Study to Assess the Efficacy and Safety of Sitagliptin in Recently Diagnosed, Naive Type 2 Diabetics With Inadequate Glycemic Control on Diet and Exercise (0431-158)

NCT ID: NCT00832390

Last Updated: 2017-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-14
• Study Completion Date: 2008-07-11

Brief Summary

After 24 weeks of treatment evaluate the efficacy and security.

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

sitagliptin

Group Type: EXPERIMENTAL

sitagliptin phosphate

Intervention Type: DRUG

Patients will receive sitagliptin with metformin for 24 weeks, given as oral tablets

Interventions

sitagliptin phosphate

Patients will receive sitagliptin with metformin for 24 weeks, given as oral tablets

Intervention Type: DRUG

Other Intervention Names

MK0431

Eligibility Criteria

Inclusion Criteria

• Patients Being Treated With Metformin
• Patients With Hba1c Between 6.5 % And 12.0%.
• Type 2 DM

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 78 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

Other Identifiers

2009_525

Identifier Type: -

Identifier Source: secondary_id

0431-158

Identifier Type: -

Identifier Source: org_study_id