A Study to Evaluate the Efficacy and Safety of Sitagliptin and MK0431A in Comparison to a Commonly Used Medication in Patients With Type 2 Diabetes - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00541450

Purpose

A study to evaluate the efficacy and safety of Sitagliptin and MK0431A in comparison to a commonly used medication in patients with type 2 diabetes.

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

MedlinePlus related topics: Diabetes

Drug Information available for: Pioglitazone Pioglitazone hydrochloride Metformin Metformin hydrochloride Sitagliptin phosphate Sitagliptin

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase III Randomized, Active-Comparator (Pioglitazone) Controlled Clinical Trial to Study the Efficacy and Safety of Sitagliptin and MK0431A (A Fixed-Dose Combination Tablet of Sitagliptin and Metformin) in Patients With Type 2 Diabetes Mellitus

Further study details as provided by Merck:

Primary Outcome Measures:

HbA1c after 40 weeks; Efficacy and safety [ Time Frame: 40 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

HbA1c after 12 weeks, 2-hour postprandial glucose and fasting plasma glucose. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	466
Study Start Date:	January 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Phase A: Experimental Phase A: Drug	Drug: Comparator: sitagliptin phosphate sitagliptin 100mg tablet q.d. for a 4-wk treatment period. Drug: Comparator: sitagliptin phosphate (+) metformin hydrochloride sitagliptin/metformin HCL 50/1000mg bid. for a 34-wk treatment period
Phase B: Active Comparator Phase B: Active comparator	Drug: Comparator: pioglitazone pioglitazone 15mg tablet qd, titrating up to 45mg qd, for a 34-wk treatment period

Eligibility

Criteria

Inclusion Criteria:

Patients between the ages of 18 and 78 with type 2 diabetes mellitus
Patient has not been on any antihyperglycemic agent (Insulin or oral) in the last 3 months

Exclusion Criteria:

Patient has a history of type 1 diabetes mellitus or a history of ketoacidosis
Patient has previously been treated with sitagliptin or has previously been in a study using a DPP-4 inhibitor

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00541450

Contacts

Contact: Toll Free Number

1-888-577-8839

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

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:	2007_501, MK0431-068
Study First Received:	October 5, 2007
Last Updated:	January 14, 2009
ClinicalTrials.gov Identifier:	NCT00541450
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Metabolic Diseases
Pioglitazone
Metformin
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 January 16, 2009