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: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cinnagen
• Treatments: Insulin; Insulin, Globin Zinc; Liraglutide; Metformin; Secretagogues

Criteria

Inclusion Criteria:

• Subjects with Type 2 diabetes treated with maximum tolerable dose of two oral glucose-lowering agents (OGLAs; Metformin along with a Sulfonylurea/non-sulfonylurea insulin secretagogues) for ≥ 3 months

• 30-65 years of age

• 7.5 ≤ HbA1c < 10

• Body mass index (BMI) of 25-45 kg / m2

Exclusion Criteria:

• Lack of consent for being in the trial and not complying with 26-weeks follow-up period;

• Hypersensitivity to liraglutide or any component of the formulation (excipients include Disodium phosphate dehydrate, Propylene glycol, Phenol, Water for injection)

• Insulin treatment during the previous 3 months (except short-term treatment for intercurrent illness)

• Impaired liver function (alanine aminotransferase concentrations ≥ 2·5 times upper normal range).

• Impaired renal function (eGFR < 60 mL/min/1.73 m2),

• Uncontrolled hypertension (≥ 160/100 mmHg),

• Malignancy

• Used any drugs apart from OGLAs likely to affect glucose concentrations, including androgens, hyperglycemia-associated agents, hypoglycemia-associated agents, MAO inhibitors, quinolone antibiotics, salicylates (Anti-inflammatory dose).

• Treatment with dipeptidyl peptidase 4 inhibitors (DPP4 inhibitors)

• Treatment with systemic corticosteroids

• History or family history of Medullary Thyroid Carcinoma (MTC)

• Multiple endocrine neoplasia syndrome type 2 (MEN2)

• History of pancreatic cancer and pancreatitis

• History of recent MI, uncontrolled CHF, and unstable Angina

• History or known case of severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy

• Pregnancy

• Previous exposure to exenatide or liraglutide