Recombinant Human Leptin Therapy Effects on Insulin Action

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

Outcome

Missed primary endpoint

registry Placebo vs Low Dose Leptin vs High Dose Leptin; p >0.05; ANOVA NCT01207934 ↗

paper In addition, leptin treatment did not increase insulin-mediated stimulation of glucose disposal compared with placebo. PMID 21411512 ↗

Publications

• Mittendorfer B, Horowitz JF, DePaoli AM, McCamish MA, Patterson BW, Klein S. Recombinant human leptin treatment does not improve insulin action in obese subjects with type 2 diabetes. Diabetes. 2011 May;60(5):1474-7. doi: 10.2337/db10-1302. Epub 2011 Mar 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Leptin	Protein / enzyme biologic	30 mg	—
Subject	Leptin	Protein / enzyme biologic	80 mg	—

Indications