Study to Assess the Efficacy and Safety of Sitagliptin Added to the Regimen of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (0431-189)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00875394
First received: April 1, 2009
Last updated: August 22, 2013
Last verified: August 2013
  Purpose

After 24 weeks of treatment, to assess the A1C-lowering efficacy of sitagliptin 100 mg once daily added to the regimen of patients with inadequate glycemic control on metformin monotherapy


Condition Intervention
Diabetes Mellitus, Non-Insulin-Dependent
Drug: sitagliptin phosphate
Drug: Comparator: metformin
Drug: Comparator: Antidiabetic Standard of Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Open-label Study to Assess the Efficacy and Safety of Sitagliptin Added to the Regimen of Patients With T2 DM With Inadequate Glycemic Control on Metformin

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Change From Baseline in Glycosylated Hemoglobin A1C (A1C) at Week 24 [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
    Week 24 A1C minus baseline (Week 0) A1C. The unit for A1C is "percent". Thus, this measure represents a difference of percent values.


Enrollment: 68
Study Start Date: February 2007
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
sitagliptin + metformin
Drug: sitagliptin phosphate
sitagliptin 100 mg Once a day (QD) for 24 weeks
Other Name: sitagliptin
Drug: Comparator: metformin
metformin 850 mg Twice a day (BID) for 24 weeks
Other Name: metformin
Active Comparator: 2
metformin + any other oral antidiabetic drug
Drug: Comparator: metformin
metformin 850 mg Twice a day (BID) for 24 weeks
Other Name: metformin
Drug: Comparator: Antidiabetic Standard of Care
Patient can take any oral antidiabetic drug (other than metformin)
Active Comparator: 3
metformin
Drug: Comparator: metformin
metformin 500 mg Three times a day (TID) to 850 mg Twice a day (BID), for 24 weeks
Other Name: metformin

  Eligibility

Ages Eligible for Study:   30 Years to 78 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient Has Type 2 Diabetes Mellitus
  • Patient Is 30-78 Years Of Age On The Day Of Signing Informed Consent
  • Patient Is Currently On Metformin Therapy (1500 Mg/Day)
  • Patient Is A Male Or A Female Who Is Unlikely To Conceive, As Indicated By At Least One Yes Answer To The Following Questions: A) Patient Is A Male. B) Patient Is A Surgically Sterilized Female. C) Patient Is A Postmenopausal Female 45 Years Of Age With >2 Years Since Last Menses. D) Patient Is A Non-Sterilized Premenopausal Female And Agrees To Use An Adequate Method Of Contraception To Prevent Pregnancy Throughout The Study Starting With Visit 1 And For 14 Days After The Last Dose Of Study Medication
  • Patient Understands The Study Procedures, The Alternative Treatments Available, The Risks Involved In The Study And Voluntarily Agrees To Participate By Giving Written Informed Consent
  • Patient Has An A1c of 6.5 % - 11.0%

Exclusion Criteria:

  • Patient Has A History Of Type 1 Diabetes Mellitus Or History Of Ketoacidosis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00875394

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

Additional Information:
No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00875394     History of Changes
Other Study ID Numbers: 0431-189, 2009_571
Study First Received: April 1, 2009
Results First Received: June 12, 2009
Last Updated: August 22, 2013
Health Authority: Mexico: Ministry of Health

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin
Hypoglycemic Agents
Metformin
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 April 17, 2014