Health Condition 1: E11- Type 2 diabetes mellitus
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: • Aged 30 to 65 years • Male and female patients with Type 2 diabetes • Patients with inadequate glucose control on any anti diabetic drugs • Body mass index between 20-35 kg/m2 • Having fasting blood glucose > 126 mg/dL • Post prandial blood glucose > 200 mg/dL • Having no serious physical or biochemical abnormalities other than those generally associated with type 2 diabetes and who are willing to give written informed consent
Exclusion criteria
Exclusion criteria: • Patients having diabetes other than non insulin dependent diabetes mellitus • Having history of hypersensitivity, liver or kidney damage or gastrointestinal disorders, acute infections, diseases of blood or hematopoietic organs • Pregnant or lactating women and patients receiving any concomitant medication, which may have interacted with hypoglycemic action of study drug • Previous participation in a clinical trial in the last 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢ Reduction in plasma glucose levels (fasting and post prandial glucose) â?¢ Reduction in HbA1c level (glycosylated hemoglobin) as compared with baseline Timepoint: 3 months At day 21, 45 and day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Incidence of any related adverse effects â?¢ Vital signs and physical examinations (pulse rate, blood pressure, weight) â?¢ Selected biochemistry and hematology parameters at baseline and after treatment Timepoint: 3 months At baseline and day 90 | — |
Countries
India
Contacts
ICBio Clinical Research Pvt. Ltd.