| Trial ID: | L4340 |
| Source ID: | NCT00701935
|
| Associated Drug: |
Placebo
|
| Title: |
Effect of Exenatide on Abdominal Fat Distribution in Patients With Type 2 Diabetes Pretreated With Metformin
|
| Acronym: |
|
| Status: |
TERMINATED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00701935/results
|
| Conditions: |
Diabetes Mellitus
|
| Interventions: |
DRUG: placebo|DRUG: exenatide
|
| Outcome Measures: |
Primary: Percentage Change in Abdominal Visceral Fat From Baseline to 6 Months, Percentage change in abdominal visceral fat, baseline, 6 months | Secondary: Percentage Change in Total Abdominal Fat From Baseline to 6 Months, Percentage change in total abdominal fat, baseline, 6 months|Percentage Change in Subcutaneous Abdominal Fat From Baseline to 6 Months, Percentage change in subcutaneous abdominal fat, baseline, 6 months|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|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|Change in Fasting Plasma Glucose From Baseline to 6 Months, Change in Fasting plasma glucose, baseline, 6 months|Change in Weight From Baseline to 6 Months, Change in weight, baseline, 6 months|Change in Systolic Blood Pressure From Baseline to 6 Months, Change in Systolic blood pressure, baseline, 6 months|Change in Diastolic Blood Pressure From Baseline to 6 Months, Change in Diastolic blood pressure, baseline, 6 months|Change in Total Cholesterol From Baseline to 6 Months, Change in total cholesterol, baseline, 6 months|Change in Triglycerides From Baseline to 6 Months, Change in triglycerides, baseline, 6 months|Change in High-Density Lipoprotein (HDL) Cholesterol From Baseline to 6 Months, Change in HDL cholesterol, baseline, 6 months|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
|
| Sponsor/Collaborators: |
Sponsor: AstraZeneca | Collaborators: Eli Lilly and Company
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
80
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2008-08
|
| Completion Date: |
2012-01
|
| Results First Posted: |
2013-02-13
|
| Last Update Posted: |
2015-04-10
|
| Locations: |
Research Site, Temple, Arizona, United States|Research Site, Colorado Springs, Colorado, United States|Research Site, Honolulu, Hawaii, United States|Research Site, Bellevue, Nebraska, United States|Research Site, Las Vegas, Nevada, United States|Research Site, Calgary, Alberta, Canada|Research Site, Vancouver, British Columbia, Canada|Research Site, Victoria, British Columbia, Canada|Research Site, Winnipeg, Manitoba, Canada|Research Site, Saint John, New Brunswick, Canada|Research Site, Brampton, Ontario, Canada|Research Site, London, Ontario, Canada|Research Site, Ottawa, Ontario, Canada|Research Site, Toronto, Ontario, Canada|Research Site, Chicoutimi, Quebec, Canada|Research Site, Pointe-Claire, Quebec, Canada|Research Site, Quebec, Canada
|
| URL: |
https://clinicaltrials.gov/show/NCT00701935
|
