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Clinical Trial Summary

This study assessed the safety, pharmacokinetics and efficacy of bimagrumab when administered in overweight and obese patients with type 2 diabetes


Clinical Trial Description

A non-confirmatory, randomized, subject and investigator blinded, placebo controlled, parallel-arm study, investigating a 48-week treatment period with i.v. bimagrumab 10 mg/kg in overweight and obese subjects with type 2 diabetes. Participants were randomized and assigned to one of the following 2 treatment arms in a ratio of 1:1: Arm 1: Bimagrumab 10 mg/kg up to maximum 1200 mg, every 4 weeks (12 doses) until week 44. Arm 2: Placebo, every 4 weeks (12 doses) until week 44. The study consisted of a screening baseline period of 3 weeks, treatment period of 48 weeks and then a follow-up period of 8 weeks. Treatment period visits were scheduled every 4 weeks until week 44. Administration of bimagrumab or placebo was done via an i.v. infusion over 30 minutes followed by flushing for 15 minutes. Subjects were asked to return to the Investigator site for dosing approximately every 4 weeks during the treatment period. During those visits, subjects were evaluated for safety, tolerability, PK and efficacy. The treatment period ended approximately 4 weeks after the last dose administration. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03005288
Study type Interventional
Source Novartis
Contact
Status Completed
Phase Phase 2
Start date February 1, 2017
Completion date May 8, 2019

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