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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00766441

Enrollment

Registered

2008-10-06

Start date

2008-08-31

Completion date

2009-10-31

Last updated

2010-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Hypoglycemia

Keywords

diabetes, hypoglycemia, ramadan, fasting

Brief 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.

Interventions

DRUGSitagliptin

tablet, 100mg, once daily, 4 weeks

DRUGsulphonylurea

sulphonylurea, variable, od or bd, during ramadan

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 78 Years

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

Design outcomes

Primary

Measure	Time frame
Occurrence of hypoglycemia	4 weeks during Ramadan

Secondary

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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026