Status:
UNKNOWN
Comparing Efficacy and Safety of CinnaGen-liraglutide Versus Victoza® in Patients With Type II Diabetes
Lead Sponsor:
Cinnagen
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
30-65 years
Phase:
PHASE3
Brief 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 Typ...
Detailed Description
The purpose of this study is to compare the efficacy and safety of liraglutide produced by CinnaGen company with Novo Nordisk liraglutide (Victoza®) in subjects with type II diabetes. Patients with Ty...
Eligibility Criteria
Inclusion
- 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
- 5 ≤ HbA1c \< 10
- Body mass index (BMI) of 25-45 kg / m2
Exclusion
- 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
Key Trial Info
Start Date :
June 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2019
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT03421119
Start Date
June 20 2019
End Date
December 1 2019
Last Update
February 6 2019
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