A Study to Evaluate the Safety and Efficacy of Sitagliptin 100 mg in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control (MK-0431-229)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Comparator: placebo to Sitagliptin; Drug: Comparator: pioglitazone; Drug: Metformin; Drug: Sitagliptin phosphate; Drug: Glimepiride or gliclazide; Drug: Pioglitazone rescue therapy; Drug: Comparator: placebo to pioglitazone

Study type: Interventional

Funder types: Industry

Identifiers

NCT01076075

0431-229

2010_513

MK-0431-229 (Other Identifier)

Details and patient eligibility

About

This study will evaluate whether the addition of Sitagliptin treatment provides a greater decrease in A1C levels compared to placebo in participants with inadequate glycemic control on sulfonylurea and metformin combination therapy.

Enrollment: 427 patients

Sex: All

Ages: 18 to 78 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes mellitus
• Hemoglobin A1C of ≥7.5% and ≤10.5%
• Currently taking a stable dose of metformin (at least 1500 mg/day) and either glimepiride (at least 2 mg/day) or gliclazide (at least 50% of maximum registered dose) for at least 10 weeks prior to study start
• Male, or a female who is highly unlikely to conceive

Exclusion criteria

• Type 1 diabetes mellitus or ketoacidosis
• Taking a dipeptidyl peptidase-4 (DPP-4) inhibitor (such as sitagliptin) or a glucagon-like peptide-1 (GLP-1) mimetic (such as exenatide or liraglutide) or required insulin therapy within 12 weeks prior to study start
• On a weight loss program not in the maintenance phase or on a weight loss medication
• History of liver disease, heart failure, heart disease, stroke, high blood pressure, blood disorders, or cancer
• HIV positive
• Pregnant

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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427 participants in 2 patient groups

placebo/pioglitazone

Active Comparator group

Description:

Phase A (Weeks 0-24): placebo to Sitagliptin 100 mg; Phase B (Weeks 24-54): placebo to Sitagliptin 100 mg + pioglitazone 30 mg

Treatment:

Drug: Comparator: placebo to Sitagliptin

Drug: Pioglitazone rescue therapy

Drug: Glimepiride or gliclazide

Drug: Metformin

Drug: Comparator: pioglitazone

Sitagliptin

Experimental group

Description:

Phase A (Weeks 0-24): Sitagliptin 100 mg; Phase B (Weeks 24-54): Sitagliptin 100 mg + placebo to pioglitazone

Treatment:

Drug: Pioglitazone rescue therapy

Drug: Glimepiride or gliclazide

Drug: Comparator: placebo to pioglitazone

Drug: Sitagliptin phosphate

Drug: Metformin