Conditions: Diabetes Mellitus, Non-Insulin-Dependent
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1512
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: Subjects received sitagliptin 100 mg once daily for 26 Weeks, and: No specific intervention (standard recommendation) on physical exercise and diet. arm 2: Subjects received sitagliptin 100 mg once daily for 26 Weeks,

and:

Intervention on diet which includes advice on diet with a leaflet and a diary arm 3: Subjects received sitagliptin 100 mg once daily for 26 Weeks,

and:

Intervention on diet + physical activity which includes advice on diet and physical activity with leaflets and diaries PLUS advice on physical activity with the utilization of a pedometer: subjects were asked to walk 10,000 steps per day 5 or more days per week.

Interventions: intervention 1: sitagliptin phosphate intervention 2: Comparator: Diet intervention 3: Comparator: Physical Activity
Intervention descriptions: intervention 1: sitagliptin 100 mg once daily. Duration of treatment: 26 Weeks intervention 2: Diet intervention 3: Physical Activity

Protocol document: