CTRI/2012/01/002336已完成4 期
Efficacy and Safety assessment of Miglitol and Metformin SR Fixed dose combination (MIGNAR MF) in patients of Type 2 Diabetes mellitus - NI
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •Adults (>=18 yrs) with Type 2 Diabetes mellitus
- •Newly diagnosed T2DM pts with HbA1c levels of 7.6 to 8.4% uncontrolled on diet, exercise
- •Patients willing to give written Informed Consent & willing to come for follow up
排除标准
- •Pregnant and lactating women
- •Serious concomitant gastrointestinal disease, in patients with inflammatory bowel disease,colonic ulceration or partial intestinal obstruction, medication likely to affect intestinal motility
- •History of lactic acidosis
- •Aspartate aminotransferase (AST) and/or alanine -aminotransferase (ALT) 2.5 x ULN or lower
- •Serum creatinine 1.5 x ULN
- •Hypersensitivity to Miglitol or Metformin
研究者
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