Initial Combination With Pioglitazone Study - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00397631

Purpose

A clinical study to evaluate the safety and efficacy of the initial combination therapy with sitagliptin and pioglitazone in patients with type 2 diabetes mellitus not on treatment with insulin or oral antihyperglycemic therapy.

Condition	Intervention	Phase
Type 2 Diabetes Mellitus	Drug: sitagliptin 100 mg q.d./pioglitazone 30 mg q.d Drug: Comparator: placebo to match sitagliptin 100 mg q.d./pioglitazone 30 mg q.d.	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of the Initial Therapy With Coadministration of Sitagliptin and Pioglitazone in Patients With Type 2 Diabetes Mellitus

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2

Drug Information available for: Pioglitazone Pioglitazone hydrochloride Sitagliptin Sitagliptin phosphate

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24 [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent.

Secondary Outcome Measures:

Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
Change from baseline at Week 24 is defined as Week 24 minus Week 0.
Change From Baseline in 2-hour PPG (Post-prandial Glucose) at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
Change from baseline at Week 24 is defined as Week 24 minus Week 0.

Enrollment:	520
Study Start Date:	December 2006
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 sitagliptin 100 mg q.d./pioglitazone 30 mg q.d.	Drug: sitagliptin 100 mg q.d./pioglitazone 30 mg q.d Patients will receive initial combination therapy with blinded sitagliptin 100 mg q.d. and open- label pioglitazone 30 mg q.d. for up to 24 Weeks. Sitagliptin 100 mg q.d. and pioglitazone 30 mg q.d. will be administered as oral tablets.
Active Comparator: 2 sitagliptin 100 mg placebo q.d./pioglitazone 30 mg q.d.	Drug: Comparator: placebo to match sitagliptin 100 mg q.d./pioglitazone 30 mg q.d. Patients will receive placebo to match sitagliptin 100 mg q.d. (blinded) and open label pioglitazone 30 mg q.d. for up to 24 Weeks. Placebo to match sitagliptin 100 mg q.d.(blinded) and open-label pioglitazone 30 mg q.d. will be administered as oral tablets.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

General Inclusion Criteria:

Patients ≥18 years old with Type 2 Diabetes Mellitus (a specific type of diabetes)

General Exclusion Criteria:

Patient has a history of type 1 diabetes mellitus or history of ketoacidosis
Patient was on antihyperglycemic agent therapy (oral or insulin) within the prior 4 months
Patient was on >4 weeks (cumulatively) of antihyperglycemic therapy (oral or insulin) over the prior 2 years

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00397631

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

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

No publications provided

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00397631 History of Changes
Other Study ID Numbers:	2006_531, MK0431-064
Study First Received:	November 8, 2006
Results First Received:	May 19, 2009
Last Updated:	April 20, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pioglitazone
Sitagliptin

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012