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)(COMPLETED)
Overview[ - collapse ][ - ]
| 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 | Diabetes Mellitus, Non-Insulin-Dependent |
| Intervention | Drug: sitagliptin phosphate Drug: Comparator: metformin Drug: Comparator: metformin Drug: Comparator: Antidiabetic Standard of Care |
| Phase | N/A |
| Sponsor | Merck Sharp & Dohme Corp. |
| Responsible Party | Merck Sharp & Dohme Corp. |
| ClinicalTrials.gov Identifier | NCT00875394 |
| First Received | April 1, 2009 |
| Last Updated | August 22, 2013 |
| Last verified | August 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | April 1, 2009 |
|---|---|
| Last Updated Date | August 22, 2013 |
| Start Date | February 2007 |
| Estimated Primary Completion Date | June 2008 |
| Current Primary Outcome Measures | Change From Baseline in Glycosylated Hemoglobin A1C (A1C) at Week 24 [Time Frame: Baseline and 24 weeks] [Designated as safety issue: No]Week 24 A1C minus baseline (Week 0) A1C. The unit for A1C is "percent". Thus, this measure represents a difference of percent values. |
| Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
| Brief Title | 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)(COMPLETED) |
|---|---|
| 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 |
| Brief 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 |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | N/A |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Diabetes Mellitus, Non-Insulin-Dependent |
| Intervention | Drug: sitagliptin phosphate sitagliptin 100 mg Once a day (QD) for 24 weeks Other Names: sitagliptinDrug: Comparator: metformin metformin 850 mg Twice a day (BID) for 24 weeks Other Names: metforminDrug: Comparator: metformin metformin 500 mg Three times a day (TID) to 850 mg Twice a day (BID), for 24 weeks Other Names: metforminDrug: Comparator: Antidiabetic Standard of Care Patient can take any oral antidiabetic drug (other than metformin) |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 68 |
| Estimated Completion Date | June 2008 |
| Estimated Primary Completion Date | June 2008 |
| 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 |
| Gender | Both |
| Ages | 30 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Not Provided |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00875394 |
|---|---|
| Other Study ID Numbers | 0431-189 |
| Has Data Monitoring Committee | No |
| Information Provided By | Merck Sharp & Dohme Corp. |
| Study Sponsor | Merck Sharp & Dohme Corp. |
| Collaborators | Not Provided |
| Investigators | Study Director: Medical Monitor Merck Sharp & Dohme Corp. |
| Verification Date | August 2013 |