CTRI/2009/091/000605已完成2 期
A Randomized, Double blind, Placebo controlled, Phase 2 Clinical Study to evaluate the Efficacy and Safety of TLPL/AY/04/2008 as an Add-on therapy with Oral Hypoglycemic agents (OHA) in Type 2 Diabetic Patients.
Tulip Lab Pvt Ltd0 个研究点目标入组 80 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 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
入排标准
入选标准
- •1. Subjects suffering from type 2 diabetes mellitus for more than one year, and stabilized on mono / polydrug oral anti-diabetic therapy (Sulfonylurea alone or combination of sulfonylurea and Biaguanides) for at least last 3 months.
- •2. Subjects having HbA1C value between 7-10% (both inclusive) at screening.
- •3. Subjects having Fasting Plasma Glucose 126-252 mg/dL (both inclusive) at screening.
- •4. Subjects of male gender or a nonpregnant, nonlactating females, at least six weeks postpartum. A urine pregnancy test is required for all female subjects unless subject has had a hysterectomy, tubal ligation, or is > 2 years postmenopausal.
- •5. Subjects having a body mass index (BMI) of 20 ? 35 kg/m2.
- •6. Subjects willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form.
排除标准
- •1. Subjects on insulin therapy or on oral hypoglycemic agents other than Sulfonylurea and Biaguanides.
- •2. Subjects suffering from type-1 DM or types of Diabetes mellitus other than Type -2.
- •3. Subjects having known hepatic or renal disease.
- •4. Subjects having an active malignancy.
- •5. Subjects giving history of significant cardiovascular event < 12 weeks prior to randomization.
- •6. Subjects having known major complications of Diabetes like Ketoacidosis, Nephropathy, Neuropathy, Retinopathy, and Diabetic wounds.
- •7. Subjects having a chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
- •8. Subjects having active metabolic or gastrointestinal diseases that may interfere with nutrient absorption, metabolism, or excretion, excluding diabetes.
- •9. Use of any other investigational drug within 1 month prior to randomization
- •10. Known hypersensitivity to ingredients used in study drug
- •11. Pregnant and Lactating females.
研究者
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