Initial Combination With Pioglitazone Study
Information source: Merck
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes Mellitus
Intervention: sitagliptin phosphate (Drug); Comparator : pioglitazone hydrochloride (Drug); Comparator : Placebo (unspecified) (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
Overall contact:
Toll Free Number, Phone: 1-888-577-8839
Summary
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.
Clinical Details
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
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: HbA1cSafety and tolerability
Secondary outcome: 2-hr PPGFPG FPG HOMA-b, insulinogenic index, proinsulin to insulin ratio, and glucose AUC/insulin AUC
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Toll Free Number, Phone: 1-888-577-8839
Merck Sharp & Dohme (I.A.) Corporation, Makati City 1229, Philippines; Recruiting
Cesar "Butch" Recto II, Phone: 632-885-0700
Additional Information
(MedWatch - FDA maintained medical product safety Information) (PhRMA Clinical Study Results Database - web-based repository for clinical study results) (Merck: Patient & Caregiver U.S. Product Web Site)
Starting date: December 2006
Last updated: June 11, 2008
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