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

Phase 3

Recruiting

• Conditions: type 2 diabetes.; Type 2 diabetes mellitus

• Registration Number: IRCT20150303021315N15
• Lead Sponsor: CinnaGen Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 6 October 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Subjects with type 2 diabetes treated for = 3 months with a stable metformin dose of =1500 mg and at least half the maximum dose of a sulfonylurea or non-sulfonylurea insulin secretagogues agent(Half of maximum dose)
18–80years of age
HbA1c equal or greater than 7 and equal or smaller than 10.5
Body mass index (BMI) of 20-45 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 equal to or greater than 2.5 times upper normal range).
Impaired renal function (eGFR smaller than 60 mL/min/1.73 m2)
Uncontrolled hypertension (equal or greater than 160/100 mmHg)
Malignancy
Using 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).
Current use of a dipeptidyl peptidase-4 inhibitor (DPP-4i)
Treatment with systemic corticosteroids within last three months
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 within last 3 months
History or known case of severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy
Pregnancy or breast-feeding
Female who intends to become pregnant during the clinical trial period
Previous exposure to exenatide or liraglutide.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in HbA1c after 26 weeks of treatment. Timepoint: Screening, baseline, week 12, and week 26. Method of measurement: By High-performance liquid chromatography (HPLC).