Type 2 Diabetes MellitusPhase 3NCT00998686
Safety and Efficacy Study of Dutogliptin in Subjects With Type 2 Diabetes Mellitus on a Background Medication of Metformin
A Phase 3 study testing dutogliptin and sitagliptin in people with Type 2 Diabetes Mellitus, run by Phenomix at 44 sites in 6 countries.
Trial summary
The purpose of this study is to demonstrate the safety and tolerability of dutogliptin over 52 weeks. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- dutogliptin and sitagliptin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 650 participants
- Where
- 44 sitesin 6 countries
- Study dates
- Nov 2009to Nov 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
- Current treatment of Type 2 diabetes mellitus as in PHX1149-PROT302
Who cannot join
- 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
44 sites in 6 countries.
44 sites in 6 countries
United States23 sites
Phenomix Investigational Site 116
Albuquerque, New Mexico
Phenomix Investigational Site 105
Anaheim, California
Phenomix Investigational Site 138
Biloxi, Mississippi
Phenomix Investigational Site 136
Brockton, Massachusetts
Phenomix Investigational Site 135
Chicago, Illinois
Phenomix Investigational Site 143
Coral Gables, Florida
Phenomix Investigational Site 102
Dallas, Texas
Phenomix Investigational Site 112
Greenville, South Carolina
Phenomix Investigational Site 142
Hialeah, Florida
Phenomix Investigational Site 101
Honolulu, Hawaii
Phenomix Investigational Site 124
Indianapolis, Indiana
Phenomix Investigational Site 100
Kenosha, Wisconsin
Phenomix Investigational Site 133
Kissimmee, Florida
Phenomix Investigational Site 122
Las Vegas, Nevada
Phenomix Investigational Site 140
Las Vegas, Nevada
Phenomix Investigational Site 103
Long Beach, California
Phenomix Investigational Site 106
Los Angeles, California
Phenomix Investigational Site 105
Montgomery, Alabama
Phenomix Investigational Site 104
San Antonio, Texas
Phenomix Investigational Site 121
Tempe, Arizona
Phenomix Investigational Site 137
Tempe, Arizona
Phenomix Investigational Site 110
Trenton, New Jersey
Phenomix Investigational Site 107
Winston-Salem, North Carolina
Poland6 sites
Phenomix Investigational Site 300
Gdansk
Phenomix Investigational Site 309
Karkow
Phenomix Investigational Site 303
Katowice
Phenomix Investigational Site 306
Puławy
Phenomix Investigational Site 305
Warsaw
Phenomix Investigational Site 302
Wroclaw
India5 sites
Phenomix Investigational Site 701
Bangalore, Karnataka
Phenomix Investigational Site 706
Indore, Madhya Pradesh
Phenomix Investigational Site 711
Mumbai, Maharashtra
Phenomix Investigational Site 707
Shāstrinagar, Jaipur
Phenomix Investigational Site 705
Trivandrum, Kerala
Peru4 sites
Phenomix Investigational Site 607
Arequipa
Phenomix Investigational Site 601
Ica
Phenomix Investigational Site 604
Lima
Phenomix Investigational Site 610
Lima
Argentina3 sites
Phenomix Investigational Site 402
Buenos Aires
Phenomix Investigational Site 408
Buenos Aires
Phenomix Investigational Site 410
Mendoza
Czechia3 sites
Phenomix Investigational Site 208
Prague
Phenomix Investigational Site 209
Praha 4 Chodov
Phenomix Investigational Site 207
Uničov
About this study
Official title: A Phase 3, Randomized, Double-Blind, Active-Controlled, Multi-Center Extension Study to Evaluate Safety and Efficacy of Dutogliptin in Subjects With Type 2 Diabetes Mellitus on a Background Medication of Metformin
The purpose of this study is to demonstrate the safety and tolerability of dutogliptin over 52 weeks.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- dutogliptin, sitagliptin
- Keywords
- diabetes, DPP4 inhibitor, dutogliptin
- 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
sitagliptinDrug
100 mg
| Study group | Role | What they receive |
|---|---|---|
| dutogliptin/PHX1149T | Experimental | Not described Receives: Drug: dutogliptin |
| sitagliptin | Active comparator | Not described Receives: Drug: sitagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate safety and tolerability of dutogliptin as assessed by vital signs, adverse event reporting, routine clinical laboratory assessments, and ECG
Measured: 52 weeks
Secondary outcomes (1)
To demonstrate maintenance or lowering of HbA1c and fasting plasma glucose
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2009 (estimated)
- Study startNov 2009
- Primary completionOct 2011 (estimated)
- Study completionNov 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Phenomix
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Forest Laboratories
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00998686
- Sponsor's protocol ID
- PHX1149-PROT402
- Status last verified
- Aug 2010
- First submitted
- 16 Oct 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
- A Phase 3, Randomized, Double-Blind, Active-Controlled, Multi-Center Extension Study to Evaluate Safety and Efficacy of Dutogliptin in Subjects With Type 2 Diabetes Mellitus on a Background Medication of Metformin
- ClinicalTrials.gov ID
- NCT00998686
- Acronym / sponsor ID
- PHX1149-PROT402
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- diabetes, DPP4 inhibitor, dutogliptin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- PhenomixIndustry (pharma, biotech, devices)
- Collaborators
- Forest Laboratories
- Study start
- Nov 2009
- Primary completion
- Oct 2011 (estimated)
- Study completion
- Nov 2011 (estimated)
- First posted
- 20 Oct 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 the safety and tolerability of dutogliptin over 52 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dutogliptin/PHX1149T | Experimental | Drug: dutogliptin |
| sitagliptin | Active comparator | Drug: sitagliptin |
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
- Current treatment of Type 2 diabetes mellitus as in PHX1149-PROT302
Key exclusion criteria (1 listed)
- 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 |
|---|---|---|
| dutogliptin400 mg | Drug | dutogliptin/PHX1149T |
| sitagliptin100 mg | Drug | sitagliptin |
Primary outcome
To demonstrate safety and tolerability of dutogliptin as assessed by vital signs, adverse event reporting, routine clinical laboratory assessments, and ECG
Time frame: 52 weeks
1 secondary outcome
To demonstrate maintenance or lowering of HbA1c and fasting plasma glucose
Time frame: 52 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.
44 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing dutogliptin and sitagliptin in people with Type 2 Diabetes Mellitus, run by Phenomix at 44 sites in 6 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 44 sites in United States, Poland, India, Peru, Argentina and 1 more country. 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 as assessed by vital signs, adverse event reporting, routine clinical laboratory assessments, and ECG (time frame: 52 weeks). 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.