Type 2 Diabetes MellitusPhase 3NCT00850239
Safety and Efficacy Study of Dutogliptin/PHX1149T in Subjects With Type 2 Diabetes Mellitus on a Background Medication of Metformin
A Phase 3 study testing dutogliptin in people with Type 2 Diabetes Mellitus, run by Phenomix at 97 sites in 7 countries.
Trial summary
The purpose of this study is to demonstrate the efficacy of dutogliptin over 26 weeks (as evidenced by placebo-corrected changes in HbA1c relative to baseline), to demonstrate safety and tolerability of dutogliptin, and to demonstrate changes in fasting plasma glucose over 26 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
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 700 participants
- Where
- 97 sitesin 7 countries
- Study dates
- May 2009to Dec 2010
- 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
- Type 2 diabetes mellitus, diagnosed at least 4 months prior to Screening (Visit 1)
- Age 18 to 85 years, inclusive.
- Male and non-pregnant, non-lactating (and not planning to become pregnant during the study) female subjects with a BMI of 20 to 48 kg/m2, inclusive
- Current treatment of Type 2 diabetes mellitus with a stable dose of metformin of ≥ 2000 mg (or the highest tolerated dose) used in accordance with product labeling for at least 6 weeks prior to screening (Visit 1)
- HbA1c 7.0% - 10.0%, inclusive; and fasting plasma C peptide greater than 0.26 nmol/L (> 0.8 ng/mL; > 281 pmol/L) at screening (Visit 1)
Who cannot join
- Type 1 diabetes mellitus
Trial locations and contacts
97 sites in 7 countries.
97 sites in 7 countries
United States34 sites
Phenomix Investigational Site 116
Albuquerque, New Mexico
Phenomix Investigational Site 105
Anaheim, California
Phenomix Investigational Site 138
Biloxi, Mississippi
Phenomix Investigational Site 131
Brick, New Jersey
Phenomix Investigational Site 136
Brockton, Massachusetts
Phenomix Investigational Site 135
Chicago, Illinois
Phenomix Investigational Site 123
Chico, California
Phenomix Investigational Site 130
Cincinnati, Ohio
Phenomix Investigational Site 143
Coral Gables, Florida
Phenomix Investigational Site 118
Cuyahoga Falls, Ohio
Phenomix Investigational Site 102
Dallas, Texas
Phenomix Investigational Site 139
Dallas, Texas
Phenomix Investigational Site 141
Dunwoody, Georgia
Phenomix Investigational Site 126
El Paso, Texas
Phenomix Investigational Site 134
Escondido, California
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 127
Indianapolis, Indiana
Phenomix Investigational Site 119
Jacksonville, Florida
Phenomix Investigational Site 125
Kalamazoo, Michigan
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 115
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
Poland14 sites
Phenomix Investigational Site 300
Gdansk
Phenomix Investigational Site 301
Gdansk
Phenomix Investigational Site 303
Katowice
Phenomix Investigational Site 312
Katowice
Phenomix Investigational Site 309
Krakow
Phenomix Investigational Site 313
Krakow
Phenomix Investigational Site 308
Lublin
Phenomix Investigational Site 310
Poznan
Phenomix Investigational Site 306
Puławy
Phenomix Investigational Site 304
Szczecin
Phenomix Investigational Site 305
Warsaw
Phenomix Investigational Site 307
Warsaw
Phenomix Investigational Site 311
Warsaw
Phenomix Investigational Site 302
Wroclaw
Argentina12 sites
Phenomix Investigational Site 401
Buenos Aires
Phenomix Investigational Site 402
Buenos Aires
Phenomix Investigational Site 404
Buenos Aires
Phenomix Investigational Site 405
Buenos Aires
Phenomix Investigational Site 406
Buenos Aires
Phenomix Investigational Site 407
Buenos Aires
Phenomix Investigational Site 408
Buenos Aires
Phenomix Investigational Site 409
Buenos Aires
Phenomix Investigational Site 411
Buenos Aires
Phenomix Investigational Site 403
Corrientes
Phenomix Investigational Site 410
Mendoza
Phenomix Investigational Site 400
Rosario
India12 sites
Phenomix Investigational Site 701
Bangalore, Karnataka
Phenomix Investigational Site 702
Bangalore, Karnataka
Phenomix Investigational Site 708
Chennai
Phenomix Investigational Site 709
Gopālapuram, Chennai
Phenomix Investigational Site 703
Hyderabad, Andhara Pradesh
Phenomix Investigational Site 706
Indore, Madhya Pradesh
Phenomix Investigational Site 711
Mumbai, Maharashtra
Phenomix Investigational Site 700
Nashik, Maharashtra
Phenomix Investigational Site 710
Navi Mumbai, Maharashtra
Phenomix Investigational Site 707
Shāstrinagar, Jaipur
Phenomix Investigational Site 705
Trivandrum, Kerala
Phenomix Investigational Site 704
Visakhapatanam, Andhra Pradesh
Peru11 sites
Phenomix Investigational Site 607
Arequipa
Phenomix Investigational Site 601
Ica
Phenomix Investigational Site 600
Lima
Phenomix Investigational Site 603
Lima
Phenomix Investigational Site 604
Lima
Phenomix Investigational Site 608
Lima
Phenomix Investigational Site 610
Lima
Phenomix Investigational Site 605
Lima Cercado
Phenomix Investigational Site 606
Piura
Phenomix Investigational Site 602
Trujillo
Phenomix Investigational Site 609
Wanchaq Cusco
Czechia9 sites
Phenomix Investigational Site 209
Chodov
Phenomix Investigational Site 205
Havířov-Město
