Sitagliptin Versus Sulphonylurea in Type 2 Diabetes During Ramadan - Full Text View

Sponsored by:	University of Manchester
Information provided by:	University of Manchester
ClinicalTrials.gov Identifier:	NCT00766441

Purpose

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.

Condition	Intervention	Phase
Diabetes Hypoglycemia	Drug: Sitagliptin Drug: sulphonylurea	Phase IV

MedlinePlus related topics: Diabetes Hypoglycemia

Drug Information available for: Sitagliptin phosphate Sitagliptin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Sitagliptin Versus Sulphonylurea Based Treatments in Muslim Patients With Type 2 Diabetes During Ramadan

Further study details as provided by University of Manchester:

Primary Outcome Measures:

Occurrence of hypoglycemia [ Time Frame: 4 weeks during Ramadan ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Body weight, fasting blood sugar, HbA1c, triglycerides, total cholesterol, LDL-C, HDL-C. CGMS to define glycaemic excursions [ Time Frame: 4 weeks during Ramadan ] [ Designated as safety issue: No ]

Estimated Enrollment:	122
Study Start Date:	August 2008
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Sitagliptin 100mg	Drug: Sitagliptin tablet, 100mg, once daily, 4 weeks
2: Active Comparator Sulphonylurea	Drug: sulphonylurea sulphonylurea, variable, od or bd, during ramadan

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.

Eligibility

Ages Eligible for Study:	18 Years to 78 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00766441

Contacts

Contact: Rayaz A Malik, MBChB, PhD	00441612751196	rayaz.a.malik@man.ac.uk
Contact: Adam Greenstein, MBChB	00441612751194	adam.greenstein@manchester.ac.uk

Locations

United Kingdom
Wellcome Trust Clinical Research Facility	Recruiting
Manchester, United Kingdom, M13 9NT
Contact: Adam Greenstein, MBChB 00441611195 adam.greenstein@manchester.ac.uk
Principal Investigator: Rayaz A Malik, MBChB, PhD
Sub-Investigator: Adam Greenstein, MBChB

Sponsors and Collaborators

University of Manchester

Investigators

Principal Investigator:

Rayaz A Malik, MBChB, PhD

University of Manchester

More Information

Responsible Party:	University of Manchester ( Professor R A Malik )
Study ID Numbers:	08/H1005/46
Study First Received:	October 3, 2008
Last Updated:	October 3, 2008
ClinicalTrials.gov Identifier:	NCT00766441
Health Authority:	United Kingdom: Research Ethics Committee; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University of Manchester:

diabetes
hypoglycemia
ramadan
fasting

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy

Metabolic disorder
Glucose Metabolism Disorders
Hypoglycemia
Sitagliptin

Additional relevant MeSH terms:

Dipeptidyl-Peptidase IV Inhibitors
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009