Comparing Efficacy and Safety of CinnaGen-liraglutide Versus Victoza® in Patients With Type II Diabetes
Status:
Unknown status
Trial end date:
2019-12-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to compare the efficacy and safety of liraglutide produced by
CinnaGen company and Novo Nordisk liraglutide (Victoza®) in subjects with type II diabetes.
Patients with Type II diabetes treated with two oral glucose-lowering agents for ≥ 3 months,
aged between 30 to 65 years, HbA1c equal or greater than 7.5 and lower than 10, and BMI
between 25 to 45 were included in this study.
This study is a phase III, randomized, two-armed, parallel, double-blind, active-controlled,
and non-inferiority clinical trial. Patients who enter the trial will be randomly allocated
(1:1 ratio) to receive subcutaneous 1.8 mg daily injections of either Victoza® or
CinnaGen-liraglutide. Doses of liraglutide will be up-titrated from 0.6 mg/day in the first
week to 1.2 mg/day in the second, third and fourth weeks up to 1.8 mg/day from the beginning
of the fifth week. Patients continue to receive 1.8 mg/day liraglutide until the end 26th
week.
The primary objective of this study is to assess non-inferiority of CinnaGen-liraglutide to
reference liraglutide in terms of efficacy in patients with T2D. The secondary objectives of
this study are to further compare the efficacy of CinnaGen-liraglutide to reference
liraglutide and to assess the safety of CinnaGen-liraglutide to reference liraglutide.