NCT00766441

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for phase_4 diabetes

Timeline
Completed

Started Aug 2008

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 6, 2008

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

January 12, 2010

Status Verified

October 1, 2008

Enrollment Period

1.2 years

First QC Date

October 3, 2008

Last Update Submit

January 11, 2010

Conditions

DiabetesHypoglycemia

Keywords

diabeteshypoglycemiaramadanfasting

Outcome Measures

Primary Outcomes (1)

  • Occurrence of hypoglycemia

    4 weeks during Ramadan

Secondary Outcomes (1)

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

    4 weeks during Ramadan

Study Arms (2)

1

ACTIVE COMPARATOR

Sitagliptin 100mg

Drug: Sitagliptin

2

ACTIVE COMPARATOR

Sulphonylurea

Drug: sulphonylurea

Interventions

SitagliptinDRUG

tablet, 100mg, once daily, 4 weeks

1
sulphonylureaDRUG

sulphonylurea, variable, od or bd, during ramadan

2

Eligibility Criteria

Age18 Years - 78 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wellcome Trust Clinical Research Facility

Manchester, M13 9NT, United Kingdom

Location

MeSH Terms

Conditions

Diabetes MellitusHypoglycemiaFasting

Interventions

Sitagliptin PhosphateSulfonylurea Compounds

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesFeeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrazinesUreaAmidesOrganic ChemicalsSulfonesSulfur Compounds

Study Officials

  • Rayaz A Malik, MBChB, PhD

    University of Manchester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 3, 2008

First Posted

October 6, 2008

Study Start

August 1, 2008

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

January 12, 2010

Record last verified: 2008-10

Locations

GB(1)