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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

870 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-22

Study Completion Date

2011-09-21

Brief Summary

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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.

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Detailed Description

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This study and NCT01131182 (MK-0431-263) 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

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 100mg taken orally once daily with or without metformin

Group Type EXPERIMENTAL

Sitagliptin

Intervention Type DRUG

One 100 mg tablet taken orally once daily

Metformin

Intervention Type DRUG

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.

Sulfonylurea Therapy

Usual sulfonylurea therapy with or without metformin

Group Type ACTIVE_COMPARATOR

Sulfonylurea

Intervention Type DRUG

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

Metformin

Intervention Type DRUG

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.

Interventions

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Sitagliptin

One 100 mg tablet taken orally once daily

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Sitagliptin phosphate, MK-0431, JANUVIA® Amaryl (glimepiride) Glucophage

Eligibility Criteria

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Inclusion Criteria

* Muslim, with type 2 diabetes mellitus
* Intends to fast during the month of Ramadan
* Hemoglobin A1c (HbA1c) ≤10% at screening
* On a stable dose of a SU drug (glibenclamide, glimepiride, or gliclazide), for at least three months, with or without metformin therapy at a stable dose

Exclusion Criteria

* Type 1 diabetes mellitus
* Pregnant or breast feeding or with gestational diabetes
* Hypersensitivity or contraindication to dipeptidyl peptidase-4 (DPP-4) treatment
* Serum creatinine ≥1.5 mg/dL (males), ≥1.4 mg/dL (females)
* History of severe hypoglycemia (defined as a hypoglycemic event requiring the assistance of another individual, and/or resulting in a emergency department admission, physician office visit and/or hospitalization)
* Any use of insulin (prior to or during Ramadan)
* Use of any class of oral antidiabetic therapy other than an SU or metformin
* Current participation in another interventional study

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No