Sitagliptin Comparative Study in Patients With Type 2 Diabetes (0431-049)

Merck Sharp & Dohme LLC1,050 enrolled

Overview

A study to evaluate the efficacy and safety of sitagliptin in comparison to a commonly used medication in patients with type 2 diabetes

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,050

Conditions

Type 2 Diabetes Mellitus

Interventions

sitagliptin phosphateDRUG

(1) sitagliptin 100mg tablet once daily (q.d.) for a 24-wk treatment period

Comparator: metformin hydrochlorideDRUG

(4) Metformin 500mg tablets once daily (q.d.) for a 24-wk treatment period.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 78 Years

Medical Language ↔ Plain English

General Inclusion Criteria: * Patient has type 2 diabetes mellitus (T2DM) * Patient is inadequately controlled and not on treatment with insulin or oral antihyperglycemic therapy General Exclusion Criteria: * Patient has a history of type 1 diabetes mellitus or history of ketoacidosis * Patient was on antihyperglycemic therapy (insulin or oral) within the prior 4 months

Outcomes

Primary Outcomes

Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24

HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent.

Time frame: Baseline and 24 weeks

Secondary Outcomes

Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Diarrhea

Time frame: Baseline to Week 24

Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Nausea

Time frame: Baseline to Week 24

Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Abdominal Pain

Time frame: Baseline to Week 24

Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Vomiting

Time frame: Baseline to Week 24

Data from ClinicalTrials.gov

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