NCT00482950

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

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for phase_2 type-2-diabetes-mellitus

Timeline
Completed

Started Apr 2007

Shorter than P25 for phase_2 type-2-diabetes-mellitus

Geographic Reach
5 countries

26 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 4, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 6, 2007

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

June 8, 2009

Status Verified

June 1, 2009

First QC Date

June 4, 2007

Last Update Submit

June 4, 2009

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    12 weeks

Interventions

PHX1149TDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (26)

Unknown Facility

Chula Vista, California, United States

Location

Unknown Facility

Fullerton, California, United States

Location

Unknown Facility

Long Beach, California, United States

Location

Unknown Facility

Orange, California, United States

Location

Unknown Facility

Kissimmee, Florida, United States

Location

Unknown Facility

Melbourne, Florida, United States

Location

Unknown Facility

Bloomington, Indiana, United States

Location

Unknown Facility

Wichita, Kansas, United States

Location

Unknown Facility

Kansas City, Missouri, United States

Location

Unknown Facility

Henderson, Nevada, United States

Location

Unknown Facility

Las Vegas, Nevada, United States

Location

Unknown Facility

Trenton, New Jersey, United States

Location

Unknown Facility

Charlotte, North Carolina, United States

Location

Unknown Facility

Winston-Salem, North Carolina, United States

Location

Unknown Facility

Cincinnati, Ohio, United States

Location

Unknown Facility

Medford, Oregon, United States

Location

Unknown Facility

Westminster, Pennsylvania, United States

Location

Unknown Facility

Columbia, South Carolina, United States

Location

Unknown Facility

Dallas, Texas, United States

Location

Unknown Facility

San Antonio, Texas, United States

Location

Unknown Facility

Salt Lake City, Utah, United States

Location

Unknown Facility

Norfolk, Virginia, United States

Location

Unknown Facility

Multiple Cities, Argentina

Location

Unknown Facility

Mutiple Cities, Canada

Location

Unknown Facility

Mutiple Cities, India

Location

Unknown Facility

Mutiple Cities, Mexico

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Hans-Peter Guler, MD

    Phenomix Corp.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Expanded Access
Yes

Study Record Dates

First Submitted

June 4, 2007

First Posted

June 6, 2007

Study Start

April 1, 2007

Study Completion

February 1, 2008

Last Updated

June 8, 2009

Record last verified: 2009-06

Locations

AR(1)US(22)IN(1)ME(1)CA(1)