CTRI/2016/06/007029尚未招募3 期
A Randomized, Double Blind, Double Dummy, Active Control, Parallel Group Study of Anagliptin compared to Pioglitazone in patients of Type 2 Diabetes Mellitus with inadequate Glycaemic control despite Metformin Monotherapy. - NA
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 260
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
- •GenderMale and Female
- •Patient is willing to participate in the study and signed the
- •informed consent.
- •Male and female, age at screening: 18 years to 65 years
- •Patient with diagnosis of type 2 diabetes mellitus prior to visit 1
- •Body mass index (BMI) between 23 kg/m2 to 45 kg/m2 (at visit 1
- •Previously treated with metformin monotherapy plus diet
- •modifications and exercise.
- •Inadequately controlled diabetes:
- •i.HbA1c: 7.5% to 9.5%
- •ii.ii. Fasting Plasma Glucose: less than or equal to 200 mg/dL (11.1 mmol/L)
排除标准
- •1. Sex and Reproductive Status
- •a. Women who are pregnant or lactating. or of child bearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period
- •2. Target Disease Status
- •a. Patient with a history of type 1 diabetes, diabetes that is a result of pancreatic injury or secondary forms of diabetes
- •b. Acute metabolic diabetic complications within past 3 months
- •c. Patient with history of 3 episodes of hypoglycemia within past 6 months which were clinically significant requiring hospitalization or third party assistance.
- •3. Medical History and Concurrent Diseases
- •Clinically significant medical condition that, might place the patient at unacceptable risk for participation in this study at visit 1 (screening)
- •4. Physical and Laboratory Test Findings
- •a. Patient with uncontrolled hypertension
- •b. Patient with any laboratory test results that might place the patient at unacceptable risk for participation in this
- •5. Allergies
- •a. Patient with hypersensitivity or has had an anaphylactic reaction(s) to any DPP-4 inhibitor or pioglitazone or any of
- •their component.
- •6. Prohibited Treatment and/or Therapies
- •History of treatment or currently being treated or is expected to require or undergo treatment with any of the treatment excluded medications including insulin, oral antidiabetic drugs, anti-obesity drugs etc.
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