- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00530881
Randomized, Double-Blind, Placebo-Controlled, With PHX1149 in Patients With Type 2 Diabetes Mellitus
September 17, 2007 updated by: Phenomix
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"
Study Overview
Study Type
Interventional
Enrollment (Actual)
180
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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san Diego, California, United States, 92121
- Multiple Sites
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Type 2 diabetes mellitus treatment with metformin +/- TZD
Exclusion Criteria:
- Type 1 diabetes mellitus
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 4
|
|
Placebo Comparator: 3 active, 1 placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
postprandial blood glucose
|
Secondary Outcome Measures
Outcome Measure |
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fasting blood glucose, HbA1c, safety
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Hans-Peter Guler, MD, Phenomix Corp.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2006
Study Completion (Actual)
October 1, 2006
Study Registration Dates
First Submitted
September 14, 2007
First Submitted That Met QC Criteria
September 17, 2007
First Posted (Estimate)
September 18, 2007
Study Record Updates
Last Update Posted (Estimate)
September 18, 2007
Last Update Submitted That Met QC Criteria
September 17, 2007
Last Verified
September 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PHX1149-Prot201
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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