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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes Mellitus (T2DM)

Treatments: Drug: Comparator: Sulfonylurea; Drug: Sitagliptin phosphate; Drug: Metformin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01131182

2010_538

0431-263

Details and patient eligibility

About

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.

Full description

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

Enrollment: 1,147 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,147 participants in 2 patient groups

Sitagliptin

Experimental group

Description:

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

Treatment:

Drug: Metformin

Drug: Sitagliptin phosphate

Sulfonylurea

Active Comparator group

Description:

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

Treatment:

Drug: Metformin

Drug: Comparator: Sulfonylurea