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

NCT ID: NCT00532935

Last Updated: 2017-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 517 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-26
• Study Completion Date: 2009-10-23

Brief Summary

A study to evaluate the efficacy and safety of MK0431A in comparison to a commonly used medication in patients with type 2 diabetes

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Sitagliptin phosphate (+) metformin hydrochloride

Group Type: EXPERIMENTAL

sitagliptin phosphate (+) metformin hydrochloride

Intervention Type: DRUG

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

2

pioglitazone

Group Type: ACTIVE_COMPARATOR

Comparator: pioglitazone

Intervention Type: DRUG

pioglitazone 30 mg tablet qd, titrating up to 45 mg qd for an \~32-wk treatment period.

Interventions

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

Intervention Type: DRUG

Comparator: pioglitazone

pioglitazone 30 mg tablet qd, titrating up to 45 mg qd for an \~32-wk treatment period.

Intervention Type: DRUG

Other Intervention Names

Janumet; pioglitazone

Eligibility Criteria

Inclusion Criteria

• Patient has type 2 diabetes mellitus
• Patient is inadequately controlled and not on treatment with insulin or oral antihyperglycemic therapy

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 78 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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 monotherapy in patients with type 2 diabetes. Diabetes Obes Metab. 2012 May;14(5):409-18. doi: 10.1111/j.1463-1326.2011.01530.x. Epub 2011 Dec 22.

Reference Type: RESULT

PMID: 22059736 (View on PubMed)

Other Identifiers

2007_510

Identifier Type: -

Identifier Source: secondary_id

0431A-066

Identifier Type: -

Identifier Source: org_study_id