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Sitagliptin Versus Sulphonylurea in Type 2 Diabetes During Ramadan

Primary Purpose

Diabetes, Hypoglycemia

Status
Terminated
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Sitagliptin
sulphonylurea
Sponsored by
University of Manchester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes focused on measuring diabetes, hypoglycemia, ramadan, fasting

Eligibility Criteria

18 Years - 78 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Wellcome Trust Clinical Research Facility

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Sitagliptin 100mg

Sulphonylurea

Outcomes

Primary Outcome Measures

Occurrence of hypoglycemia

Secondary Outcome Measures

Body weight, fasting blood sugar, HbA1c, triglycerides, total cholesterol, LDL-C, HDL-C. CGMS to define glycaemic excursions

Full Information

First Posted
October 3, 2008
Last Updated
January 11, 2010
Sponsor
University of Manchester
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1. Study Identification

Unique Protocol Identification Number
NCT00766441
Brief Title
Sitagliptin Versus Sulphonylurea in Type 2 Diabetes During Ramadan
Official Title
Sitagliptin Versus Sulphonylurea Based Treatments in Muslim Patients With Type 2 Diabetes During Ramadan
Study Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Terminated
Why Stopped
inadequate recruitment
Study Start Date
August 2008 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Manchester

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: Primary end point: Occurrence of hypoglycemia. The patients will record hypoglycaemic episodes in a self-monitoring diary together with blood glucose values. 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). A subgroup will undergo CGMS assessment to define glycaemic excursions during and after fasting.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Hypoglycemia
Keywords
diabetes, hypoglycemia, ramadan, fasting

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Sitagliptin 100mg
Arm Title
2
Arm Type
Active Comparator
Arm Description
Sulphonylurea
Intervention Type
Drug
Intervention Name(s)
Sitagliptin
Intervention Description
tablet, 100mg, once daily, 4 weeks
Intervention Type
Drug
Intervention Name(s)
sulphonylurea
Intervention Description
sulphonylurea, variable, od or bd, during ramadan
Primary Outcome Measure Information:
Title
Occurrence of hypoglycemia
Time Frame
4 weeks during Ramadan
Secondary Outcome Measure Information:
Title
Body weight, fasting blood sugar, HbA1c, triglycerides, total cholesterol, LDL-C, HDL-C. CGMS to define glycaemic excursions
Time Frame
4 weeks during Ramadan

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
78 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Muslim men and women with Type 2 diabetes. Age 18-78 years Intending to fast during the month of Ramadan On oral antihyperglycemic agents (sulphonylurea based/combination therapy) Exclusion Criteria: Patient with hypersensitivity or contraindication to Sitagliptin treatment Patient with CKD (creatinine clearance <50 ml/min) Patients who have participated in another intervention study in the last 2 months Patients who do not give informed consent Pregnant or breast feeding women. Patients on insulin Patients with severe liver disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rayaz A Malik, MBChB, PhD
Organizational Affiliation
University of Manchester
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wellcome Trust Clinical Research Facility
City
Manchester
ZIP/Postal Code
M13 9NT
Country
United Kingdom

12. IPD Sharing Statement

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Sitagliptin Versus Sulphonylurea in Type 2 Diabetes During Ramadan

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