Comparing Efficacy and Safety of CinnaGen-liraglutide Versus Victoza® in Patients With Type II Diabetes

What this study is testing ClinicalTrials.gov NCT03421119 ↗

Description as written by the study sponsor.

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.

Treatments tested

• Liraglutide 6 MG/ML Pen Injector also known as CinnaGen-liraglutide, Victoza Drug

  Patients in each arm will receive either CinnaGen-liraglutide or Victoza®. Both products will be provided as pen-injector.

• Metformin also known as Metformin Hydrochloride Drug

  Patients who were receiving metformin with maximum tolerable dose prior to study will continue to receive it during the study.

• Sulfonylurea/non-sulfonylurea insulin secretagogues also known as Sulfonylurea or non-sulfonylurea insulin secretagogues Drug

  Patients who were receiving Sulfonylurea/non-sulfonylurea insulin secretagogues with maximum tolerable dose prior to study will continue to receive it during the study.