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

NCT01131182 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1147

Last updated 2022-09-21

Study results available
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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.

Conditions

  • Type 2 Diabetes Mellitus (T2DM)

Interventions

DRUG

Sitagliptin phosphate

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

DRUG

Comparator: Sulfonylurea

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

DRUG

Metformin

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

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-13
Primary Completion
2010-11-04
Completion
2010-11-04

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01131182 on ClinicalTrials.gov