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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Non-Insulin-Dependent

Treatments: Drug: sitagliptin phosphate; Behavioral: Comparator: Diet; Behavioral: Comparator: Physical Activity

Study type: Interventional

Funder types: Industry

Identifiers

NCT00545584

2007_023

0431-078

Details and patient eligibility

About

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.

Enrollment: 1,512 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,512 participants in 3 patient groups

Sitagliptin with Standard of Care

Experimental group

Description:

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

Treatment:

Drug: sitagliptin phosphate

Sitagliptin with Diet Advice

Experimental group

Description:

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

Treatment:

Drug: sitagliptin phosphate

Behavioral: Comparator: Diet

Sitagliptin with Diet and Physical Activity Advice

Experimental group

Description:

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.

Treatment:

Drug: sitagliptin phosphate

Behavioral: Comparator: Diet

Behavioral: Comparator: Physical Activity