Adding Exenatide to Insulin Therapy for Patients With Type 2 Diabetes and Non-Alcoholic Fatty Liver Disease
The primary aim of the study is to determine the impact on hepatic steatosis of replacing premeal rapid-acting insulin for exenatide (Byetta) while maintaining bedtime long-acting detemir (Levemir) insulin in well-controlled patients with type 2 diabetes mellitus (T2DM) and nonalcoholic fatty liver disease (NAFLD).
Secondary aims are to learn: 1) the efficacy and safety of such approach and whether it is an acceptable treatment strategy compared to intensified insulin therapy alone; 2) mechanisms of action (effects on insulin secretion and insulin action); 3) its impact on weight (can it prevent insulin-associated weight gain or cause weight loss) and rates of hypoglycemia; 4) if it may improve specific plasma biomarkers of disease activity in NAFLD and inflammatory markers common to both conditions - T2DM and NAFLD (hsCRP, ICAM, VCAM).
Nonalcoholic Fatty Liver Disease
Type 2 Diabetes Mellitus
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A New Treatment Strategy of Adding Exenatide to Insulin Therapy for Patients With Type 2 Diabetes and Non-Alcoholic Fatty Liver Disease (NAFLD)|
- Hepatic Steatosis [ Time Frame: 6 months ] [ Designated as safety issue: No ]Hepatic steatosis was assessed non-invasively by MRS.
- A1c [ Time Frame: 6 months ] [ Designated as safety issue: No ]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.
- Change in Anthropometric Variables (Weight). [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Number of Severe Hypoglycemic (Glucose ≤40 mg/dL) Events. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- Insulin Secretion (Hyperglycemic Clamp) [ Time Frame: 6 months ] [ Designated as safety issue: No ]Change in C-peptide levels vs. pretreatment in the first and second phase.
- Percent Change From Baseline in Glucose Infusion (M Value) During Hyperglycemic Clamp [ Time Frame: 6 months ] [ Designated as safety issue: No ]M value represents glucose infusion change
- Lipid Profiles, Lipoprotein Analysis by NMR (LipoScience). [ Time Frame: 6 months ] [ Designated as safety issue: No ]Change in lipid levels vs. pretreatment.
- Change in Anthropometric Variables (BMI). [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||January 2008|
|Study Completion Date:||February 2010|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
Experimental: Exenatide (twice daily)
Patients with T2DM well-controlled on an intensified insulin regimen for the previous 6 months by the will have their insulin aspart discontinued and replaced for exenatide twice daily while continuing the bedtime detemir insulin. Safety and efficacy parameters will be measured before and after 6 months of treatment.
The participants with T2DM well-controlled on an intensified insulin regimen for the previous 6 months with the combination of a premeal insulin injection of the drug aspart (Novolog) three times a day and a bedtime insulin injection of the drug detemir (Levemir). The dosage of the insulin is determined by the need by the need of the participant. The Exenatide treatment will consist of an injection of the insulin twice daily and will replace the premeal insulin regiment of aspart.
Other Name: Byetta
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01006889
|United States, Texas|
|The University of Texas H.S.C. at San Antonio and the San Antonio Audie L. Murphy VA Hospital|
|San Antonio, Texas, United States, 78229-3900|
|Principal Investigator:||Kenneth Cusi, M.D.||University of Florida|