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)

• Status: Completed
• Trial end date: 2008-06-27
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Hypoglycemic Agents; Metformin; Sitagliptin Phosphate

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