An Investigational Drug Study in Patients With Type 2 Diabetes Mellitus (MK0431-023)

NCT00094757 | Completed Phase 3 Results

• 2 other identifiers: 0431-0232004_045
• Study Type: interventional
• Target: 521
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine the safety and effectiveness of an investigational drug in patients with Type 2 Diabetes Mellitus.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in A1C at Week 18

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

  Weeks 0-18

Secondary Outcomes (3)

• Change From Baseline in FPG at Week 18

  Weeks 0-18

• Change From Baseline in A1C at Week 54

  Weeks 0-54

• Change From Baseline in FPG at Week 54

  Weeks 0-54

Study Arms (3)

Sitagliptin 100 mg

EXPERIMENTAL

Sitagliptin 100 mg

Drug: Comparator: sitagliptin 100 mg

Sitagliptin 200 mg

EXPERIMENTAL

Sitagliptin 200 mg

Drug: Comparator: sitagliptin 200 mg

Placebo/Pioglitazone

PLACEBO COMPARATOR

Placebo/Pioglitazone

Drug: Comparator: placebo; Drug: Comparator: pioglitazone

Interventions

Comparator: sitagliptin 100 mg DRUG

sitagliptin 100 mg oral tablet once daily for 54 weeks

Sitagliptin 100 mg

Comparator: sitagliptin 200 mg DRUG

sitagliptin 200 mg (2- 100 mg oral tablets) once daily for 54 weeks

Sitagliptin 200 mg

Comparator: placebo DRUG

placebo oral tablet once daily during Phase A (Weeks 0-18)

Placebo/Pioglitazone

Comparator: pioglitazone DRUG

pioglitazone 30 mg oral tablet once daily during Phase B (Weeks 18-54)

Placebo/Pioglitazone

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients at least 18 years of age and not older than 75 who have a specific type of diabetes called Type 2 Diabetes Mellitus

You may not qualify if:

• Younger than 18 years of age or older than 75
• Any condition, which in the opinion of the investigator, may not be in the patient's best interest to participate

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Raz I, Hanefeld M, Xu L, Caria C, Williams-Herman D, Khatami H; Sitagliptin Study 023 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin as monotherapy in patients with type 2 diabetes mellitus. Diabetologia. 2006 Nov;49(11):2564-71. doi: 10.1007/s00125-006-0416-z. Epub 2006 Sep 26.

  PMID: 17001471 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Results Point of Contact

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

ClinicalTrialsDisclosure@merck.com

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: October 22, 2004
• First Posted: October 25, 2004
• Study Start: October 6, 2004
• Primary Completion: August 17, 2005
• Study Completion: April 28, 2006
• Last Updated: May 30, 2019
• Results First Posted: July 21, 2010

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will share