Sitagliptin Versus Sulphonylurea in Type 2 Diabetes During Ramadan

January 11, 2010 updated by: University of Manchester

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Manchester, United Kingdom, M13 9NT
        • Wellcome Trust Clinical Research Facility

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Sitagliptin 100mg
Drug: Sitagliptin
tablet, 100mg, once daily, 4 weeks
Active Comparator: 2
Sulphonylurea
Drug: sulphonylurea
sulphonylurea, variable, od or bd, during ramadan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Occurrence of hypoglycemia
Time Frame: 4 weeks during Ramadan
4 weeks during Ramadan

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Manchester

Investigators

  • Principal Investigator: Rayaz A Malik, MBChB, PhD, University of Manchester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

October 3, 2008

First Submitted That Met QC Criteria

October 3, 2008

First Posted (Estimate)

October 6, 2008

Study Record Updates

Last Update Posted (Estimate)

January 12, 2010

Last Update Submitted That Met QC Criteria

January 11, 2010

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08/H1005/46

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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