IRCT20150303021315N15招募中3 期
A randomized, two-armed, parallel, double-blind, active-controlled, non-inferiority clinical trial to compare efficacy and safety of test-liraglutide (CinnaGen Co., Iran) to innovator liraglutide product (Victoza®, Novo Nordisk, Denmark) in patients with type II diabetes (T2D)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 80 years（—）
- 性别
- All
入选标准
- •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
排除标准
- •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)
- •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.
研究者
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