MK0431 Monotherapy Study in Patients With Type 2 Diabetes Mellitus (0431-040)

NCT ID: NCT00289848

Last Updated: 2015-06-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 530 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2007-03-31

Brief Summary

This is a clinical study to determine the safety and efficacy of an investigational drug in patients with 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

sitagliptin 100 mg

Group Type: EXPERIMENTAL

sitagliptin phosphate

Intervention Type: DRUG

Sitagliptin 100 mg administered as one oral tablet once daily before the morning meal for up to 18 weeks.

2

placebo

Group Type: PLACEBO_COMPARATOR

Comparator: placebo

Intervention Type: DRUG

placebo to match Sitagliptin 100 mg administered as one oral tablet once daily before the morning meal for up to 18 weeks

Interventions

sitagliptin phosphate

Sitagliptin 100 mg administered as one oral tablet once daily before the morning meal for up to 18 weeks.

Intervention Type: DRUG

Comparator: placebo

placebo to match Sitagliptin 100 mg administered as one oral tablet once daily before the morning meal for up to 18 weeks

Intervention Type: DRUG

Other Intervention Names

Januvia

Eligibility Criteria

Inclusion Criteria

• Patients have Type 2 Diabetes Mellitus and have laboratory results that are within the values established by the study such as an Hemoglobin A1c (HbA1c) >=7.5% and <=11% and a Fasting Plasma Glucose (FPG) >=130 mg/dL and <=280 mg/dL

Exclusion Criteria

• Patients have Type 1 Diabetes Mellitus or required insulin therapy within the past 12 months

• Minimum Eligible Age: 18 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

Mohan V, Yang W, Son HY, Xu L, Noble L, Langdon RB, Amatruda JM, Stein PP, Kaufman KD. Efficacy and safety of sitagliptin in the treatment of patients with type 2 diabetes in China, India, and Korea. Diabetes Res Clin Pract. 2009 Jan;83(1):106-16. doi: 10.1016/j.diabres.2008.10.009. Epub 2008 Dec 20.

Reference Type: BACKGROUND

PMID: 19097665 (View on PubMed)

Singh B, Sims H, Trueheart I, Simpson K, Wang KC, Patzkowsky K, Wegman T, Soma JM, Dixon R, Jayes F, Voegltine K, Yenokyan G, Su SC, Leppert P, Segars JH. A Phase I Clinical Trial to Assess Safety and Tolerability of Injectable Collagenase in Women with Symptomatic Uterine Fibroids. Reprod Sci. 2021 Sep;28(9):2699-2709. doi: 10.1007/s43032-021-00573-8. Epub 2021 Apr 29.

Reference Type: DERIVED

PMID: 33914296 (View on PubMed)

Other Identifiers

MK0431-040

Identifier Type: -

Identifier Source: secondary_id

2005_094

Identifier Type: -

Identifier Source: secondary_id

0431-040

Identifier Type: -

Identifier Source: org_study_id