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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00766441
Other study ID # 08/H1005/46
Secondary ID
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


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
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