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NCT00530881 Clinical Trial

Randomized, Double-Blind, Placebo-Controlled, With PHX1149 in Patients With Type 2 Diabetes Mellitus

Type 2 Diabetes Mellitus Clinical Trial

Official title:
A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Examine Safety and Establish Proof of Concept With PHX1149 in Patients With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00530881
Other study ID # PHX1149-Prot201
Secondary ID
Status Completed
Phase Phase 2
First received September 14, 2007
Last updated September 17, 2007
Start date April 2006
Est. completion date October 2006

Study information
Verified date September 2007
Source Phenomix
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This will be a 4-week, multicenter, randomized, double-blind, parallel group, placebo-controlled, safety, tolerability, and efficacy study. Patients will be screened and be on one of three doses of PHX1149 (a new drug candidate for the treatment of Type 2 diabetes ) or placebo. The drug is a "DPP4 inhibitor"

Recruitment information / eligibility
Status Completed
Enrollment 180
Est. completion date October 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Type 2 diabetes mellitus treatment with metformin +/- TZD

Exclusion Criteria:

- Type 1 diabetes mellitus

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• PHX1149

Locations
Country Name City State
United States Multiple Sites san Diego California

Sponsors (1)
Lead Sponsor Collaborator
Phenomix

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary postprandial blood glucose
Secondary fasting blood glucose, HbA1c, safety
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