MK0431 and Pioglitazone Co-Administration Factorial Study in Patients With Type 2 Diabetes Mellitus
Tracking InformationStart Date ICMJE | September 2008 |
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Estimated Primary Completion Date | September 2010 (final data collection date for primary outcome measure) |
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Current Primary Outcome Measures ICMJE (submitted: October 26, 2009) | Evaluate the change from baseline HbA1c (Hemoglobin A1c) Sitagliptin/Pioglitazone combination compared with Pioglitazone monotherapy & Sitagliptin monotherapy at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ] |
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Original Primary Outcome Measures ICMJE (submitted: July 24, 2008) | Test the safety and efficacy of the co-administration of sitagliptin and pioglitazone compared to sitagliptin monotherapy and pioglitazone monotherapy on HbA1c [ Time Frame: Efficacy at 24 weeks, Safety at 54 weeks ] [ Designated as safety issue: Yes ] |
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Change History | Complete list of historical versions of study NCT00722371 on ClinicalTrials.gov Archive Site |
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Current Secondary Outcome Measures ICMJE (submitted: October 26, 2009) | - Change from Baseline in FPG (Fasting Plasma Glucose) at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
- Change from Baseline in 2-Hour PMG (Post-Meal Glucose) at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
- Change from Baseline in HbA1c (Hemoglobin A1C) at Week 54 [ Time Frame: Week 54 ] [ Designated as safety issue: No ]
- Change from Baseline in FPG (Fasting Plasma Glucose) at Week 54 [ Time Frame: Week 54 ] [ Designated as safety issue: No ]
- Change from Baseline in 2-Hour PMG (Post-Meal Glucose) at Week 54 [ Time Frame: Week 54 ] [ Designated as safety issue: No ]
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Original Secondary Outcome Measures ICMJE (submitted: July 24, 2008) | HbA1c, 2-hour postprandial glucose, and fasting plasma glucose [ Time Frame: 24 and 54 weeks ] [ Designated as safety issue: No ] |
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Descriptive InformationBrief Title ICMJE | MK0431 and Pioglitazone Co-Administration Factorial Study in Patients With Type 2 Diabetes Mellitus |
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Official Title ICMJE | A Multicenter, Randomized, Double-Blind Study of the Co-Administration of Sitagliptin and Pioglitazone in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control |
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Brief Summary | A study to evaluate the efficacy and safety of sitagliptin and pioglitazone co-administration in comparison with sitagliptin and pioglitazone monotherapy in patients with type 2 diabetes |
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Detailed Description | |
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Study Phase | Phase III |
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Study Type ICMJE | Interventional |
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Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
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Condition ICMJE | Type 2 Diabetes Mellitus |
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Intervention ICMJE | - Drug: Comparator: pioglitazone hydrochloride (+) sitagliptin phosphate
Arm 1: sitagliptin 100mg tablets or Pbo + pioglitazone 15mg tablets or capsules or Pbo Arm 2: sitagliptin 100mg tablets + pioglitazone 30mg tablets or capsules or Pbo Arm 3: sitagliptin 100mg tablets + pioglitazone 45mg tablets or capsules or Pbo. Taken once daily for a treatment period of 54 weeks. Other Name: JANUVIA(TM) - Drug: Comparator: pioglitazone hydrochloride
Arm 4: pioglitazone 15mg tablets or capsules or Pbo. Arm 5: pioglitazone 30mg tablets or capsules or Pbo. Arm 6: pioglitazone 45mg tablets or capsules or Pbo. Taken once daily for a treatment period of 54 weeks. - Drug: Comparator: sitagliptin phosphate
sitagliptin 100mg tablets or Pbo taken once daily for a treatment period of 54 weeks. Other Name: JANUVIA (TM)
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Study Arms / Comparison Groups | - 1: Experimental
sitagliptin/Pbo; pioglitazone/Pbo. Intervention: Drug: Comparator: pioglitazone hydrochloride (+) sitagliptin phosphate - 2: Experimental
sitagliptin/Pbo; pioglitazone/Pbo Intervention: Drug: Comparator: pioglitazone hydrochloride (+) sitagliptin phosphate - 3: Experimental
sitagliptin/Pbo; pioglitazone/Pbo Intervention: Drug: Comparator: pioglitazone hydrochloride (+) sitagliptin phosphate - 4: Active Comparator
pioglitazone/Pbo Intervention: Drug: Comparator: pioglitazone hydrochloride - 5: Active Comparator
pioglitazone/Pbo Intervention: Drug: Comparator: pioglitazone hydrochloride - 6: Active Comparator
pioglitazone/Pbo Intervention: Drug: Comparator: pioglitazone hydrochloride - 7: Experimental
sitagliptin/Pbo Intervention: Drug: Comparator: sitagliptin phosphate
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Recruitment InformationEstimated Enrollment ICMJE | 1295 |
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Estimated Completion Date | April 2011 |
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Estimated Primary Completion Date | September 2010 (final data collection date for primary outcome measure) |
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Eligibility Criteria ICMJE | Inclusion Criteria: - Patient is is highly unlikely to conceive
- Patient is naïve to all AHA therapies
- Patient has T2DM.and is >=18 and <= 78 years of age on day of signing informed consent
Exclusion Criteria: - Patient has a history of type 1 diabetes mellitus or history of ketoacidosis
- Patient has previously been treated with insulin, TZD (rosiglitazone or pioglitazone), any DPP-4 inhibitor (sitagliptin, vildagliptin, or alogliptin), exenatide or has previously been in a clinical study with any DPP-4 inhibitor or incretin mimetic
- Patient is on a weight loss program and is not in the maintenance phase or has started a weight loss medication (e.g. orlistat or sibutramine) within the prior 8 weeks
- Patient has undergone surgery within the prior 30 days or has major surgery planned during the study
- Patient has a medical history of active liver disease including chronic active hepatitis B or C or symptomatic gallbladder disease including primary biliary cirrhosis
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Gender | Both |
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Ages | 18 Years to 78 Years |
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Accepts Healthy Volunteers | No |
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Contacts ICMJE | Contact: Toll Free Number | 1-888-577-8839 | | |
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Location Countries ICMJE | United States, Australia, Austria, Chile, Costa Rica, Croatia, Greece, Italy, Mexico, Peru, Philippines, Russian Federation, Saudi Arabia, Serbia, Slovenia, South Africa, Taiwan, Turkey |
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Administrative InformationNCT ID ICMJE | NCT00722371 |
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Responsible Party | Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc. |
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Study ID Numbers ICMJE | 2008_522, MK0431-102 |
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Study Sponsor ICMJE | Merck |
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Collaborators ICMJE | |
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Investigators ICMJE | Study Director: | Medical Monitor | Merck | |
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Information Provided By | Merck |
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