Sitagliptin Versus Sulphonylurea in Type 2 Diabetes During Ramadan

Study Overview
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Brief Summary
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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
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To define metabolic alterations during Ramadan: Primary end point: Occurrence of hypoglycemia. The patients will record hypoglycaemic episodes in a self-monitoring diary together with blood glucose values. 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). A subgroup will undergo CGMS assessment to define glycaemic excursions during and after fasting.

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

Conditions
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Diabetes, Hypoglycemia

Intervention / Treatment
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* Drug: Sitagliptin
* Drug: sulphonylurea


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Muslim men and women with Type 2 diabetes. Age 18-78 years Intending to fast during the month of Ramadan On oral antihyperglycemic agents (sulphonylurea based/combination therapy) Exclusion Criteria: Patient with hypersensitivity or contraindication to Sitagliptin treatment Patient with CKD (creatinine clearance <50 ml/min) Patients who have participated in another intervention study in the last 2 months Patients who do not give informed consent Pregnant or breast feeding women. Patients on insulin Patients with severe liver disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 78 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Sitagliptin 100mg | Drug: Sitagliptin<br>* tablet, 100mg, once daily, 4 weeks<br>|
| Active Comparator: 2<br>Sulphonylurea | Drug: sulphonylurea<br>* sulphonylurea, variable, od or bd, during ramadan<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of hypoglycemia |  | 4 weeks during Ramadan | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight, fasting blood sugar, HbA1c, triglycerides, total cholesterol, LDL-C, HDL-C. CGMS to define glycaemic excursions |  | 4 weeks during Ramadan | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes, hypoglycemia, ramadan, fasting