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Type 2 Diabetes MellitusPhase 2NCT00482950

A Study to Evaluate Safety and Efficacy of PHX1149T in Subjects With Type 2 Diabetes Mellitus

A Phase 2 study testing PHX1149T in people with Type 2 Diabetes Mellitus, run by Phenomix at 26 sites in 5 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
PHX1149T
How many people
400 participants
Where
26 sitesin 5 countries
Study dates
Apr 2007to Feb 2008
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Trial locations and contacts

26 sites in 5 countries.

26 sites in 5 countries

United States22 sites

  • Study site

    Bloomington, Indiana

  • Study site

    Charlotte, North Carolina

  • Study site

    Chula Vista, California

  • Study site

    Cincinnati, Ohio

  • Study site

    Columbia, South Carolina

  • Study site

    Dallas, Texas

  • Study site

    Fullerton, California

  • Study site

    Henderson, Nevada

  • Study site

    Kansas City, Missouri

  • Study site

    Kissimmee, Florida

  • Study site

    Las Vegas, Nevada

  • Study site

    Long Beach, California

  • Study site

    Medford, Oregon

  • Study site

    Melbourne, Florida

  • Study site

    Norfolk, Virginia

  • Study site

    Orange, California

  • Study site

    Salt Lake City, Utah

  • Study site

    San Antonio, Texas

  • Study site

    Trenton, New Jersey

  • Study site

    Westminster, Pennsylvania

  • Study site

    Wichita, Kansas

  • Study site

    Winston-Salem, North Carolina

Other trials in United States

Argentina1 site

  • Study site

    Multiple Cities

Other trials in Argentina

Canada1 site

  • Study site

    Mutiple Cities

Other trials in Canada

India1 site

  • Study site

    Mutiple Cities

Other trials in India

Mexico1 site

  • Study site

    Mutiple Cities

Other trials in Mexico

About this study

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

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

Being tested
PHX1149T
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PHX1149TDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HbA1c

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2007 (estimated)
  2. Study startApr 2007
  3. Study completionFeb 2008 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00482950
Sponsor's protocol ID
PHX1149-Prot202
Status last verified
Jun 2009
First submitted
4 Jun 2007
Last updated
8 Jun 2009
Results posted
No
Data monitoring committee
No
Expanded access
Available

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PHX1149T in people with Type 2 Diabetes Mellitus, run by Phenomix at 26 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in United States, Argentina, Canada, India, Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HbA1c (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00482950.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2009.

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