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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1147 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-13

Study Completion Date

2010-11-04

Brief Summary

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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.

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Detailed Description

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

Conditions

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Type 2 Diabetes Mellitus (T2DM)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sitagliptin

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

Group Type EXPERIMENTAL

Sitagliptin phosphate

Intervention Type DRUG

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

Metformin

Intervention Type DRUG

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

Sulfonylurea

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

Group Type ACTIVE_COMPARATOR

Comparator: Sulfonylurea

Intervention Type DRUG

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

Metformin

Intervention Type DRUG

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

Interventions

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Sitagliptin phosphate

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

Intervention Type DRUG

Comparator: Sulfonylurea

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

Intervention Type DRUG

Metformin

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

Intervention Type DRUG

Other Intervention Names

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Januvia Glucophage

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No