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NCT00690638 Clinical Trial

Safety and Efficacy Study of Dutogliptin/PHX1149T to Treat Type 2 Diabetes Mellitus

Type 2 Diabetes Mellitus Clinical Trial

Official title:
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate Safety and Efficacy of PHX1149T as Monotherapy in Subjects With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00690638
Other study ID # PHX1149-PROT301
Secondary ID EudraCT 2008-002
Status Completed
Phase Phase 3
First received June 2, 2008
Last updated April 12, 2010
Start date July 2008
Est. completion date April 2010

Study information
Verified date January 2010
Source Phenomix
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate Safety and Efficacy of PHX1149T as Monotherapy in Subjects with Type 2 Diabetes Mellitus

Recruitment information / eligibility
Status Completed
Enrollment 480
Est. completion date April 2010
Est. primary completion date January 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria:

- Type 2 diabetes mellitus, drug naïve or willing to wash-out from existing oral therapy

- BMI 25 to 48 kg/m2, inclusive

- HbA1c 7.0% - 10.0%, inclusive

- Age 18 to 75 years, inclusive

Exclusion Criteria:

- Currently on 3 or more oral antidiabetic drugs or insulin.

- 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

Intervention

Drug:
• PHX1149T
200 mg
• PHX1149T
400 mg
• Placebo
Placebo

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Phenomix Forest Laboratories

Countries where clinical trial is conducted

United States,  Argentina,  India,  Malaysia,  Peru,  Philippines,  Romania,  Thailand,  Ukraine, 

Outcome
Type Measure Description Time frame Safety issue
Primary To demonstrate changes in HbA1c Day 28 to Day 196 No
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