Sitagliptin Versus Sulphonylurea in Type 2 Diabetes During Ramadan

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00766441
• Other study ID #: 08/H1005/46
• Status: Terminated
• Phase: Phase 4
• First received: October 3, 2008
• Last updated: January 11, 2010
• Start date: August 2008
• Est. completion date: October 2009

Study information

• Verified date: October 2008
• Source: University of Manchester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics CommitteeUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 78 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Hypoglycemia

Intervention

Drug:
• Sitagliptin
tablet, 100mg, once daily, 4 weeks
• sulphonylurea
sulphonylurea, variable, od or bd, during ramadan

Locations

Country	Name	City	State
United Kingdom	Wellcome Trust Clinical Research Facility	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
University of Manchester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of hypoglycemia		4 weeks during Ramadan	Yes
Secondary	Body weight, fasting blood sugar, HbA1c, triglycerides, total cholesterol, LDL-C, HDL-C. CGMS to define glycaemic excursions		4 weeks during Ramadan	No