MK0431 (Sitagliptin) Pioglitazone Add-on Study for Patients With Type 2 Diabetes Mellitus (0431-055)(COMPLETED)

Type 2 Diabetes Mellitus Clinical Trial

Official title:

MK0431 (Sitagliptin) Phase III Clinical Study -Pioglitazone add-on Study for Patients With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00372060
• Other study ID #: 0431-055
• Secondary ID: 2006_029
• Status: Completed
• Phase: Phase 3
• First received: September 5, 2006
• Last updated: February 3, 2016
• Start date: August 2006
• Est. completion date: February 2008

Study information

• Verified date: February 2016
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

The clinical study determines the safety and efficacy of MK0431 in patients with type 2 diabetes mellitus who have inadequate glycemic control on pioglitazone as monotherapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Patients Have Type 2 Diabetes Mellitus

• On Diet/Exercise Therapy And Pioglitazone As Monotherapy

Exclusion Criteria:

• Patients Have Type 1 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
• Type 2 Diabetes Mellitus

Intervention

Drug:
• sitagliptin phosphate
Sitagliptin (MK0431) 50 or 100 mg once daily for 52 weeks
• Comparator: sitagliptin phosphate (MK0431)
Sitagliptin (MK0431) 50 or 100 mg once daily for 40 weeks
• Comparator: pioglitazone
pioglitazone once daily for 52 weeks
• Comparator: placebo (unspecified)
Placebo once daily for 12 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Kashiwagi A, Kadowaki T, Tajima N, Nonaka K, Taniguchi T, Nishii M, Ferreira JC, Amatruda JM. Sitagliptin added to treatment with ongoing pioglitazone for up to 52 weeks improves glycemic control in Japanese patients with type 2 diabetes. J Diabetes Investig. 2011 Oct 7;2(5):381-90. doi: 10.1111/j.2040-1124.2011.00120.x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change From Baseline in 2 Hour Postprandial Glucose at Week 12	Change from baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication.	12 weeks	No
Other	Change From Baseline in Hemoglobin A1c (HbA1c ) at Week 52	Change from the last value before receiving sitagliptin therapy: Week 0 for Sitagliptin/Sitagliptin group and Week 12 for the Placebo/Sitagliptin group.	Week 52 (reflecting change from Week 0) for Sitagliptin/Sitagliptin group; Weeks 52 (reflecting change from Week 12) for Placebo/Sitagliptin group.	No
Primary	Change From Baseline in Hemoglobin A1c (HbA1c ) at Week 12	Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication.	12 Weeks	No
Secondary	Change From Baseline in Fasting Plasma Glucose at Week 12	Change from baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication.	12 Weeks	No

External Links

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