Efficacy and Safety of Metreleptin Therapy in Patients With Type 1 Diabetes: A Pilot Study
Abstract
OBJECTIVE To study the efficacy and safety of metreleptin therapy in patients with suboptimally controlled type 1 diabetes mellitus (T1DM).
RESEARCH DESIGN AND METHODS After a baseline period of 4 weeks, five female and three male patients with T1DM (mean age 33 years, BMI 23.8 kg/m2) received metreleptin (0.08 mg/kg/day in females and 0.04 mg/kg/day in males) subcutaneously twice daily for 20 weeks followed by an off-therapy period of 4 weeks.
RESULTS Metreleptin therapy did not lower HbA1c significantly compared with the baseline value (mean difference −0.19% [−2.0 mmol/mol] and −0.04% [−0.5 mmol/mol] at 12 and 20 weeks, respectively). Mean body weight reduced significantly by 2.6 and 4.7 kg (P = 0.003) and daily insulin dose by 12.6% and 15.0% at week 12 and 20 (P = 0.006), respectively.
CONCLUSIONS Metreleptin is safe but may not be efficacious in improving glycemic control in patients with T1DM, although it reduces body weight and daily insulin dose modestly.
Footnotes
Clinical trial reg. no. NCT01268644, clinicaltrials.gov.
This article contains Supplementary Data online at http://care.diabetesjournals.org/lookup/suppl/doi:10.2337/dc16-1553/-/DC1.
G.O.C. is currently affiliated with Chicago Diabetes Experts, S.C., Buffalo Grove, IL.
- Received July 18, 2016.
- Accepted January 28, 2017.
- © 2017 by the American Diabetes Association.
Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. More information is available at http://www.diabetesjournals.org/content/license.
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