Diabetes Clinical Trial
Official title:
Sitagliptin Versus Sulphonylurea Based Treatments in Muslim Patients With Type 2 Diabetes During Ramadan
This study will assess if Sitagliptin addition to metformin or glitazone is better than current sulphonylurea based treatments during Ramadan. The rationale is that Sitagliptin offers metabolic advantages primarily with the low incidence of hypoglycemia over current sulphonylurea based treatments.
Status | Terminated |
Enrollment | 22 |
Est. completion date | October 2009 |
Est. primary completion date | October 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 78 Years |
Eligibility |
Inclusion Criteria: 1. Muslim men and women with Type 2 diabetes. 2. Age 18-78 years 3. Intending to fast during the month of Ramadan 4. On oral antihyperglycemic agents (sulphonylurea based/combination therapy) Exclusion Criteria: 1. Patient with hypersensitivity or contraindication to Sitagliptin treatment 2. Patient with CKD (creatinine clearance <50 ml/min) 3. Patients who have participated in another intervention study in the last 2 months 4. Patients who do not give informed consent 5. Pregnant or breast feeding women. 6. Patients on insulin 7. Patients with severe liver disease |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | Wellcome Trust Clinical Research Facility | Manchester |
Lead Sponsor | Collaborator |
---|---|
University of Manchester |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Occurrence of hypoglycemia | 4 weeks during Ramadan | Yes | |
Secondary | Body weight, fasting blood sugar, HbA1c, triglycerides, total cholesterol, LDL-C, HDL-C. CGMS to define glycaemic excursions | 4 weeks during Ramadan | No |
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