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NCT00094757 Clinical Trial

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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
A Multicenter, Randomized, Double-Blind Study of MK0431 in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00094757
Other study ID # 0431-023
Secondary ID 2004_045
Status Completed
Phase Phase 3
First received
Last updated
Start date October 6, 2004
Est. completion date April 28, 2006

Study information
Verified date May 2019
Source Merck Sharp & Dohme Corp.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 521
Est. completion date April 28, 2006
Est. primary completion date August 17, 2005
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Comparator: sitagliptin 100 mg
sitagliptin 100 mg oral tablet once daily for 54 weeks
• Comparator: sitagliptin 200 mg
sitagliptin 200 mg (2- 100 mg oral tablets) once daily for 54 weeks
• Comparator: placebo
placebo oral tablet once daily during Phase A (Weeks 0-18)
• Comparator: pioglitazone
pioglitazone 30 mg oral tablet once daily during Phase B (Weeks 18-54)

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Merck Sharp & Dohme Corp.

References & 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. Epub 2006 Sep 26. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Change From Baseline in FPG at Week 18 The change from baseline reflects the Week 18 Fasting Plasma Glucose (FPG) minus the Week 0 FPG. Weeks 0-18
Secondary Change From Baseline in A1C at Week 54 A1C is measured as percent. Thus this change from baseline reflects the Week 54 A1C percent minus the Week 0 A1C percent. Weeks 0-54
Secondary Change From Baseline in FPG at Week 54 The change from baseline reflects the Week 54 FPG minus the Week 0 FPG. Weeks 0-54
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