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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)

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: April 28, 2017
Last verified: April 2017
  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 Phase
Diabetes Mellitus, Non-Insulin-Dependent Drug: sitagliptin phosphate Drug: Comparator: metformin Drug: Comparator: Antidiabetic Standard of Care Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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 ]
    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
Actual Study Start Date: February 1, 2007
Study Completion Date: June 27, 2008
Primary Completion Date: June 27, 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   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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: April 28, 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
Diabetes Mellitus, Type 2
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

ClinicalTrials.gov processed this record on August 17, 2017