Addition Of Januvia (Sitagliptin) Improves Glycemic Control In Patients Inadequately Controlled By Metformin (MK0431-078)

Merck Sharp & Dohme LLC1,512 enrolled

Overview

To compare the efficacy of three strategies of lifestyle changes associated with Januvia (sitagliptin) 100 mg/day in patients with Type 2 Diabetes Mellitus (T2DM) inadequately controlled by metformin (hemoglobin A1c \[HbA1c\] 6.5-9%). A difference between the three strategies of lifestyle changes was expected.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,512

Conditions

Diabetes Mellitus, Non-Insulin-Dependent

Interventions

sitagliptin phosphateDRUG

sitagliptin 100 mg once daily. Duration of treatment: 26 Weeks

Comparator: DietBEHAVIORAL

Diet

Comparator: Physical ActivityBEHAVIORAL

Physical Activity

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Man or woman aged \>/= 18 years,with T2DM and treated with the maximal tolerated dose of metformin, with documented or high likely inadequate control of diabetes (HbA1c 6.5-9%) Exclusion Criteria: * Daily insulin treatment or one insulin dose or more within the last 8 weeks or expected insulin treatment within the next 3 months. * Hypoglycemia unawareness or recurrent major hypoglycemia or history of acidoketosis * Known hypersensitivity or contraindication to metformin

Outcomes

Primary Outcomes

Hemoglobin A1c Measurement

Hemoglobin A1c (HbA1c) is a measure of glycated hemoglobin in the blood. HbA1c greater than 6.5% was considered inadequately controlled.

Time frame: Baseline and Week 24

Secondary Outcomes

Fasting Plasma Glucose (FPG) Measurement

Generally FPG values of \~5.0-7.2 mmol/L would be considered goal (American Diabetes Association).

Time frame: Baseline and Week 24

Data from ClinicalTrials.gov

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