Study of Sitagliptin Treatment in Patients With Type 2 Diabetes During Ramadan (0431-263)

An Open-Label, Randomized Naturalistic Study to Evaluate the Incidence of Hypoglycemia Comparing Sitagliptin With Sulfonylurea Treatment in Patients With Type 2 Diabetes During Ramadan Fasting

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus (T2DM)
• Intervention / Treatment: Drug: Sitagliptin phosphate; Drug: Metformin; Drug: Comparator: Sulfonylurea

Detailed Description

This study and NCT01340768 (MK-0431-262) have the same design but are conducted under separate protocols, in different countries, according to local guidelines.

• Study Type: Interventional
• Enrollment (Actual): 1147
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sitagliptin; Sitagliptin 100 mg administered orally daily as monotherapy or in combination with metformin over the Ramadan period.	Drug: Sitagliptin phosphate; Sitagliptin 100 mg tablet administered orally once daily over the Ramadan period.; Other Names: Januvia; Drug: Metformin; Participants could continue pre-study metformin as concomitant therapy during the study.; Other Names: Glucophage
Active Comparator: Sulfonylurea; Sulfonylurea administered orally daily as monotherapy or in combination with metformin over the Ramadan period.	Drug: Metformin; Participants could continue pre-study metformin as concomitant therapy during the study.; Other Names: Glucophage; Drug: Comparator: Sulfonylurea; Sulfonylurea (glibenclamide, glimepiride, or gliclazide) administered orally daily over the Ramadan period as per physician's prescription

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Participants With at Least One Symptomatic or Asymptomatic Hypoglycemic Event	Hypoglycemic event was based on the participant's self-report and/or finger-stick blood glucose level. Symptomatic hypoglycemic symptoms included 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)

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2010
• Primary Completion (Actual): November 4, 2010
• Study Completion (Actual): November 4, 2010

Study Registration Dates

• First Submitted: May 25, 2010
• First Submitted That Met QC Criteria: May 25, 2010
• First Posted (Estimate): May 26, 2010

Study Record Updates

• Last Update Posted (Actual): September 21, 2022
• Last Update Submitted That Met QC Criteria: August 24, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protease Inhibitors; Incretins; Dipeptidyl-Peptidase IV Inhibitors; Metformin; Sitagliptin Phosphate
• Other Study ID Numbers: 0431-263; 2010_538

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf