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

NCT00482729 | Completed Phase 3 Results

• 3 other identifiers: 0431A-079MK0431A-0792007_548
• Study Type: interventional
• Target: 1,246
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Hemoglobin A1c (A1C) at Week 18

  A1C is measured as percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.

  Baseline and Week 18

Secondary Outcomes (2)

• Number of Patients With A1C < 7.0% at Week 18

  Week 18

• Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18

  Baseline and Week 18

Other Outcomes (2)

• Change From Baseline in A1C at Week 44

  Baseline and Week 44

• Number of Patients With A1C < 7.0% at Week 44

  Week 44

Study Arms (2)

1

EXPERIMENTAL

Arm 1: drug

Drug: sitagliptin phosphate (+) metformin hydrochloride

2

ACTIVE COMPARATOR

Arm 2: active comparator

Drug: metformin

Interventions

sitagliptin phosphate (+) metformin hydrochloride 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.

Also known as: MK0431A, Janumet™

1

metformin DRUG

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

2

Eligibility Criteria

• Age: 18 Years - 78 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patient has type 1 diabetes mellitus or history of ketoacidosis

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (2)

• 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.

  PMID: 21410627 RESULT

• 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.

  PMID: 21535346 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sitagliptin Phosphate; Metformin; Sitagliptin Phosphate, Metformin Hydrochloride Drug Combination

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Biguanides; Guanidines; Amidines; Organic Chemicals; Drug Combinations; Pharmaceutical Preparations

Limitations and Caveats

Site 079011301 was non-compliant with Good Clinical Practice (GCP). Data from the 4 patients at this site are included in the Participant Flow summary, but are excluded from all other summaries and analyses.

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2007
• First Posted: June 5, 2007
• Study Start: June 19, 2007
• Primary Completion: November 3, 2008
• Study Completion: April 27, 2009
• Last Updated: June 9, 2017
• Results First Posted: March 15, 2010

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share