Initial Combination With Pioglitazone Study - Full Text View

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
Type 2 Diabetes Mellitus	Drug: sitagliptin phosphate Drug: Comparator : pioglitazone hydrochloride Drug: Comparator : Placebo (unspecified)

MedlinePlus related topics:

Diabetes

Drug Information available for:

Pioglitazone Pioglitazone hydrochloride Sitagliptin phosphate Sitagliptin

U.S. FDA Resources

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 to Evaluate the Safety and Efficacy of the Initial Therapy With Coadministration of Sitagliptin and Pioglitazone in Patients With Type 2 Diabetes Mellitus

Further study details as provided by Merck:

Primary Outcome Measures:

HbA1c [ Time Frame: After 24 weeks ] [ Designated as safety issue: No ]
Safety and tolerability [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

2-hr PPG [ Time Frame: After 2 Hours ] [ Designated as safety issue: No ]
FPG [ Time Frame: After 24 weeks ] [ Designated as safety issue: No ]
FPG [ Time Frame: After 1 week ] [ Designated as safety issue: No ]
HOMA-b, insulinogenic index, proinsulin to insulin ratio, and glucose AUC/insulin AUC [ Time Frame: After 24 weeks ] [ Designated as safety issue: No ]

Enrollment:	350
Study Start Date:	December 2006
Study Completion Date:	July 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 sitagliptin 50mg Pbo tablets/pioglitazone 30mg tablet qd	Drug: sitagliptin phosphate sitagliptin 50mg tablets qd. For 24 Weeks of treatment. Drug: Comparator : pioglitazone hydrochloride pioglitazone 30mg tablet qd. For 24 Weeks of Treatment. Drug: Comparator : Placebo (unspecified) sitagliptin 50mg Pbo tablets. for 24 Weeks of treatment.
2 sitagliptin 50mg tablets/pioglitazone 30mg tablet qd	Drug: Comparator : pioglitazone hydrochloride pioglitazone 30mg tablet qd. For 24 Weeks of Treatment.

Eligibility

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

Criteria

Inclusion Criteria:

Patient has type 2 diabetes mellitus
Patient is inadequately controlled and not on treatment with insulin or oral antihyperglycemic therapy

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

(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

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2006_531, MK0431-064
First Received:	November 8, 2006
Last Updated:	August 7, 2008
ClinicalTrials.gov Identifier:	NCT00397631
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Metabolic Diseases

Pioglitazone

Diabetes Mellitus, Type 2

Diabetes Mellitus

Endocrine System Diseases

Endocrinopathy

Metabolic disorder

Glucose Metabolism Disorders

Sitagliptin

Additional relevant MeSH terms:

Dipeptidyl-Peptidase IV Inhibitors

Hypoglycemic Agents

Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs

Enzyme Inhibitors

Pharmacologic Actions

Protease Inhibitors

ClinicalTrials.gov processed this record on October 29, 2008

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