Initial Combination With Pioglitazone Study (0431-064)

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00397631
• Other study ID #: 0431-064
• Secondary ID: MK0431-0642006_5
• Status: Completed
• Phase: Phase 3
• First received: November 8, 2006
• Last updated: January 27, 2015
• Start date: December 2006
• Est. completion date: June 2008

Study information

• Verified date: January 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 520
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

General Inclusion Criteria:

• Patients =18 years old with Type 2 Diabetes Mellitus (a specific type of diabetes)

General 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

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 100 mg q.d./pioglitazone 30 mg q.d
Patients will receive initial combination therapy with blinded sitagliptin 100 mg q.d. and open- label pioglitazone 30 mg q.d. for up to 24 Weeks. Sitagliptin 100 mg q.d. and pioglitazone 30 mg q.d. will be administered as oral tablets.
• Comparator: placebo to match sitagliptin 100 mg q.d./pioglitazone 30 mg q.d.
Patients will receive placebo to match sitagliptin 100 mg q.d. (blinded) and open label pioglitazone 30 mg q.d. for up to 24 Weeks. Placebo to match sitagliptin 100 mg q.d.(blinded) and open-label pioglitazone 30 mg q.d. will be administered as oral tablets.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Yoon KH, Shockey GR, Teng R, Golm GT, Thakkar PR, Meehan AG, Williams-Herman DE, Kaufman KD, Amatruda JM, Steinberg H. Effect of initial combination therapy with sitagliptin, a dipeptidyl peptidase-4 inhibitor, and pioglitazone on glycemic control and mea — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24	HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent.	Baseline and 24 weeks	No
Secondary	Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24	Change from baseline at Week 24 is defined as Week 24 minus Week 0.	Baseline and Week 24	No
Secondary	Change From Baseline in 2-hour PPG (Post-prandial Glucose) at Week 24	Change from baseline at Week 24 is defined as Week 24 minus Week 0.	Baseline and Week 24	No

External Links

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