| Trial ID: | L2908 |
| Source ID: | NCT01006889
|
| Associated Drug: |
Exenatide
|
| Title: |
Adding Exenatide to Insulin Therapy for Patients With Type 2 Diabetes and Non-Alcoholic Fatty Liver Disease
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01006889/results
|
| Conditions: |
Nonalcoholic Fatty Liver Disease|Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Exenatide
|
| Outcome Measures: |
Primary: Hepatic Steatosis, Hepatic steatosis was assessed non-invasively by MRS., 6 months | Secondary: A1c, Patients with controlled T2DM with bedtime insulin alone (n=5) or bedtime insulin and premeal rapid-acting insulin novolog (n=15) had eventide given twice daily for 6 months (if on premeal insulin it was stopped). The goal is to assess if adding SQ exenatide is effective to maintain optimal glycemic control in this population., 6 months|Change in Anthropometric Variables (Weight)., 6 months|Number of Severe Hypoglycemic (Glucose ≤40 mg/dL) Events., 6 months|Insulin Secretion (Hyperglycemic Clamp), Change in C-peptide levels vs. pretreatment in the first and second phase., 6 months|Percent Change From Baseline in Glucose Infusion (M Value) During Hyperglycemic Clamp, M value represents glucose infusion change, 6 months|Lipid Profiles, Lipoprotein Analysis by NMR (LipoScience)., Change in lipid levels vs. pretreatment., 6 months|Change in Anthropometric Variables (BMI)., 6 months
|
| Sponsor/Collaborators: |
Sponsor: University of Florida | Collaborators: Amylin Pharmaceuticals, LLC.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
24
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2008-01
|
| Completion Date: |
2010-02
|
| Results First Posted: |
2016-07-29
|
| Last Update Posted: |
2016-09-28
|
| Locations: |
The University of Texas H.S.C. at San Antonio and the San Antonio Audie L. Murphy VA Hospital, San Antonio, Texas, 78229-3900, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01006889
|
