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

Phase 4

Completed

• Conditions: Type 2 Diabetes Mellitus (T2DM)
• Interventions: Drug: Sitagliptin phosphate; Drug: Metformin

• Registration Number: NCT01131182
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2010-05-25
• Study First Submitted QC: 2010-05-25
• Study First Posted: 2010-05-26
• Study Start: 2010-06-13
• Primary Completion: 2010-11-04
• Study Completion: 2010-11-04
• Disposition First Submitted: 2011-11-02
• Disposition First Submitted QC: 2011-11-02
• Disposition First Posted: 2011-11-06
• Results First Submitted: 2011-12-15
• Results First Submitted QC: 2011-12-15
• Results First Posted: 2012-01-20
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-24
• Last Update Posted: 2022-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1147

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sitagliptin	Sitagliptin phosphate	Sitagliptin 100 mg administered orally daily as monotherapy or in combination with metformin over the Ramadan period.
Sitagliptin	Metformin	Sitagliptin 100 mg administered orally daily as monotherapy or in combination with metformin over the Ramadan period.
Sulfonylurea	Metformin	Sulfonylurea administered orally daily as monotherapy or in combination with metformin over the Ramadan period.

Primary Outcome Measures

Name	Time	Method
Proportion of Participants With at Least One Symptomatic Hypoglycemic Event	30 days: first day of Ramadan (August 11) to last day of Ramadan (September 10)	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.

Secondary Outcome Measures

Name	Time	Method
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)	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.