Sitagliptin Versus Sulphonylurea in Type 2 Diabetes During Ramadan

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2009-10-31

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.

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Detailed Description

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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

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Diabetes Hypoglycemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Sitagliptin 100mg

Group Type ACTIVE_COMPARATOR

Sitagliptin

Intervention Type DRUG

tablet, 100mg, once daily, 4 weeks

2

Sulphonylurea

Group Type ACTIVE_COMPARATOR

sulphonylurea

Intervention Type DRUG

sulphonylurea, variable, od or bd, during ramadan

Interventions

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Sitagliptin

tablet, 100mg, once daily, 4 weeks

Intervention Type DRUG

sulphonylurea

sulphonylurea, variable, od or bd, during ramadan

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

78 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No