Effect of a Basal/Pre-Meal Insulin Strategy (Detemir/Aspart) on Insulin Secretion and Action in Type 2 Diabetes
Status:
Completed
Trial end date:
2010-02-01
Target enrollment:
Participant gender:
Summary
The optimal insulin therapy in T2DM is controversial and its impact on nonalcoholic fatty
liver disease (NAFLD) has not been systematically studied before, and in particular, never
when using the new insulin formulations detemir (Levemir®) or aspart (Novolog®). This study
is to determine the effect on hepatic steatosis and insulin secretion/action of lowering the
fasting plasma glucose (FPG) to target with once daily basal insulin detemir alone or
combining insulin detemir with premeal insulin aspart in patients with uncontrolled type 2
diabetes mellitus (T2DM).
In the first 3 months the investigators will optimize metabolic control in all patients with
intensive basal (bedtime) detemir insulin aiming at a normal fasting plasma glucose. After
this treatment period, patients will be randomized in the second 3 months in a 2:1 ratio to
insulin detemir or detemir plus aspart. The investigators propose that insulin will improve
day-long glycemic control and A1c, reduce hepatic steatosis (NAFLD) (primary endpoint) and
insulin secretion/sensitivity being well tolerated while causing minimal weight gain and
hypoglycemia (secondary endpoints). The study will allow to assess if there is an additional
benefit of adding pre-meal rapid-acting insulin aspart to basal insulin to these endpoints.
Phase:
Phase 4
Details
Lead Sponsor:
University of Florida
Collaborators:
Novo Nordisk A/S VA Office of Research and Development