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Study to Compare Sitagliptin Versus Sulfonylurea Treatment During Ramadan Fasting in Patients With Type 2 Diabetes (MK-0431-262)

NCT01340768 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 870

Last updated 2017-06-05

Study results available
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Summary

This is a study comparing the incidence of hypoglycemia while using sitagliptin treatment versus sulfonylurea (SU) treatment in participants with type 2 diabetes mellitus (T2DM) who regularly take an SU drug, and choose to fast during the month of Ramadan. The primary hypothesis is that during the 30 days of Ramadan fasting, treatment with sitagliptin (with or without metformin) compared to SU treatment (with or without metformin) results in a lower incidence of hypoglycemia in participants with T2DM.

Conditions

Interventions

DRUG

Sitagliptin

One 100 mg tablet taken orally once daily

DRUG

Sulfonylurea

Participant continued pre-study sulfonylurea therapy (dose as prescribed by the physician). Pre-study sulfonylurea therapy consisted of either glibenclamide, glimepiride or gliclazide.

DRUG

Metformin

Participants receiving metformin at enrollment, continued pre-study doses of metformin. If necessary, the physician could either discontinue or adjust the dose of metformin during Ramadan.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-22
Primary Completion
2011-09-21
Completion
2011-09-21

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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 NCT01340768 on ClinicalTrials.gov