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ALPHA Sitagliptin Add on to Metformin (0431-103)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00833027
Recruitment Status : Completed
First Posted : January 30, 2009
Results First Posted : September 21, 2010
Last Update Posted : May 15, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Mellitus Drug: sitagliptin phosphate Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 608 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 1, 2008
Primary Completion Date : October 30, 2009
Study Completion Date : October 30, 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Sitagliptin
Drug: sitagliptin phosphate
Sitagliptin 100 mg/day - tablet for 24 weeks
Other Name: Januvia


Outcome Measures

Primary Outcome Measures :
  1. Change From Baseline in HbA1c at Week 24 [ Time Frame: Baseline and Week 24 ]
    HbA1c is measured as percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent


Secondary Outcome Measures :
  1. Change From Baseline in HbA1c at Week 12 [ Time Frame: Baseline and Week 12 ]
    HbA1c is measured as percent. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the Week 0 HbA1c percent


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00833027


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
More Information

Additional Information:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00833027     History of Changes
Other Study ID Numbers: 0431-103
MK0431-103
2009_527
First Posted: January 30, 2009    Key Record Dates
Results First Posted: September 21, 2010
Last Update Posted: May 15, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php


Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Sitagliptin Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action