Type 2 Diabetes MellitusPhase 3NCT00865592
Long-term Study to Evaluate the Safety of Dutogliptin/PHX1149T in Subjects With Type 2 Diabetes Mellitus
A Phase 3 study testing dutogliptin in people with Type 2 Diabetes Mellitus and Type 2 Diabetes, run by Phenomix at 68 sites in 8 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 85 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Type 2 Diabetes
- What is being tested?
- dutogliptin
- Type of treatment
- Pill or oral medicine
- How many people
- 450 participants
- Where
- 68 sitesin 8 countries
- Study dates
- Mar 2009to Mar 2011
- Phase
- Phase 3
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Completion of all required visits of a qualifying Phase 3 core protocol (e.g., Visit 8/Day 196 of PHX1149-PROT301)
- Current treatment of Type 2 diabetes mellitus as in PHX1149-PROT301
Who cannot join
- Except for Type 2 diabetes, any other uncontrolled, serious pulmonary, cardiovascular, hematologic, renal, gastrointestinal, endocrine, neurological, proliferative, immunosuppressive, psychiatric, or urogenital disorder; or diseases of skin and its appendages, the eyes, ears, nose, or throat
- Any condition, disease, disorder or clinically relevant laboratory abnormality which, in the opinion of the investigator, would jeopardize the patient's appropriate participation in this study or obscure the effects of treatment
Trial locations and contacts
68 sites in 8 countries.
68 sites in 8 countries
Ukraine15 sites
Phenomix Investigational Site 551
Ivano-Frankivsk
Phenomix Investigational Site 550
Kharkiv
Phenomix Investigational Site 557
Kharkiv
Phenomix Investigational Site 564
Kharkiv
Phenomix Investigational Site 555
Kiev
Phenomix Investigational Site 556
Kiev
Phenomix Investigational Site 562
Kiev
Phenomix Investigational Site 563
Kiev
Phenomix Investigational Site 554
Kylv
Phenomix Investigational Site 565
Lutsk
Phenomix Investigational Site 553
Lviv
Phenomix Investigational Site 561
Poltava
Phenomix Investigational Site 560
Simferopol
Phenomix Investigational Site 559
Vinnitsa
Phenomix Investigational Site 552
Zaporzhzhia
United States13 sites
Study site
Atlanta, Georgia
Study site
Brockton, Massachusetts
Study site
Cincinnati, Ohio
Study site
Daytona Beach, Florida
Study site
El Paso, Texas
Phenomix Investigational Site 663
Honolulu, Hawaii
Study site
Kissimmee, Florida
Study site
Norfolk, Virginia
Study site
Norwalk, California
Study site
Orange, California
Study site
San Antonio, Texas
Study site
Santa Ana, California
Study site
St Louis, Missouri
India9 sites
Study site
Bangalore, Karnataka
Study site
Chennai, Tamil Nadu
Study site
Gulbarga, Karnataka
Study site
Hyderabad, Andhara Pradesh
Study site
Mumbai, Maharashtra
Study site
Nagpur, Maharashtra
Study site
Nashik, Maharashtra
Study site
Navi Mumbai, Maharashtra
Study site
Pune, Maharashtra
Romania9 sites
Phenomix Investigational Site 802
Brasov
Phenomix Investigational Site 806
Brasov
Phenomix Investigational Site 800
Bucharest
Phenomix Investigational Site 803
Bucharest
Phenomix Investigational Site 805
Bucharest
Phenomix Investigational Site 807
Bucharest
Phenomix Investigational Site 804
Galati
Phenomix Investigational Site 801
Ploieşti
Phenomix Investigational Site 808
Sibiu
Argentina6 sites
Phenomix Investigational Site 103
Buenos Aires
Phenomix Investigational Site 110
Buenos Aires
Phenomix Investigational Site 111
Buenos Aires
Phenomix Investigational Site 106
Caba
Phenomix Investigational Site 112
Corrientes
Phenomix Investigational Site 102
Paraná
Malaysia6 sites
Study site
Kelantan
Study site
Kuala Lumpur
Phenomix Investigational Site 403
Kuching, Sarawak
Study site
Perak
Phenomix Investigational Site 404
Putrajaya
Study site
Sarawak
Peru6 sites
Phenomix Investigational Site 604
Arequipa
Phenomix Investigational Site 606
Lambayeque
Phenomix Investigational Site 600
Lima
Phenomix Investigational Site 601
Lima
Phenomix Investigational Site 602
Lima
Phenomix Investigational Site 609
Lima
Philippines4 sites
Phenomix Investigational Site 703
Cebu City
Study site
Manila, NCR
Study site
Quezon City, NCR
Study site
San Juan, NCR
About this study
Official title: An Open Label, Multi-Center, Long-Term Extension Study to Evaluate the Safety of PHX1149T/Dutogliptin in Subjects With Type 2 Diabetes Mellitus
The purpose of this study is to demonstrate that dutogliptin/PHX1149T is safe and tolerable.
