Sulfonylurea Add-on Study in Patients With Type 2 Diabetes Mellitus (0431-035)

Merck Sharp & Dohme LLC441 enrolled

Overview

The purpose of this clinical study is to determine the safety and efficacy of an investigational drug in patients with Type 2 diabetes mellitus.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

441

Conditions

Diabetes Mellitus, Type 2

Interventions

Comparator: SitagliptinDRUG

sitagliptin 10 mg tablet, once daily for 54 weeks

Comparator: PlaceboDRUG

Placebo oral tablet once daily for 24 weeks

Comparator: PioglitazoneDRUG

Pioglitazone 30 mg tablet once daily for 30 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with Type 2 Diabetes Mellitus with inadequate glycemic control Exclusion Criteria: * Patients with Type 1 Diabetes Mellitus

Outcomes

Primary Outcomes

Change From Baseline in A1C at Week 24

Hemoglobin A1C (A1C) is measured as percent. Thus this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.

Time frame: Baseline and 24 Weeks

Secondary Outcomes

Change From Baseline in FPG at Week 24

The change from baseline is the Week 24 Fasting Plasma Glucose (FPG) minus the Week 0 FPG.

Time frame: Baseline and 24 Weeks

Data from ClinicalTrials.gov

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