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

NCT ID: NCT00545584

Last Updated: 2017-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1512 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-01
• Study Completion Date: 2009-11-19

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.

Conditions

Diabetes Mellitus, Non-Insulin-Dependent

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sitagliptin with Standard of Care

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

Group Type: EXPERIMENTAL

sitagliptin phosphate

Intervention Type: DRUG

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

Sitagliptin with Diet Advice

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

Group Type: EXPERIMENTAL

sitagliptin phosphate

Intervention Type: DRUG

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

Comparator: Diet

Intervention Type: BEHAVIORAL

Diet

Sitagliptin with Diet and Physical Activity Advice

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.

Group Type: EXPERIMENTAL

sitagliptin phosphate

Intervention Type: DRUG

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

Comparator: Diet

Intervention Type: BEHAVIORAL

Diet

Comparator: Physical Activity

Intervention Type: BEHAVIORAL

Physical Activity

Interventions

sitagliptin phosphate

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

Intervention Type: DRUG

Comparator: Diet

Diet

Intervention Type: BEHAVIORAL

Comparator: Physical Activity

Physical Activity

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

2007_023

Identifier Type: -

Identifier Source: secondary_id

0431-078

Identifier Type: -

Identifier Source: org_study_id