Comparison of Two Treatment Regimens (Sitagliptin Versus Liraglutide) on Participants Who Failed to Achieve Good Glucose Control on Metformin Alone (MK-0431-403)
Overview[ - collapse ][ - ]
| Purpose | This study is being done to compare the effectiveness and safety of two treatment paradigms (oral sitagliptin with or without glimepiride versus liraglutide with or without increased dosing) for the treatment of participants with Type 2 Diabetes that is not adequately controlled with metformin alone. The primary hypothesis postulated that the mean change from baseline in hemoglobin A1c (A1C) in participants treated with a sitagliptin-based treatment is non-inferior to that of participants treated with a liraglutide-based treatment. |
|---|---|
| Condition | Diabetes Mellitus, Type 2 |
| Intervention | Drug: sitagliptin Drug: liraglutide Drug: glimepiride Drug: metformin |
| Phase | Phase 3 |
| Sponsor | Merck Sharp & Dohme Corp. |
| Responsible Party | Merck Sharp & Dohme Corp. |
| ClinicalTrials.gov Identifier | NCT01296412 |
| First Received | February 14, 2011 |
| Last Updated | January 30, 2014 |
| Last verified | January 2014 |
Tracking Information[ + expand ][ + ]
| First Received Date | February 14, 2011 |
|---|---|
| Last Updated Date | January 30, 2014 |
| Start Date | March 2011 |
| Estimated Primary Completion Date | February 2012 |
| Current Primary Outcome Measures | Change From Baseline in Hemoglobin A1c (A1C) [Time Frame: Baseline and Week 26] [Designated as safety issue: No]A1C is measured as percent. Thus, this change from baseline reflects the Week 26 A1C percent minus the Week 0 A1C percent. |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | Comparison of Two Treatment Regimens (Sitagliptin Versus Liraglutide) on Participants Who Failed to Achieve Good Glucose Control on Metformin Alone (MK-0431-403) |
|---|---|
| Official Title | A Phase III, Multicenter, Randomized, Open-label Clinical Trial Comparing the Efficacy and Safety of a Sitagliptin-Based Treatment Paradigm to a Liraglutide-Based Treatment Paradigm in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Monotherapy |
| Brief Summary | This study is being done to compare the effectiveness and safety of two treatment paradigms (oral sitagliptin with or without glimepiride versus liraglutide with or without increased dosing) for the treatment of participants with Type 2 Diabetes that is not adequately controlled with metformin alone. The primary hypothesis postulated that the mean change from baseline in hemoglobin A1c (A1C) in participants treated with a sitagliptin-based treatment is non-inferior to that of participants treated with a liraglutide-based treatment. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 3 |
| Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Diabetes Mellitus, Type 2 |
| Intervention | Drug: sitagliptin 100 mg tablet, orally, once daily. Other Names: MK-0431, Januvia®, Tesavel®, Xelevia®, Ristaben®Drug: liraglutide 0.6 mg by subcutaneous (pen) injection, once daily, on Days 1-7; up-titrated on Day 8 to 1.2 mg daily. At Week 12, dose may be increased to 1.8 mg once daily for participants who did not meet protocol-specified glycemic goals. Other Names: Victoza®Drug: glimepiride starting dose of 1 mg tablet (up-titrated as needed), once daily, as needed, after Week 12. Other Names: Amaryl®Drug: metformin metformin tablets at a dose of ≥1500 mg per day Other Names: Fortamet®, Glucophage®, Glucophage® XR, Glumetza®, Riomet®, Metgluco®, Glycoran® |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 653 |
| Estimated Completion Date | February 2012 |
| Estimated Primary Completion Date | February 2012 |
| Eligibility Criteria | Inclusion criteria - Type 2 diabetes mellitus. - On stable dose of metformin monotherapy at a dose of at least 1500 mg per day for at least 12 weeks and a hemoglobin A1C ≥7.0% and ≤11.0%. - Capable of using a liraglutide pen device. Exclusion criteria - History of Type 1 Diabetes mellitus. - Use of any oral antihyperglycemic agent (AHA) besides metformin, within the prior 12 weeks of screening. - Cardiovascular disorders within the past 3 months including acute coronary syndrome or new or worsening symptoms of coronary heart disease, coronary artery intervention, stroke, or transient ischemic neurological disorder. - Impaired liver function. - Impaired kidney function. - History of malignancy or clinically important hematological disorder that requires disease-specific treatment (chemotherapy, radiation therapy, surgery) or, in the opinion of the investigator, is likely to recur during the duration of the study. - History of leukemia, lymphoma, aplastic anemia, myeloproliferative or myelodysplastic diseases, thrombocytopenia, or malignant melanoma, regardless of the time since treatment. - Pregnancy or breastfeeding, or intention to become pregnant or donate eggs within the projected duration of the study. - Participation in another study with an investigational drug or device within 12 weeks prior to screening. - History of hypersensitivity or any contraindication to sitagliptin, liraglutide, glimepiride, or metformin based upon the labels of the country of the investigational site. - Participation in a weight loss program and not yet in maintenance phase, or starting of a weight loss medication (such as orlistat or phentermine) within the prior 8 weeks. - Surgery within the prior 4 weeks or major surgery planned during the study. - Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2). - User of recreational or illicit drugs or recent history (within the last year) of drug abuse or increased alcohol consumption. |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Not Provided |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01296412 |
|---|---|
| Other Study ID Numbers | 0431-403 |
| Has Data Monitoring Committee | No |
| Information Provided By | Merck Sharp & Dohme Corp. |
| Study Sponsor | Merck Sharp & Dohme Corp. |
| Collaborators | Not Provided |
| Investigators | Not Provided |
| Verification Date | January 2014 |