MK0431A Comparative Study in Patients With Type 2 Diabetes (0431A-079)(COMPLETED)

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A Randomized, Double-Blind, Active-Comparator Controlled, Clinical Trial to Study the Efficacy and Safety of MK0431A for the Treatment of Patients With Type 2 Diabetes Mellitus (T2DM)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00482729
• Other study ID #: 0431A-079
• Secondary ID: MK0431A-0792007_
• Status: Completed
• Phase: Phase 3
• First received: May 31, 2007
• Last updated: February 20, 2015
• Start date: June 2007
• Est. completion date: April 2009

Study information

• Verified date: February 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the efficacy and safety of an investigational treatment for type 2 diabetes mellitus.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1246
• Est. completion date: April 2009
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 78 Years

Eligibility

Inclusion Criteria:

• Patient has type 2 diabetes mellitus

• Patient is greater than or equal to 18 and less than or equal to 78 years of age on the day of signing the consent

• Patient has Hb1Ac greater than or equal to 7.5% and is appropriate for oral therapy

• Patient has not been on any antihyperglycemic agent (AHA) in the last 4 months

• Patient is a male, or a female who is unlikely to conceive

Exclusion Criteria:

• Patient has type 1 diabetes mellitus or history of ketoacidosis

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• sitagliptin phosphate (+) metformin hydrochloride
sitagliptin/Metformin HCl 50/500 mg tablet bid, titrating up to sitagliptin/Metformin HCl 50/1000 mg tablet over 4 weeks; for a 44-wk treatment period.
• metformin
metformin 500 mg tablet bid, titrating up to 1000 mg tablets bid for a 44-wk treatment period

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (2)

Olansky L, Reasner C, Seck TL, Williams-Herman DE, Chen M, Terranella L, Mehta A, Kaufman KD, Goldstein BJ. A treatment strategy implementing combination therapy with sitagliptin and metformin results in superior glycaemic control versus metformin monothe — View Citation

Reasner C, Olansky L, Seck TL, Williams-Herman DE, Chen M, Terranella L, Johnson-Levonas AO, Kaufman KD, Goldstein BJ. The effect of initial therapy with the fixed-dose combination of sitagliptin and metformin compared with metformin monotherapy in patien — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change From Baseline in A1C at Week 44	A1C is measured as percent. Thus, this change from baseline reflects the Week 44 A1C percent minus the Week 0 A1C percent.	Baseline and Week 44	No
Other	Number of Patients With A1C < 7.0% at Week 44		Week 44	No
Primary	Change From Baseline in Hemoglobin A1c (A1C) at Week 18	A1C is measured as percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.	Baseline and Week 18	No
Secondary	Number of Patients With A1C < 7.0% at Week 18		Week 18	No
Secondary	Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18	FPG is measured as mg/dL. Thus, this change from baseline reflects the Week 18 FPG mg/dL minus the Week 0 FPG mg/dL.	Baseline and Week 18	No

External Links

•   (MedWatch - FDA maintained medical product safety Information)
•   (Merck: Patient & Caregiver U.S. Product Web Site)