Back to resultsA Study to Evaluate Safety and Efficacy of PHX1149T in Subjects With Type 2 Diabetes Mellitus
Primary Purpose
Type 2 Diabetes Mellitus
Status
Unknown status
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
PHX1149T
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus
Eligibility Criteria
Key Entry Criteria:
- Type 2 diabetes mellitus, diagnosed at least 4 months but not more than 12 years prior to screening.
- Male and non-pregnant, non-lactating (and not planning to become pregnant during the study) female subjects with a BMI of 25 to 48 kg/m2, inclusive. For India the BMI is 23 to 48 kg/m2, inclusive.
- Current treatment of Type 2 diabetes mellitus with a stable dose of metformin of 1500 mg or more (or the highest tolerated dose), or TZD (any labeled dose), or metformin + TZD at doses used in accordance with product labeling for at least 4 weeks (metformin) or 10 weeks (TZD) prior to screening (Visit 1).
- Fasting plasma glucose of 118 - 220 mg/dL (6.6 - 12.2 mmol/L), inclusive; HbA1c 7.3% - 11.0%, inclusive; and a fasting plasma C peptide greater than 0.26 nmol/L at screening. For Argentina the allowed upper limit of HbA1c is ≤ 10.5%. For Canada the upper limit will be 10.0%
- No Type 1 diabetes mellitus or marked diabetic long-term complications.
Sites / Locations
Outcomes
Primary Outcome Measures
HbA1c
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00482950
Brief Title
A Study to Evaluate Safety and Efficacy of PHX1149T in Subjects With Type 2 Diabetes Mellitus
Official Title
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate Safety and Efficacy of PHX1149T in Subjects With Type 2 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Unknown status
Study Start Date
April 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2008 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Phenomix
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is to test the efficacy and safety of PHX1149T in combination with metformin, a glitazone, or metformin and a glitazone in subjects with Type 2 diabetes for 12 weeks. After completing the 12 week double blind part of the study, subjects can enter an open label extension study
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
PHX1149T
Primary Outcome Measure Information:
Title
HbA1c
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Entry Criteria:
Type 2 diabetes mellitus, diagnosed at least 4 months but not more than 12 years prior to screening.
Male and non-pregnant, non-lactating (and not planning to become pregnant during the study) female subjects with a BMI of 25 to 48 kg/m2, inclusive. For India the BMI is 23 to 48 kg/m2, inclusive.
Current treatment of Type 2 diabetes mellitus with a stable dose of metformin of 1500 mg or more (or the highest tolerated dose), or TZD (any labeled dose), or metformin + TZD at doses used in accordance with product labeling for at least 4 weeks (metformin) or 10 weeks (TZD) prior to screening (Visit 1).
Fasting plasma glucose of 118 - 220 mg/dL (6.6 - 12.2 mmol/L), inclusive; HbA1c 7.3% - 11.0%, inclusive; and a fasting plasma C peptide greater than 0.26 nmol/L at screening. For Argentina the allowed upper limit of HbA1c is ≤ 10.5%. For Canada the upper limit will be 10.0%
No Type 1 diabetes mellitus or marked diabetic long-term complications.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hans-Peter Guler, MD
Organizational Affiliation
Phenomix Corp.
Official's Role
Study Director
Facility Information:
City
Chula Vista
State/Province
California
Country
United States
City
Fullerton
State/Province
California
Country
United States
City
Long Beach
State/Province
California
Country
United States
City
Orange
State/Province
California
Country
United States
City
Kissimmee
State/Province
Florida
Country
United States
City
Melbourne
State/Province
Florida
Country
United States
City
Bloomington
State/Province
Indiana
Country
United States
City
Wichita
State/Province
Kansas
Country
United States
City
Kansas City
State/Province
Missouri
Country
United States
City
Henderson
State/Province
Nevada
Country
United States
City
Las Vegas
State/Province
Nevada
Country
United States
City
Trenton
State/Province
New Jersey
Country
United States
City
Charlotte
State/Province
North Carolina
Country
United States
City
Winston Salem
State/Province
North Carolina
Country
United States
City
Cincinnati
State/Province
Ohio
Country
United States
City
Medford
State/Province
Oregon
Country
United States
City
Westminster
State/Province
Pennsylvania
Country
United States
City
Columbia
State/Province
South Carolina
Country
United States
City
Dallas
State/Province
Texas
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
Salt Lake City
State/Province
Utah
Country
United States
City
Norfolk
State/Province
Virginia
Country
United States
City
Multiple Cities
Country
Argentina
City
Mutiple Cities
Country
Canada
City
Mutiple Cities
Country
India
City
Mutiple Cities
Country
Mexico
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate Safety and Efficacy of PHX1149T in Subjects With Type 2 Diabetes Mellitus
We'll reach out to this number within 24 hrs