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

This study has been completed.
Sponsor:
Information provided by:
Phenomix
ClinicalTrials.gov Identifier:
NCT00530881
First received: September 14, 2007
Last updated: September 17, 2007
Last verified: September 2007

September 14, 2007
September 17, 2007
April 2006
Not Provided
postprandial blood glucose
Same as current
Complete list of historical versions of study NCT00530881 on ClinicalTrials.gov Archive Site
fasting blood glucose, HbA1c, safety
Same as current
Not Provided
Not Provided
 
Randomized, Double-Blind, Placebo-Controlled, With PHX1149 in Patients With Type 2 Diabetes Mellitus
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

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"

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
Drug: PHX1149
  • Placebo Comparator: 4
    Intervention: Drug: PHX1149
  • Placebo Comparator: 3 active, 1 placebo
    Intervention: Drug: PHX1149
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
180
October 2006
Not Provided

Inclusion Criteria:

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

Exclusion Criteria:

  • Type 1 diabetes mellitus
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00530881
PHX1149-Prot201
No
Not Provided
Phenomix
Not Provided
Study Director: Hans-Peter Guler, MD Phenomix Corp.
Phenomix
September 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP