MK0431 and Pioglitazone Co-Administration Factorial Study in Patients With Type 2 Diabetes Mellitus - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00722371

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	Intervention	Phase
Type 2 Diabetes Mellitus	Drug: pioglitazone hydrochloride (+) sitagliptin phosphate Drug: pioglitazone hydrochloride Drug: sitagliptin phosphate	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Pioglitazone Pioglitazone hydrochloride Sitagliptin Sitagliptin phosphate

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

HbA1c, 2-hour postprandial glucose, and fasting plasma glucose [ Time Frame: 24 and 54 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	1295
Study Start Date:	January 2008
Estimated Study Completion Date:	January 2011
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental sitagliptin/Pbo; pioglitazone/Pbo.	Drug: 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.
2: Experimental sitagliptin/Pbo; pioglitazone/Pbo	Drug: 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.
3: Experimental sitagliptin/Pbo; pioglitazone/Pbo	Drug: 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.
4: Active Comparator pioglitazone/Pbo	Drug: 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.
5: Active Comparator pioglitazone/Pbo	Drug: 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.
6: Active Comparator pioglitazone/Pbo	Drug: 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.
7: Experimental sitagliptin/Pbo	Drug: sitagliptin phosphate sitagliptin 100mg tablets or Pbo taken once daily for a treatment period of 54 weeks.

Eligibility

Ages Eligible for Study:	18 Years to 78 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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 inhbitor (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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00722371

Contacts

Contact: Toll Free Number

1-888-577-8839

Show 102 Study Locations

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Additional Information:

MedWatch - FDA maintained medical product safety Information This link exits the ClinicalTrials.gov site

PhRMA Clinical Study Results Database - web-based repository for clinical study results This link exits the ClinicalTrials.gov site

Merck: Patient & Caregiver U.S. Product Web Site This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2008_522, MK0431-102
Study First Received:	July 22, 2008
Last Updated:	September 2, 2009
ClinicalTrials.gov Identifier:	NCT00722371 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Dipeptidyl-Peptidase IV Inhibitors
Hypoglycemic Agents
Metabolic Diseases
Pioglitazone
Diabetes Mellitus, Type 2
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Protease Inhibitors
Sitagliptin

Additional relevant MeSH terms:

Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Pioglitazone
Physiological Effects of Drugs
Diabetes Mellitus
Endocrine System Diseases
Enzyme Inhibitors

Pharmacologic Actions
Sitagliptin
Protease Inhibitors
Dipeptidyl-Peptidase IV Inhibitors
Hypoglycemic Agents
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on September 11, 2009