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OpenTrials
Completed

NCT Number: NCT00875394

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)

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

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sitagliptin phosphate

Drug

sitagliptin 100 mg Once a day (QD) for 24 weeks

Other names: sitagliptin

Comparator: Metformin

Drug

metformin 850 mg Twice a day (BID) for 24 weeks

Other names: metformin

Comparator: Antidiabetic Standard of Care

Drug

Patient can take any oral antidiabetic drug (other than metformin)

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Apr 3, 2009
Registry last updated
May 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.