A Study of an Investigational Drug Sitagliptin for Type 2 Diabetes Mellitus (0431-044)

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Sitagliptin (MK0431) Late Phase II Double-Blind Dose-Response Study - Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00127192
• Other study ID #: 0431-044
• Secondary ID: MK0431-0442005_0
• Status: Completed
• Phase: Phase 2
• First received: August 3, 2005
• Last updated: May 20, 2015
• Start date: July 2005
• Est. completion date: March 2006

Study information

• Verified date: May 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

The purpose of this trial is to determine the efficacy and safety of an investigational drug in patients with type 2 diabetes mellitus.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 363
• Est. completion date: March 2006
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients with type 2 diabetes mellitus

Exclusion Criteria:

• Patients with type 1 diabetes mellitus

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• sitagliptin phosphate
sitagliptin phosphate 25 mg, 50 mg, 100 mg QD, or 200 mg QD 12-weeks.
• Comparator: placebo (unspecified)
placebo QD 12-weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Iwamoto Y, Taniguchi T, Nonaka K, Okamoto T, Okuyama K, Arjona Ferreira JC, Amatruda J. Dose-ranging efficacy of sitagliptin, a dipeptidyl peptidase-4 inhibitor, in Japanese patients with type 2 diabetes mellitus. Endocr J. 2010;57(5):383-94. Epub 2010 Ma — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in HbA1c at Week 12	HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the Week 0 HbA1c percent.	Baseline and Week 12	No
Secondary	Change From Baseline in Glycosylated Albumin at Week 12	Change from baseline at Week 12 is defined as Week 12 minus Week 0.	Baseline and Week 12	No
Secondary	Change From Baseline in Fasting Plasma Glucose at Week 12	Change from baseline at Week 12 is defined as Week 12 minus Week 0.	Baseline and Week 12	No