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)

NCT00832390 | Completed Phase 4 Results

• 2 other identifiers: 0431-1582009_525
• Study Type: interventional
• Target: 29
• Locations: 0 countries
• Sites: N/A

Brief Summary

After 24 weeks of treatment evaluate the efficacy and security.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in A1C at Week 24

  Week 24 A1C minus baseline (Week 0) A1C. The unit for A1C is "percent". Thus, this measure represents a difference of percent values.

  Baseline and 24 Weeks

Study Arms (1)

1

EXPERIMENTAL

sitagliptin

Drug: sitagliptin phosphate

Interventions

sitagliptin phosphate DRUG

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

Also known as: MK0431

1

Eligibility Criteria

• Age: 30 Years - 78 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

Limitations and Caveats

Few participants were recruited into this single-site study as the investigator preferred the use of initial combination therapy. Protocol deviations may have occurred that resulted in quality issues associated with reporting of the data.

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 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2009
• First Posted: January 30, 2009
• Study Start: February 14, 2007
• Primary Completion: July 11, 2008
• Study Completion: July 11, 2008
• Last Updated: May 30, 2017
• Results First Posted: July 31, 2009

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share