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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Sulfonylurea; Drug: Metformin; Drug: Sitagliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01340768

CTRI/2011/06/001838 (Registry Identifier)

0431-262

Details and patient eligibility

About

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.

Full description

This study and NCT01131182 (MK-0431-263) have the same design but are conducted under separate protocols, in different countries, according to local guidelines.

Enrollment: 870 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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870 participants in 2 patient groups

Sitagliptin

Experimental group

Description:

Sitagliptin 100mg taken orally once daily with or without metformin

Treatment:

Drug: Sitagliptin

Drug: Metformin

Sulfonylurea Therapy

Active Comparator group

Description:

Usual sulfonylurea therapy with or without metformin

Treatment:

Drug: Metformin

Drug: Sulfonylurea