Phenomix Investigational Site 204
Liberec
Phenomix Investigational Site 202
Olomouc
Phenomix Investigational Site 206
Ostrava-Kunčice
Phenomix Investigational Site 208
Prague
Phenomix Investigational Site 203
Prostějov
Phenomix Investigational Site 207
Uničov
Phenomix Investigational Site 201
Valašské Klobouky
Chile5 sites
Phenomix Investigational Site 502
Santiago
Phenomix Investigational Site 504
Santiago
Phenomix Investigational Site 505
Santiago
Phenomix Investigational Site 500
Temuco
Phenomix Investigational Site 501
Temuco
About this study
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate Safety and Efficacy of Dutogliptin/PHX1149T in Subjects With Type 2 Diabetes Mellitus on a Background Medication of Metformin
The purpose of this study is to demonstrate the efficacy of dutogliptin over 26 weeks (as evidenced by placebo-corrected changes in HbA1c relative to baseline), to demonstrate safety and tolerability of dutogliptin, and to demonstrate changes in fasting plasma glucose over 26 weeks.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- dutogliptin, placebo
- 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
Also called PHX1149T
400 mg
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | dutogliptin/PHX1149T Receives: Drug: dutogliptin |
| 2 | Placebo comparator | Plabeco Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary objective is to demonstrate the efficacy of dutogliptin, as evidenced by placebo-corrected changes in HbA1c relative to baseline.
Measured: 26 weeks
Secondary outcomes (2)
Demonstrate safety and tolerability of dutogliptin
Measured: 26 weeks
• Demonstrate changes in fasting plasma glucose
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2009 (estimated)
- Study startMay 2009
- Primary completionOct 2010 (estimated)
- Study completionDec 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Phenomix
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Forest Laboratories
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00850239
- Sponsor's protocol ID
- PHX1149-PROT302
- Status last verified
- Aug 2010
- First submitted
- 20 Feb 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, Placebo-Controlled, Multi-Center Study to Evaluate Safety and Efficacy of Dutogliptin/PHX1149T in Subjects With Type 2 Diabetes Mellitus on a Background Medication of Metformin
- ClinicalTrials.gov ID
- NCT00850239
- Acronym / sponsor ID
- PHX1149-PROT302
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- diabetes, DPP4 inhibitor, dutogliptin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- PhenomixIndustry (pharma, biotech, devices)
- Collaborators
- Forest Laboratories
- Study start
- May 2009
- Primary completion
- Oct 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 24 Feb 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 efficacy of dutogliptin over 26 weeks (as evidenced by placebo-corrected changes in HbA1c relative to baseline), to demonstrate safety and tolerability of dutogliptin, and to demonstrate changes in fasting plasma glucose over 26 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: dutogliptindutogliptin/PHX1149T |
| 2 | Placebo comparator | Drug: placeboPlabeco |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Type 2 diabetes mellitus, diagnosed at least 4 months prior to Screening (Visit 1)
- Age 18 to 85 years, inclusive.
- Male and non-pregnant, non-lactating (and not planning to become pregnant during the study) female subjects with a BMI of 20 to 48 kg/m2, inclusive
- Current treatment of Type 2 diabetes mellitus with a stable dose of metformin of ≥ 2000 mg (or the highest tolerated dose) used in accordance with product labeling for at least 6 weeks prior to screening (Visit 1)
- HbA1c 7.0% - 10.0%, inclusive; and fasting plasma C peptide greater than 0.26 nmol/L (> 0.8 ng/mL; > 281 pmol/L) at screening (Visit 1)
Key exclusion criteria (1 listed)
- Type 1 diabetes mellitus
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: PHX1149T400 mg | Drug | 1 |
| placebo | Drug | 2 |
Primary outcome
Primary objective is to demonstrate the efficacy of dutogliptin, as evidenced by placebo-corrected changes in HbA1c relative to baseline.
Time frame: 26 weeks
2 secondary outcomes
Demonstrate safety and tolerability of dutogliptin
Time frame: 26 weeks
• Demonstrate changes in fasting plasma glucose
Time frame: 26 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.
97 sites in 7 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, run by Phenomix at 97 sites in 7 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 5 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 97 sites in United States, Poland, Argentina, India, Peru and 2 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. Some participants in this study may receive a placebo. 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?
Primary objective is to demonstrate the efficacy of dutogliptin, as evidenced by placebo-corrected changes in HbA1c relative to baseline. (time frame: 26 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; AzTrials last refreshed its copy on 8 Nov 2026.