MK0431A Comparative Study in Patients With Type 2 Diabetes (0431A-079)(COMPLETED)

NCT ID: NCT00482729

Last Updated: 2017-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1246 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-19
• Study Completion Date: 2009-04-27

Brief Summary

The purpose of this study is to investigate the efficacy and safety of an investigational treatment for type 2 diabetes mellitus.

Conditions

Type 2 Diabetes Mellitus

Study Design

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

Study Groups

1

Arm 1: drug

Group Type: EXPERIMENTAL

sitagliptin phosphate (+) metformin hydrochloride

Intervention Type: DRUG

sitagliptin/Metformin HCl 50/500 mg tablet bid, titrating up to sitagliptin/Metformin HCl 50/1000 mg tablet over 4 weeks; for a 44-wk treatment period.

2

Arm 2: active comparator

Group Type: ACTIVE_COMPARATOR

metformin

Intervention Type: DRUG

metformin 500 mg tablet bid, titrating up to 1000 mg tablets bid for a 44-wk treatment period

Interventions

sitagliptin phosphate (+) metformin hydrochloride

sitagliptin/Metformin HCl 50/500 mg tablet bid, titrating up to sitagliptin/Metformin HCl 50/1000 mg tablet over 4 weeks; for a 44-wk treatment period.

Intervention Type: DRUG

metformin

metformin 500 mg tablet bid, titrating up to 1000 mg tablets bid for a 44-wk treatment period

Intervention Type: DRUG

Other Intervention Names

MK0431A; Janumet™

Eligibility Criteria

Inclusion Criteria

• Patient has type 2 diabetes mellitus
• Patient is greater than or equal to 18 and less than or equal to 78 years of age on the day of signing the consent
• Patient has Hb1Ac greater than or equal to 7.5% and is appropriate for oral therapy
• Patient has not been on any antihyperglycemic agent (AHA) in the last 4 months
• Patient is a male, or a female who is unlikely to conceive

Exclusion Criteria

• Patient has type 1 diabetes mellitus or history of ketoacidosis

• 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

Reasner C, Olansky L, Seck TL, Williams-Herman DE, Chen M, Terranella L, Johnson-Levonas AO, Kaufman KD, Goldstein BJ. The effect of initial therapy with the fixed-dose combination of sitagliptin and metformin compared with metformin monotherapy in patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2011 Jul;13(7):644-52. doi: 10.1111/j.1463-1326.2011.01390.x.

Reference Type: RESULT

PMID: 21410627 (View on PubMed)

Olansky L, Reasner C, Seck TL, Williams-Herman DE, Chen M, Terranella L, Mehta A, Kaufman KD, Goldstein BJ. A treatment strategy implementing combination therapy with sitagliptin and metformin results in superior glycaemic control versus metformin monotherapy due to a low rate of addition of antihyperglycaemic agents. Diabetes Obes Metab. 2011 Sep;13(9):841-9. doi: 10.1111/j.1463-1326.2011.01416.x.

Reference Type: RESULT

PMID: 21535346 (View on PubMed)

Other Identifiers

MK0431A-079

Identifier Type: -

Identifier Source: secondary_id

2007_548

Identifier Type: -

Identifier Source: secondary_id

0431A-079

Identifier Type: -

Identifier Source: org_study_id