Sitagliptin Versus Sulphonylurea in Type 2 Diabetes During Ramadan

Phase 4

Terminated

• Conditions: Diabetes; Hypoglycemia
• Interventions: Drug: sulphonylurea; Drug: Sitagliptin

• Registration Number: NCT00766441
• Lead Sponsor: University of Manchester

Brief Summary

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.

Detailed Description

To define metabolic alterations during Ramadan:

1. Primary end point: Occurrence of hypoglycemia. The patients will record hypoglycaemic episodes in a self-monitoring diary together with blood glucose values.

2. Secondary endpoints: Body weight, fasting blood sugar (FBS), glycosylated haemoglobin (HbA1c)/Fructosamine, triglycerides (TG), total cholesterol (TC), low-density lipoprotein-cholesterol (LDL-C) and high density lipoprotein-cholesterol (HDL-C).

3. A subgroup will undergo CGMS assessment to define glycaemic excursions during and after fasting.

Study Timeline

• Study Start: 2008-08
• Status Verified: 2008-10
• Study First Submitted: 2008-10-03
• Study First Submitted QC: 2008-10-03
• Study First Posted: 2008-10-06
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Last Update Submitted: 2010-01-11
• Last Update Posted: 2010-01-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	sulphonylurea	Sulphonylurea
1	Sitagliptin	Sitagliptin 100mg

Primary Outcome Measures

Name	Time	Method
Occurrence of hypoglycemia	4 weeks during Ramadan

Secondary Outcome Measures

Name	Time	Method
Body weight, fasting blood sugar, HbA1c, triglycerides, total cholesterol, LDL-C, HDL-C. CGMS to define glycaemic excursions	4 weeks during Ramadan

Trial Locations

Locations (1)

Wellcome Trust Clinical Research Facility; 🇬🇧 Manchester, United Kingdom