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Phase 3 Completed N=68 Randomized Treatment

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)

Diabetes Mellitus, Non-Insulin-Dependent
Source: ClinicalTrials.gov NCT00875394 ↗
Enrolled (actual)
68
Serious AEs
0.0%
Results posted
Apr 2011
Primary outcomePrimary: Change From Baseline in Glycosylated Hemoglobin A1C (A1C) at Week 24

Summary

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

Outcome Measures

OutcomeResultp-value
PRIMARY
Change From Baseline in Glycosylated Hemoglobin A1C (A1C) at Week 24

Eligibility 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00875394). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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