MK0431 and Pioglitazone Co-Administration Factorial Study in Patients With Type 2 Diabetes Mellitus (0431-102 AM2) | RxWiki

MK0431 and Pioglitazone Co-Administration Factorial Study in Patients With Type 2 Diabetes Mellitus (0431-102 AM2)

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Type 2 Diabetes Mellitus
Intervention	Drug: Sitagliptin phosphate Drug: Pioglitazone hydrochloride Drug: Matching placebo to sitagliptin Drug: Matching placebo to pioglitazone Drug: Metformin
Phase	Phase 3
Sponsor	Merck Sharp & Dohme Corp.
Responsible Party	Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier	NCT00722371
First Received	July 22, 2008
Last Updated	March 13, 2014
Last verified	March 2014

Tracking Information[ + expand ][ + ]

First Received Date	July 22, 2008
Last Updated Date	March 13, 2014
Start Date	September 2008
Estimated Primary Completion Date	March 2011
Current Primary Outcome Measures	Change From Baseline in Hemoglobin A1C (A1C) at Week 24 [Time Frame: Baseline and Week 24] [Designated as safety issue: No]A1C represents the percentage of glycosylated hemoglobin. Change From Baseline in A1C at Week 54 [Time Frame: Baseline and Week 54] [Designated as safety issue: No]A1C represents the percentage of glycosylated hemoglobin.
Current Secondary Outcome Measures	Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 [Time Frame: Baseline and Week 24] [Designated as safety issue: No] Change From Baseline in 2-Hour Post-meal Glucose (PMG) at Week 24 [Time Frame: Baseline and Week 24] [Designated as safety issue: No]PMG was measured using the Meal Tolerance Test (MTT). Change From Baseline in FPG at Week 54 [Time Frame: Baseline and Week 54] [Designated as safety issue: No] Change From Baseline in 2-Hour PMG at Week 54 [Time Frame: Baseline and Week 54] [Designated as safety issue: No]PMG was measured using the Meal Tolerance Test (MTT).

Descriptive Information[ + expand ][ + ]

Brief Title	MK0431 and Pioglitazone Co-Administration Factorial Study in Patients With Type 2 Diabetes Mellitus (0431-102 AM2)
Official Title	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
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.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 3
Study Design	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Condition	Type 2 Diabetes Mellitus
Intervention	Drug: Sitagliptin phosphate Sitagliptin 100 mg tablet (blinded) orally once daily for 54 weeks. Other Names: Januvia Tesavel Xelevia Ristaben Drug: Pioglitazone hydrochloride Pioglitazone 15 mg, 30 mg, or 45 mg tablets or capsules (blinded) orally once daily for 54 weeks. Participants randomized to receive pioglitazone 45 mg as monotherapy or in combination with sitagliptin were to start on pioglitazone 30 mg at Week 1 and undergo uptitration to pioglitazone 45 mg at Week 4. Other Names: ActosDrug: Matching placebo to sitagliptin Matching placebo to sitagliptin orally once daily for 54 weeks. Drug: Matching placebo to pioglitazone Matching placebo to pioglitazone tablets or capsules orally once daily for 54 weeks. Drug: Metformin Metformin 500 mg (open-label) was to be initiated as rescue therapy to participants not meeting specific glycemic goals. The dose of metformin may have been uptitrated and adjusted, at the discretion of the investigator, up to the maximum approved dose in the country of origin.
Study Arm (s)	Experimental: Sitagliptin 100 mg Experimental: Pioglitazone 15 mg Experimental: Pioglitazone 30 mg Experimental: Pioglitazone 45 mg Experimental: Sitagliptin 100 mg/ Pioglitazone 15 mg Experimental: Sitagliptin 100 mg/ Pioglitazone 30 mg Experimental: Sitagliptin 100 mg/ Pioglitazone 45 mg

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	1615
Estimated Completion Date	March 2011
Estimated Primary Completion Date	October 2010
Eligibility Criteria	Inclusion Criteria: - Patient is highly unlikely to conceive - Patient meets one of the 3 categories is naïve to all antihyperglycemic agent (AHA) therapies, or is non-naïve based upon the patient's current diet, medical regimen and screening A1c patient is currently not on AHA with a screening A1c >=7.5 % and =<11.0 % patient is currently on either metformin pr sulfonylurea monotherapy with a screening A1c >=7.0 % and =<9.0 % Exclusion Criteria - Patient has a history of type 1 diabetes mellitus or history of ketoacidosis or has C=peptide value of =<0.8 ng/mL - Patient has previously been treated with insulin, thiazolidinedione (TZD) (rosiglitazone or pioglitazone), any Dipeptidyl peptidase-4 (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 - Patient has received treatment with an investigational product within 12 weeks prior to Visit 1
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Not Provided

Administrative Information[ + expand ][ + ]

NCT Number	NCT00722371
Other Study ID Numbers	0431-102
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	March 2014