las Vegas
country: United States
facility: Research Site
state: Nevada
city: Calgary
country: Canada
facility: Research Site
state: Alberta
city: Vancouver
country: Canada
facility: Research Site
state: British Columbia
city: Victoria
country: Canada
facility: Research Site
state: British Columbia
city: Winnipeg
country: Canada
facility: Research Site
state: Manitoba
city: Saint John
country: Canada
facility: Research Site
state: New Brunswick
city: Brampton
country: Canada
facility: Research Site
state: Ontario
city: London
country: Canada
facility: Research Site
state: Ontario
city: Ottawa
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Chicoutimi
country: Canada
facility: Research Site
state: Quebec
city: Pointe-Claire
country: Canada
facility: Research Site
state: Quebec
city: Quebec
country: Canada
facility: Research Site
Study officials:
affiliation: Eli Lilly and Company
name: Chief Medical Officer, MD Eli Lilly and Company
role: STUDY_DIRECTOR
References: