NCT00766441

Sitagliptin Versus Sulphonylurea in Type 2 Diabetes During Ramadan

Sitagliptin Versus Sulphonylurea Based Treatments in Muslim Patients With Type 2 Diabetes During Ramadan

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: University of Manchester · Academic / Other
• Sex: All
• Age: 18 Years – 78 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes
• Hypoglycemia

Interventions

Type	Name	Description
DRUG	Sitagliptin	tablet, 100mg, once daily, 4 weeks
DRUG	sulphonylurea	sulphonylurea, variable, od or bd, during ramadan

Timeline

• Start date: 2008-08-01
• Primary completion: 2009-10-01
• Completion: 2009-10-01
• First posted: 2008-10-06
• Last updated: 2010-01-12

Locations

1 site across 1 country: United Kingdom