Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Imeglimin: 1000mg twice daily orally, Metformin (equal or more than) 1000mg oral, Glimepiride up to 2mg oral daily for 12months.
Control Intervention1: Vildagliptin: 50mg twice orally,
Sponsors
Dr Noor Husain
Eligibility
Inclusion criteria
Inclusion criteria: 1) Diabetes mellitus with HbA1c between 7.5% to 9%, patients already on Metformin more than 100mg daily along with Glimepiride 1 to 2 mg daily.
Exclusion criteria
Exclusion criteria: 1) Type 1 Diabetes mellitus, cardiovascular disease, renal failure,abnormal liver function test or hepatic disease. 2) more than 2 hypoglycemic drugs, within 12 weeks has received Imeglimin or Vildagliptin 3) Diabetic retinopathy, pancreatitis 4) Pregnant and lactating women, known contraindication, hypersensitivity or allergies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in HbA1cTimepoint: Every 3 months till 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion achieving HbA1c less than 7%, change in Blood glucose fasting and post prandial, Change in BMI.Timepoint: 52 weeks;Safety outcome, symptomatic hypoglycemia or blood glucose less than 50mg/dl, different adverse drug reactions.Timepoint: Any time up to 52 weeks | — |
Countries
India
Contacts
Public ContactDr Noor Husain
Indira Gandhi Institute of Medical Sciences
Outcome results
None listed