Type 2 Diabetes MellitusPhase 2NCT01101945
Long-term Extension Study to Evaluate the Safety of Dutogliptin/PHX1149T in Subjects With Type 2 Diabetes Mellitus
A Phase 2 study testing dutogliptin in people with Type 2 Diabetes Mellitus, run by Phenomix at 55 sites in 5 countries.
Trial summary
The purpose of this study is to demonstrate that dutogliptin/PHX1149T is safe and tolerable. 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?
- dutogliptin
- How many people
- 339 participants
- Where
- 55 sitesin 5 countries
- Study dates
- Jul 2007to Mar 2010
- 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
Who may be able to join
- Completed Visit 7/Day 98 of the core protocol PHX1149-PROT202
- Current treatment of Type 2 diabetes mellitus in accordance with product labeling with metformin, or thiazolidinedione (TZD), or metformin + TZD
Who cannot join
- Inadequately controlled Type 2 diabetes mellitus with need for therapy with insulin
Trial locations and contacts
55 sites in 5 countries.
55 sites in 5 countries
United States27 sites
Study site
Berlin, New Jersey
Study site
Charlotte, North Carolina
Study site
Cincinnati, Ohio
Study site
Columbia, South Carolina
Study site
Dallas, Texas
Study site
Fullerton, California
Study site
Greer, South Carolina
Study site
Gurnee, Illinois
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
Margate City, New Jersey
Study site
Medford, Oregon
Study site
Melbourne, Florida
Study site
New Port Richey, Florida
Study site
Norfolk, Virginia
Study site
Oklahoma City, Oklahoma
Study site
Orange, California
Study site
Salt Lake City, Utah
Study site
San Antonio, Texas
Study site
San Diego, California
Study site
Trenton, New Jersey
Study site
Warminster, Pennsylvania
Study site
Wichita, Kansas
Study site
Winston-Salem, North Carolina
Canada11 sites
Study site
Calgary, Alberta
Study site
Cornwall, Prince Edward Island
Study site
Etobicoke, Ontario
Study site
London, Ontario
Study site
Mirabel, Quebec
Study site
Montreal, Quebec
Study site
Mount Pearl, Newfoundland and Labrador
Study site
Red Deer, Alberta
Study site
Samia, Ontario
Study site
St. John's, Newfoundland and Labrador
Study site
Toronto, Ontario
India7 sites
Study site
Banjara Hills, Hyderabad
Study site
Chennai, Tamil Nadu
Study site
Dhantoli, Nagpur
Study site
Ellisbridge, Ahmedabad
Study site
Pune, Maharashtra
Study site
Punjagutta, Hyderabad
Study site
Tardeo, Mumbai
Argentina6 sites
Study site
Corrientes, Corrientes Province
Study site
Cuidad Autonoma de Buenos Aires, Buenos Aires
Study site
La Plata, Buenos Aires
Study site
Lanús Este, Buenos Aires
Study site
Morón, Buenos Aires
Study site
Quilmes, Buenos Aires
Mexico4 sites
Study site
Guadalajara, Jalisco
Study site
Mexico City, Mexico City
Study site
Monterrey N. L., Nuevo León
Study site
Morelia, Michoacán
About this study
Official title: An Open Label, Multi-Center, Long-Term Follow-up Study to Evaluate the Safety of PHX1149T in Subjects With Type 2 Diabetes Mellitus - Extension to Protocol PHX1149-PROT202
The purpose of this study is to demonstrate that dutogliptin/PHX1149T is safe and tolerable.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- dutogliptin
- Keywords
- diabetes, DPP4 inhibitor, dutogliptin, PHX1149
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dutogliptinDrug
400 mg QD
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate safety and tolerability of dutogliptin/PHX1149T as assessed by vital signs, adverse event reporting, and routine clinical laboratory assessments
Measured: 104 weeks
To demonstrate safety and tolerability of dutogliptin/PHX1149Tas assessed by vital signs, adverse event reporting, and routine clinical laboratory assessments
Measured: 208 weeks (U.S. only)
Secondary outcomes (1)
To demonstrate maintenance or lowering of HbA1c and fasting blood glucose
Measured: 104 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2010 (estimated)
- Study startJul 2007
- Primary completionJan 2010 (estimated)
- Study completionMar 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 339 participants (actual)
Sponsor and investigators
- Lead sponsor
- Phenomix
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01101945
- Sponsor's protocol ID
- PHX1149-PROT202E
- Status last verified
- Aug 2010
- First submitted
- 8 Apr 2010
- Last updated
- 11 Aug 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Multi-Center, Long-Term Follow-up Study to Evaluate the Safety of PHX1149T in Subjects With Type 2 Diabetes Mellitus - Extension to Protocol PHX1149-PROT202
- ClinicalTrials.gov ID
- NCT01101945
- Acronym / sponsor ID
- PHX1149-PROT202E
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- diabetes, DPP4 inhibitor, dutogliptin, PHX1149
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 339 participants (actual)
- Lead sponsor
- PhenomixIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Jan 2010 (estimated)
- Study completion
- Mar 2010 (estimated)
- First posted
- 12 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to demonstrate that dutogliptin/PHX1149T is safe and tolerable.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Completed Visit 7/Day 98 of the core protocol PHX1149-PROT202
- Current treatment of Type 2 diabetes mellitus in accordance with product labeling with metformin, or thiazolidinedione (TZD), or metformin + TZD
Key exclusion criteria (1 listed)
- Inadequately controlled Type 2 diabetes mellitus with need for therapy with insulin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dutogliptin400 mg QD | Drug | – |
Primary outcome
To demonstrate safety and tolerability of dutogliptin/PHX1149T as assessed by vital signs, adverse event reporting, and routine clinical laboratory assessments
Time frame: 104 weeks
To demonstrate safety and tolerability of dutogliptin/PHX1149Tas assessed by vital signs, adverse event reporting, and routine clinical laboratory assessments
Time frame: 208 weeks (U.S. only)
1 secondary outcome
To demonstrate maintenance or lowering of HbA1c and fasting blood glucose
Time frame: 104 weeks
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
55 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing dutogliptin in people with Type 2 Diabetes Mellitus, run by Phenomix at 55 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?
The sponsor lists 2 inclusion and 1 exclusion criteria. 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: stopped early, as of the sponsor's last update on 11 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 55 sites in United States, Canada, India, Argentina, 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?
The study was stopped early. 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?
To demonstrate safety and tolerability of dutogliptin/PHX1149T as assessed by vital signs, adverse event reporting, and routine clinical laboratory assessments (time frame: 104 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Aug 2010.