MK0431A vs. Pioglitazone in Patients With Type 2 Diabetes Mellitus (0431A-066)

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A Phase III Randomized, Active-Comparator (Pioglitazone) Controlled Clinical Trial to Study the Efficacy and Safety of the MK0431A (A Fixed-Dose Combination Tablet of Sitagliptin and Metformin) in Patients With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00532935
• Other study ID #: 0431A-066
• Secondary ID: 2007_510
• Status: Completed
• Phase: Phase 3
• First received: September 19, 2007
• Last updated: December 16, 2015
• Start date: January 2008
• Est. completion date: October 2009

Study information

• Verified date: December 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 study to evaluate the efficacy and safety of MK0431A in comparison to a commonly used medication in patients with type 2 diabetes

Recruitment information / eligibility

• Status: Completed
• Enrollment: 517
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 78 Years

Eligibility

General Inclusion Criteria:

• Patient has type 2 diabetes mellitus

• Patient is inadequately controlled and not on treatment with insulin or oral antihyperglycemic therapy

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 12 weeks

• Patient was on >4 weeks (cumulatively) of antihyperglycemic therapy (oral or insulin) over the prior 3 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 phosphate (+) metformin hydrochloride
sitagliptin phosphate (+) metformin hydrochloride 50/500 mg tablet bid, titrating up to sitagliptin phosphate (+) metformin hydrochloride 50/1000 mg tablet for an ~32 wk treatment period
• Comparator: pioglitazone
pioglitazone 30 mg tablet qd, titrating up to 45 mg qd for an ~32-wk treatment period.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Wainstein J, Katz L, Engel SS, Xu L, Golm GT, Hussain S, O'Neill EA, Kaufman KD, Goldstein BJ. Initial therapy with the fixed-dose combination of sitagliptin and metformin results in greater improvement in glycaemic control compared with pioglitazone mono — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in A1C at Week 32	A1C is measured as a percent. Thus this change from baseline reflects the Week 32 A1C percent minus the baseline A1C percent	Baseline and Week 32	No
Secondary	Change From Baseline in Fasting Plasma Glucose (FPG) at Week 1	Change from baseline reflects the Week 1 FPG minus the baseline FPG. At Week 1, the dose was 50/500 mg b.i.d. for Sita/Met FDC and 30 mg q.d. for pioglitazone	Baseline and Week 1	No
Secondary	Change From Baseline in 2-hour Post-Meal Glucose (PMG) at Week 32	Change from baseline reflects the Week 32 2-hour PMG minus the baseline 2-hour PMG	Baseline and Week 32	No
Secondary	Change From Baseline in FPG at Week 32	Change from baseline reflects the Week 32 FPG minus the baseline FPG	Baseline and Week 32	No
Secondary	Percent of Participants With A1C <7.0% at Week 32		Week 32	No