drugset / Trial / NCT01207934

Recombinant Human Leptin Therapy Effects on Insulin Action

NCT01207934

RandomizedParallel-groupSingle-blindBasic science

Summary

Leptin therapy improves insulin sensitivity in people with leptin-deficiency but it is not known whether it improves insulin action in persons who are not leptin deficient. The purpose of the present study was to determine whether leptin therapy has effects on insulin action in obese subjects with type 2 diabetes mellitus (T2DM). A randomized, placebo controlled trial was conducted in obese subjects with newly-diagnosed T2DM. Subjects were randomized to treatment with placebo, low-dose, or high-dose leptin. Insulin sensitivity was measured.

Timeline

Start
1998-08
Primary completion
2000-07
Completion
2000-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Leptin Protein / enzyme biologic 30 mg
Subject Leptin Protein / enzyme biologic 80 mg