Health Condition 1: null- uncontrolled patients of Diabetes mellitus with history of high carbohydrate intake
Conditions
Interventions
Intervention1: Mignar MF: Tablet of MIGNAR MF 25 containing Metformin SR 500 mg and Miglitol 25 mg
Tablet MIGNAR MF 50 containing Metformin SR 500 mg and Miglitol 50 mg
1 tablet of MIGNAR MF taken
Sponsors
Glenmark Pharmaceuticals Limited
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Magnitude of FPG and PPG reduction from baseline at end of 6 weeks of treatment Percentage of subjects reaching treatment goals of FPG (110 mg/dl) and PPG (140 mg/dl) at the end of 12 wks Timepoint: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Magnitude of HbA1c reduction from baseline at end of 12 weeks of treatment Percentage of patients developing GI side effects at the end of 12 wks Timepoint: 12 weeks | — |
Countries
India
Contacts
Public ContactDr KKrishnaprasad
Glenmark Pharmaceuticals Ltd
Outcome results
None listed