Read the detailed description
In this study, open-label dutogliptin/PHX1149T will be offered to subjects who complete a Phase 3 core protocol and wish to continue treatment with dutogliptin. This will allow for the collection of long-term safety data and will also demonstrate long-term effects on HbA1c and fasting blood glucose.
- Conditions
- Type 2 Diabetes Mellitus, Type 2 Diabetes
- 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
Also called PHX1149T, PHX1149, dutogliptin tartrate
dutogliptin 400 mg, once daily tablet
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate safety and tolerability of dutogliptin
Measured: Two years
Secondary outcomes (2)
To demonstrate maintenance or lowering of HbA1c
Measured: Two years
To demonstrate maintenance or lowering of fasting blood glucose
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionJan 2011 (estimated)
- Study completionMar 2011 (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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Phenomix
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Forest Laboratories
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00865592
- Sponsor's protocol ID
- PHX1149-PROT300E
- Status last verified
- Aug 2010
- First submitted
- 17 Mar 2009
- Last updated
- 11 Aug 2010
- Results posted
- No
- Data monitoring committee
- 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 Extension Study to Evaluate the Safety of PHX1149T/Dutogliptin in Subjects With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00865592
- Acronym / sponsor ID
- PHX1149-PROT300E
- Conditions
- Type 2 Diabetes Mellitus, Type 2 Diabetes
- Keywords
- diabetes, DPP4 inhibitor, dutogliptin, PHX1149
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- PhenomixIndustry (pharma, biotech, devices)
- Collaborators
- Forest Laboratories
- Study start
- Mar 2009
- Primary completion
- Jan 2011 (estimated)
- Study completion
- Mar 2011 (estimated)
- First posted
- 19 Mar 2009 (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.
Detailed description
In this study, open-label dutogliptin/PHX1149T will be offered to subjects who complete a Phase 3 core protocol and wish to continue treatment with dutogliptin. This will allow for the collection of long-term safety data and will also demonstrate long-term effects on HbA1c and fasting blood glucose.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Completion of all required visits of a qualifying Phase 3 core protocol (e.g., Visit 8/Day 196 of PHX1149-PROT301)
- Current treatment of Type 2 diabetes mellitus as in PHX1149-PROT301
Key exclusion criteria (2 listed)
- Except for Type 2 diabetes, any other uncontrolled, serious pulmonary, cardiovascular, hematologic, renal, gastrointestinal, endocrine, neurological, proliferative, immunosuppressive, psychiatric, or urogenital disorder; or diseases of skin and its appendages, the eyes, ears, nose, or throat
- Any condition, disease, disorder or clinically relevant laboratory abnormality which, in the opinion of the investigator, would jeopardize the patient's appropriate participation in this study or obscure the effects of treatment
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 |
|---|---|---|
| dutogliptinAlso: PHX1149T, PHX1149, dutogliptin tartratedutogliptin 400 mg, once daily tablet | Drug | – |
Primary outcome
To demonstrate safety and tolerability of dutogliptin
Time frame: Two years
2 secondary outcomes
To demonstrate maintenance or lowering of HbA1c
Time frame: Two years
To demonstrate maintenance or lowering of fasting blood glucose
Time frame: Two years
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.
68 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing dutogliptin in people with Type 2 Diabetes Mellitus and Type 2 Diabetes, run by Phenomix at 68 sites in 8 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 2 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 68 sites in Ukraine, United States, India, Romania, Argentina and 3 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 (time frame: Two years). 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.