ACTRN12609000634279招募中2 期
A randomised, placebo-controlled, double-blind trial to assess the safety and glucose-lowering efficacy of VVP808 compared to placebo in participants with Type 2 diabetes.
Verva Pharmaceuticals0 个研究点目标入组 80 人开始时间: 2009年7月29日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 75 Years（—）
- 性别
- All
入选标准
- •Participants with Type 2 diabetes mellitus; HbA1c between 6.5 and 8.5%, inclusive at screening; Body Mass Index (BMI) less than or equal to 40 kg/m2 and a total body weight greater than 50kg);
排除标准
- •Current treatment with any hypoglycaemic drug other than metformin; Any systemic treatment with products, which in the Investigator’s opinion, could interfere with glucose metabolism (eg systemic glucocorticoids) within 3 months prior to randomisation; Subject has a clinically significant, active (during the past 12 months) disease of the gastrointestinal, hepatic (liver function tests, more than 200% upper limit of the reference range, except yGlutamuyl transferase), pulmonary, cardiovascular, neurological, genitourinary, endocrine, or haematological system that, in the opinion of the Investigator, may confound the results of the trial or pose additional risk in administering trial product; Current or past history of acidosis; Current hypokalaemia; hyponatraemia; glomerular filtration rate < 60 mL/minute; or elevated plasma lactate; Adrenal insufficiency; Hypersensitivity to, or persons considered at increase risk of hypersensitivity to, methazolamide or acetazolamide, sulfonamides or sulfonamide derivatives, or any excipients in the formulation. (Cross sensitivity between acetazolamide, sulfonamides and other sulfonamide derivatives is possible); History of urolithiasis; History of narrow-angle glaucoma; 12-lead electrocardiogram (ECG) demonstrating QTc > 450 msec at screening; Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of contraception from at least 14 days prior to the first dose of trial medication until completion of follow-up procedures;
研究者
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