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NCT00832390 Clinical Trial

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)

Diabetes Mellitus Clinical Trial

Official title:
Study to Assess the Efficacy and Safety of Sitagliptin in Recently Diagnosed, Naive Type 2 Diabetics With Inadequate Glycemic Control on Diet and Exercise

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00832390
Other study ID # 0431-158
Secondary ID 2009_525
Status Completed
Phase Phase 4
First received January 28, 2009
Last updated February 3, 2016
Start date February 2007
Est. completion date July 2008

Study information
Verified date February 2016
Source Merck Sharp & Dohme Corp.
Contact n/a
Is FDA regulated No
Health authority Mexico: Ministry of Health
Study type Interventional

Clinical Trial Summary

After 24 weeks of treatment evaluate the efficacy and security.

Recruitment information / eligibility
Status Completed
Enrollment 29
Est. completion date July 2008
Est. primary completion date July 2008
Accepts healthy volunteers No
Gender Both
Age group 30 Years to 78 Years
Eligibility Inclusion Criteria:

- Patients Being Treated With Metformin

- Patients With Hba1c Between 6.5 % And 12.0%.

- Type 2 DM

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• sitagliptin phosphate
Patients will receive sitagliptin with metformin for 24 weeks, given as oral tablets

Locations
Country Name City State
n/a

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

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
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