Effects of Metreleptin in Type 1 Diabetes Mellitus

Phase 1 Terminated 8 enrolled University of Texas Southwestern Medical Center Amylin Pharmaceuticals, LLC. · collab Juvenile Diabetes Research Foundation · collab

NaSingle-groupOpen-labelTreatment

Summary

This study will add leptin therapy to the current insulin therapy of Type 1 Diabetics with the aim of lowering the total insulin requirements and suppressing the steep fluctuations typically associated with Type 1 Diabetes.

Timeline

Start: 2010-09
Primary completion: 2013-01
Completion: 2014-08

Outcome

Missed primary endpoint

Stopped: “Sponsor request”

registry analysis (superiority test); Leptin Therapy Week 12; p = 0.14; Mixed Models Analysis; note: P value comparing baseline to week 12 NCT01268644 ↗

Publications

Background Vasandani C, Clark GO, Adams-Huet B, Quittner C, Garg A. Efficacy and Safety of Metreleptin Therapy in Patients With Type 1 Diabetes: A Pilot Study. Diabetes Care. 2017 May;40(5):694-697. doi: 10.2337/dc16-1553. Epub 2017 Feb 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Leptin	Protein / enzyme biologic	—	Subcutaneous