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

NCT00289848 | Completed Phase 3 Results

• 3 other identifiers: 0431-040MK0431-0402005_094
• Study Type: interventional
• Target: 530
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Hemoglobin A1c (HbA1c) at Week 18

  A1C was measured as a 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)

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

  Baseline and Week 18

• Change From Baseline in 2-hr Post-Meal Glucose (PMG) at Week 18

  Baseline and Week 18

Study Arms (2)

1

EXPERIMENTAL

sitagliptin 100 mg

Drug: sitagliptin phosphate

2

PLACEBO COMPARATOR

placebo

Drug: Comparator: placebo

Interventions

sitagliptin phosphate DRUG

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

Also known as: Januvia

1

Comparator: placebo DRUG

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

2

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (2)

• 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.

  PMID: 19097665 BACKGROUND

• 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.

  PMID: 33914296 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sitagliptin Phosphate

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

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: February 7, 2006
• First Posted: February 10, 2006
• Study Start: March 1, 2006
• Primary Completion: March 1, 2007
• Study Completion: March 1, 2007
• Last Updated: June 15, 2015
• Results First Posted: April 2, 2010

Record last verified: 2015-05