Phase 3
Completed N=68
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
| Outcome | Result | p-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
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.