Addition Of Januvia (Sitagliptin) Improves Glycemic Control In Patients Inadequately Controlled By Metformin (MK0431-078)(COMPLETED)
This study has been completed.
Sponsor:
Merck
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00545584
First received: October 16, 2007
Last updated: April 19, 2011
Last verified: April 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Non-Insulin-Dependent |
Drug: sitagliptin phosphate Behavioral: Comparator: Diet Behavioral: Comparator: Physical Activity |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Merck:
Primary Outcome Measures:
- Hemoglobin A1c Measurement [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]Hemoglobin A1c (HbA1c) is a measure of glycated hemoglobin in the blood. HbA1c greater than 6.5% was considered inadequately controlled.
Secondary Outcome Measures:
- Fasting Plasma Glucose (FPG) Measurement [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]Generally FPG values of ~5.0-7.2 mmol/L would be considered goal (American Diabetes Association).
| Enrollment: | 1512 |
| Study Start Date: | April 2007 |
| Study Completion Date: | November 2009 |
| Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: 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. |
Drug: sitagliptin phosphate
sitagliptin 100 mg once daily. Duration of treatment: 26 Weeks
|
|
Experimental: 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 |
Drug: sitagliptin phosphate
sitagliptin 100 mg once daily. Duration of treatment: 26 Weeks
Behavioral: Comparator: Diet
Diet
|
|
Experimental: 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. |
Drug: sitagliptin phosphate
sitagliptin 100 mg once daily. Duration of treatment: 26 Weeks
Behavioral: Comparator: Diet
Diet
Behavioral: Comparator: Physical Activity
Physical Activity
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp. |
| ClinicalTrials.gov Identifier: | NCT00545584 History of Changes |
| Other Study ID Numbers: | MK-0431-078, 2007_023 |
| Study First Received: | October 16, 2007 |
| Results First Received: | April 19, 2011 |
| Last Updated: | April 19, 2011 |
| Health Authority: | France: Ministry of Health |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Sitagliptin Metformin |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions Dipeptidyl-Peptidase IV Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on October 17, 2012
