Efficacy and Safety assessment of Miglitol and Metformin SR Fixed dose combination (MIGNAR MF) in patients of Type 2 Diabetes mellitus
Phase 4
Completed
- Conditions
- Health Condition 1: null- uncontrolled patients of Diabetes mellitus with history of high carbohydrate intake
- Registration Number
- CTRI/2012/01/002336
- Lead Sponsor
- Glenmark Pharmaceuticals Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 500
Inclusion Criteria
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
Exclusion Criteria
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
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method