Sitagliptin Versus Sulphonylurea in Type 2 Diabetes During Ramadan

University of Manchester

Status and phase: Terminated; Phase 4

Conditions: Hypoglycemia; Diabetes

Treatments: Drug: sulphonylurea; Drug: Sitagliptin

Study type: Interventional

Funder types: Other

Identifiers

NCT00766441

08/H1005/46

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 18 to 78 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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22 participants in 2 patient groups

1

Active Comparator group

Description:

Sitagliptin 100mg

Treatment:

Drug: Sitagliptin

2

Active Comparator group

Description:

Sulphonylurea

Treatment:

Drug: sulphonylurea