NCT01131182

Brief Summary

This study will examine whether the incidence of hypoglycemia in patients fasting for Ramadan is lower when treated with sitagliptin as compared to sulfonylurea treatment.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,147

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2010

Shorter than P25 for phase_4

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 26, 2010

Completed
18 days until next milestone

Study Start

First participant enrolled

June 13, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 4, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 4, 2010

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

January 20, 2012

Completed
Last Updated

September 21, 2022

Status Verified

August 1, 2022

Enrollment Period

5 months

First QC Date

May 25, 2010

Results QC Date

December 15, 2011

Last Update Submit

August 24, 2022

Conditions

Type 2 Diabetes Mellitus (T2DM)

Outcome Measures

Primary Outcomes (1)

  • Proportion of Participants With at Least One Symptomatic Hypoglycemic Event

    Symptomatic hypoglycemic event was determined based on the participant's self-reported symptoms including faintness, headache, confusion, anxiety, sweating, tremor, palpitation, nausea, pallor, dizziness, hunger, and sudden behavioral change.

    30 days: first day of Ramadan (August 11) to last day of Ramadan (September 10)

Secondary Outcomes (1)

  • Proportion of Participants With at Least One Symptomatic or Asymptomatic Hypoglycemic Event

    30 days: first day of Ramadan (August 11) to last day of Ramadan (September 10)

Study Arms (2)

Sitagliptin

EXPERIMENTAL

Sitagliptin 100 mg administered orally daily as monotherapy or in combination with metformin over the Ramadan period.

Drug: Sitagliptin phosphateDrug: Metformin

Sulfonylurea

ACTIVE COMPARATOR

Sulfonylurea administered orally daily as monotherapy or in combination with metformin over the Ramadan period.

Drug: Comparator: SulfonylureaDrug: Metformin

Interventions

Sitagliptin phosphateDRUG

Sitagliptin 100 mg tablet administered orally once daily over the Ramadan period.

Also known as: Januvia
Sitagliptin
Comparator: SulfonylureaDRUG

Sulfonylurea (glibenclamide, glimepiride, or gliclazide) administered orally daily over the Ramadan period as per physician's prescription

Sulfonylurea
MetforminDRUG

Participants could continue pre-study metformin as concomitant therapy during the study.

Also known as: Glucophage
SitagliptinSulfonylurea

Eligibility Criteria

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

You may qualify if:

  • Muslim men and women with type 2 diabetes
  • Participants who intend to fast during the month of Ramadan
  • Participants who have been on a stable dose of sulfonylurea for at least three months

You may not qualify if:

  • Participants with type 1 diabetes mellitus
  • Pregnant or breast feeding women
  • Participants with hypersensitivity or contraindication to dipeptidyl peptidase (DPP-4) treatment
  • Participants on insulin
  • Participants on any class of oral diabetic therapy other than sulfonylurea or metformin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Al Sifri S, Basiounny A, Echtay A, Al Omari M, Harman-Boehm I, Kaddaha G, Al Tayeb K, Mahfouz AS, Al Elq A, Radican L, Ozesen C, Katzeff HL, Musser BJ, Suryawanshi S, Girman CJ, Davies MJ, Engel SS; 2010 Ramadan Study Group. The incidence of hypoglycaemia in Muslim patients with type 2 diabetes treated with sitagliptin or a sulphonylurea during Ramadan: a randomised trial. Int J Clin Pract. 2011 Nov;65(11):1132-40. doi: 10.1111/j.1742-1241.2011.02797.x. Epub 2011 Sep 27.

    PMID: 21951832RESULT

  • Lee SWH, Chen WS, Sellappans R, Md Sharif SB, Metzendorf MI, Lai NM. Interventions for people with type 2 diabetes mellitus fasting during Ramadan. Cochrane Database Syst Rev. 2023 Jul 12;7(7):CD013178. doi: 10.1002/14651858.CD013178.pub2.

    PMID: 37435938DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sitagliptin PhosphateMetformin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrazinesBiguanidesGuanidinesAmidinesOrganic Chemicals

Results Point of Contact

Title
Senior Vice President, Global Clinical Development
Organization
Merck Sharpe & Dohme Corp
ClinicalTrialsDisclosure@merck.com
1-800-672-6372

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2010

First Posted

May 26, 2010

Study Start

June 13, 2010

Primary Completion

November 4, 2010

Study Completion

November 4, 2010

Last Updated

September 21, 2022

Results First Posted

January 20, 2012

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will share

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

More information