Metformin Add-on Study in Patients With Type 2 Diabetes Mellitus (0431-020)(COMPLETED)

Diabetes Mellitus, Type II Clinical Trial

Official title:

A Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of the Addition of MK0431 to Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00086515
• Other study ID #: 0431-020
• Secondary ID: Formally-B0604T2
• Status: Completed
• Phase: Phase 3
• First received: July 2, 2004
• Last updated: April 27, 2015
• Start date: June 2004
• Est. completion date: February 2007

Study information

• Verified date: April 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 determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 701
• Est. completion date: February 2007
• Est. primary completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 78 Years

Eligibility

Inclusion Criteria:

• Patients with type 2 diabetes mellitus

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
• Diabetes Mellitus, Type II

Intervention

Drug:
• Sitagliptin (MK0431)
Sitagliptin 100 mg once daily, from Visit 4 through Final Visit, week 104
• Placebo/Glipizide 5 mg
Placebo (to match Sitagliptin 100 mg) from Visit 4 through Visit 8; Glipizide 5 mg from Visit 8, week 24 to Final Visit (Week 104)
• Metformin
Metformin 1500 mg, once daily, from Visit 2 to Final Visit (Week 104)
• Pioglitazone
Pioglitazone 15 mg once daily, for patients not meeting specific glycemic goals during the placebo-controlled treatment period [Phase A], from Visit 5 (Week 6) to Visit 8 (Week 24)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (2)

Charbonnel B, Karasik A, Liu J, Wu M, Meininger G; Sitagliptin Study 020 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin added to ongoing metformin therapy in patients with type 2 diabetes inadequately controlled with metformin alone. Diabetes Care. 2006 Dec;29(12):2638-43. — View Citation

Xu L, Man CD, Charbonnel B, Meninger G, Davies MJ, Williams-Herman D, Cobelli C, Stein PP. Effect of sitagliptin, a dipeptidyl peptidase-4 inhibitor, on beta-cell function in patients with type 2 diabetes: a model-based approach. Diabetes Obes Metab. 2008 Dec;10(12):1212-20. doi: 10.1111/j.1463-1326.2008.00887.x. Epub 2008 May 12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Hemoglobin A1C (A1C) at Week 24	A1C is measured as a percent. Thus, this change from; baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.	Baseline and Week 24	No
Secondary	Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24	Change from baseline at Week 24 is defined as FPG at; Week 24 minus FPG at Week 0.	Baseline and Week 24	No
Secondary	Change From Baseline in 2-hour Post-meal Glucose (PMG) at Week 24	Change from baseline at Week 24 is defined as PMG at Week 24 minus PMG at Week 0.	Baseline and Week 24	No