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

Phase 3

Completed

• Conditions: Diabetes Mellitus, Non-Insulin-Dependent
• Interventions: Drug: sitagliptin phosphate

• Registration Number: NCT00545584
• Lead Sponsor: Merck Sharp & Dohme LLC

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

Not available

Study Timeline

• Study Start: 2007-04-01
• Study First Submitted: 2007-10-16
• Study First Submitted QC: 2007-10-16
• Study First Posted: 2007-10-17
• Primary Completion: 2009-11-19
• Study Completion: 2009-11-19
• Disposition First Submitted: 2010-11-18
• Disposition First Submitted QC: 2011-02-17
• Disposition First Posted: 2011-03-08
• Results First Submitted: 2011-04-19
• Results First Submitted QC: 2011-04-19
• Results First Posted: 2011-05-11
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-07
• Last Update Posted: 2017-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1512

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%)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sitagliptin with Diet Advice	sitagliptin phosphate	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
Sitagliptin with Diet and Physical Activity Advice	sitagliptin phosphate	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.
Sitagliptin with Standard of Care	sitagliptin phosphate	Subjects received sitagliptin 100 mg once daily for 26 Weeks, and: No specific intervention (standard recommendation) on physical exercise and diet.

Primary Outcome Measures

Name	Time	Method
Hemoglobin A1c Measurement	Baseline and Week 24	Hemoglobin A1c (HbA1c) is a measure of glycated hemoglobin in the blood. HbA1c greater than 6.5% was considered inadequately controlled.

Secondary Outcome Measures

Name	Time	Method
Fasting Plasma Glucose (FPG) Measurement	Baseline and Week 24	Generally FPG values of \~5.0-7.2 mmol/L would be considered goal (American Diabetes Association).