Sitagliptin Versus Sulphonylurea in Type 2 Diabetes During Ramadan

Phase 4TerminatedNCT00766441

University of Manchester22 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetes Hypoglycemia

Interventions

SitagliptinDRUG

tablet, 100mg, once daily, 4 weeks

sulphonylureaDRUG

sulphonylurea, variable, od or bd, during ramadan

Eligibility

Sex: ALLMin age: 18 YearsMax age: 78 Years

Medical Language ↔ Plain English

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

Locations (1)

Wellcome Trust Clinical Research Facility

Manchester, United Kingdom

Outcomes

Primary Outcomes

Occurrence of hypoglycemia

Time frame: 4 weeks during Ramadan

Secondary Outcomes

Body weight, fasting blood sugar, HbA1c, triglycerides, total cholesterol, LDL-C, HDL-C. CGMS to define glycaemic excursions

Time frame: 4 weeks during Ramadan

Data from ClinicalTrials.gov

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