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

Study Overview
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Brief Summary
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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.

Official Title
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Multicenter, Open, Pragmatic, Randomized Trial Comparing the Efficacy of 3 Different Lifestyle Interventions After Addition of Sitagliptin to Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Therapy

Conditions
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Diabetes Mellitus, Non-Insulin-Dependent

Intervention / Treatment
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* Drug: sitagliptin phosphate
* Behavioral: Comparator: Diet
* Behavioral: Comparator: Physical Activity


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sitagliptin with Standard of Care<br>Subjects received sitagliptin 100 mg once daily for 26 Weeks, and: No specific intervention (standard recommendation) on physical exercise and diet. | Drug: sitagliptin phosphate<br>* sitagliptin 100 mg once daily. Duration of treatment: 26 Weeks<br>|
| Experimental: Sitagliptin with Diet Advice<br>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 | Drug: sitagliptin phosphate<br>* sitagliptin 100 mg once daily. Duration of treatment: 26 Weeks<br>Behavioral: Comparator: Diet<br>* Diet<br>|
| Experimental: Sitagliptin with Diet and Physical Activity Advice<br>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. | Drug: sitagliptin phosphate<br>* sitagliptin 100 mg once daily. Duration of treatment: 26 Weeks<br>Behavioral: Comparator: Diet<br>* Diet<br>Behavioral: Comparator: Physical Activity<br>* Physical Activity<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1c Measurement | Hemoglobin A1c (HbA1c) is a measure of glycated hemoglobin in the blood. HbA1c greater than 6.5% was considered inadequately controlled. | Baseline and Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting Plasma Glucose (FPG) Measurement | Generally FPG values of  5.0-7.2 mmol/L would be considered goal (American Diabetes Association). | Baseline and Week 24 |