ALPHA Sitagliptin Add on to Metformin - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00833027

Purpose

Canadian physicians to experience in real life clinical practice the efficacy and tolerability of adding sitagliptin to their patients who have their glycemic levels inadequately controlled while on metformin

Condition	Intervention	Phase
Diabetes Mellitus	Drug: sitagliptin phosphate	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A 24 Week, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Adding Sitagliptin 100 mg Once Daily in Patients With T2DM Who Have Inadequate Glycemic Control on Metformin Therapy

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Sitagliptin Sitagliptin phosphate Metformin

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Absolute percent change in HbA1c levels [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To assess the reduction in HbA1c levels after 12 weeks of co-administration of sitagliptin with metformin in T2DM patients with inadequate glycemic control while on metformin monotherapy [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	1000
Study Start Date:	March 2008
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Sitagliptin	Drug: sitagliptin phosphate Sitagliptin 100 mg/day - tablet for 24 weeks

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient Is Currently On Monotherapy With Metformin For At Least 10 Weeks Prior To Study Entry

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00833027

Locations

Canada, Quebec
Merck Frosst Canada Ltd.	Recruiting
Kirkland, Quebec, Canada, H9H 3L1
Contact: Michel Cimon 514-428-2605

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Additional Information:

MedWatch - FDA maintained medical product safety Information This link exits the ClinicalTrials.gov site

PhRMA Clinical Study Results Database - web-based repository for clinical study results This link exits the ClinicalTrials.gov site

Merck: Patient & Caregiver U.S. Product Web Site This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2009_527, MK0431-103
Study First Received:	January 28, 2009
Last Updated:	August 5, 2009
ClinicalTrials.gov Identifier:	NCT00833027 History of Changes
Health Authority:	Canada: Health Canada

Study placed in the following topic categories:

Dipeptidyl-Peptidase IV Inhibitors
Metabolic Diseases
Metformin
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Protease Inhibitors
Sitagliptin

Additional relevant MeSH terms:

Dipeptidyl-Peptidase IV Inhibitors
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Diabetes Mellitus
Endocrine System Diseases

Enzyme Inhibitors
Glucose Metabolism Disorders
Pharmacologic Actions
Protease Inhibitors
Sitagliptin

ClinicalTrials.gov processed this record on August 28, 2009