Adding Exenatide to Insulin Therapy for Patients With Type 2 Diabetes and Non-Alcoholic Fatty Liver Disease
Status:
Completed
Trial end date:
2010-02-01
Target enrollment:
Participant gender:
Summary
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).