Health Condition 1: null- Uncontrolled Type 2 Diabetes
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients receiving stable doses of sulfonylurea and at least 1000 mg metformin for at least 3 months with HbA1c >=7% Patients with ideal body weight > 60 kg Compliance Patient able to understand and willing to fully comply with study procedures and restrictions. Patients ready to undergo a follow-up period of 24 weeks.
Exclusion criteria
Exclusion criteria: Patients with other than type 2 diabetes (Type 1 diabetes). Patients with a history of any retinopathy of any grade including diabetic retinopathy, evidence of an imminent need for retinal laser therapy, uncorrected visual acuity Patients with history of myalgia, aplastic anemia or agranulocytosis, granulocytopenia, psoriasis, porphyria, rash, scaling, scaling eczema, and G6PD deficiency. Patients with significant cardiovascular illness limiting participation of patient in a clinical trial Patients with abnormal renal function (Serum Cr >1.5 mg/dL, BUN > 20 mg/dL). Patients with abnormal liver function (AST and ALT, total bilirubin or alkaline phosphatase > 2.5 times the upper limit of normal values). Pregnant or lactating women Women of childbearing potential not practicing contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate and compare mean change in glycated hemoglobin (HbA1c) levels at Week 12 from baseline between and within treatment groups.Timepoint: To evaluate and compare mean change in glycated hemoglobin (HbA1c) levels at Week 12 from baseline between and within treatment groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate and compare mean change in HbA1c levels at Week 12 from baseline between and within treatment groups. To compare the percentage of patients achieving HbA1c level of 7.0% between treatmentgroups at the end of Week 12 and Week 24. Change in serum creatinine HOMA Ã? and HOMA IR Timepoint: 3 Months | — |
Countries
India
Contacts
Dept. Of Medicine, Patna Medical College & Hospital