Type 2 Diabetes MellitusPhase 3NCT00690638
Safety and Efficacy Study of Dutogliptin/PHX1149T to Treat Type 2 Diabetes Mellitus
A Phase 3 study testing PHX1149T in people with Type 2 Diabetes Mellitus, run by Phenomix at 62 sites in 9 countries.
Trial summary
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate Safety and Efficacy of PHX1149T as Monotherapy in Subjects with Type 2 Diabetes Mellitus 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?
- PHX1149T
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 480 participants
- Where
- 62 sitesin 9 countries
- Study dates
- Jul 2008to Apr 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, drug naïve or willing to wash-out from existing oral therapy
- BMI 25 to 48 kg/m2, inclusive
- HbA1c 7.0% - 10.0%, inclusive
- Age 18 to 75 years, inclusive
Who cannot join
- Currently on 3 or more oral antidiabetic drugs or insulin.
- Type 1 diabetes mellitus
Trial locations and contacts
62 sites in 9 countries.
62 sites in 9 countries
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
Study site
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
Ukraine10 sites
Study site
2A Postysheva Pr., Kharkov
Study site
Ivano-Frankivsk, Ivano-Frankivsk Oblast
Study site
Kharkiv, Kharkiv Oblast
Study site
Kiev, Kyiv City
Study site
Kyiv, Kyiv Oblast
Study site
Lviv, Lviv Oblast
Study site
Poltava, Poltava Oblast
Study site
Simferopol, Crimean Autonomy Republic
Study site
Vinnytsa, Vinnytsa
Study site
Zaporizhzhya, Zaporizhzhia Oblast
India9 sites
Study site
Bangalore, Karnataka
Study site
Chennai, Tamil Nadu
Study site
Hyderabad, Andhara Pradesh
Study site
Kalaburagi, Karnataka
Study site
Mumbai, Maharashtra
Study site
Nagpur, Maharashtra
Study site
Nashik, Maharashtra
Study site
Navi Mumbai, Maharashtra
Study site
Pune, Maharashtra
Argentina7 sites
Study site
Caba, Buenos Aires
Study site
Corrientes
Study site
La Plata, Buenos Aires
Study site
Lanus, Buenos Aires
Study site
Paraná, Entre Ríos Province
Study site
Rosario, Santa Fe Province
Study site
Salta, Salta Province
Romania7 sites
Study site
Brasov, Brașov County
Study site
Galati, Galați County
Study site
Jud. Brasov, Brașov County
Study site
Ploieşti, Ploiesti
Study site
Sector 1, Bucharest
Study site
Sector 2, Bucharest
Study site
Sibiu, Sibiu County
Peru6 sites
Study site
Arequipa, Arequipa
Study site
Chiclayo-Lambayeque, Chiclayo
Study site
Lima Cercado, Lima region
Study site
Lince, Lima region
Study site
San Isisdro, Lima
Study site
San Miguel, Lima region
Malaysia4 sites
Study site
Kelantan
Study site
Kuala Lumpur
Study site
Perak
Study site
Sarawak
Philippines4 sites
Study site
Cebu City, VII
Study site
Manila, NCR
Study site
Quezon City, NCR
Study site
San Juan City, NCR
Thailand2 sites
Study site
Muang, Changwat Khon Kaen
Study site
Ratchatavi, Bangkok
About this study
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate Safety and Efficacy of PHX1149T as Monotherapy in Subjects With Type 2 Diabetes Mellitus
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate Safety and Efficacy of PHX1149T as Monotherapy in Subjects with Type 2 Diabetes Mellitus
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- PHX1149T, Placebo
- Keywords
- dutogliptin, PHX1149, DPP4 inhibitor
- 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
Also called dutogliptin
200 mg
PHX1149TDrug
Also called dutogliptin
400 mg
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Placebo Receives: Drug: Placebo |
| 2 | Experimental | PHX1149T 200 mg Receives: Drug: PHX1149T |
| 3 | Experimental | PHX1149T 400 mg Receives: Drug: PHX1149T |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate changes in HbA1c
Measured: Day 28 to Day 196
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2008 (estimated)
- Study startJul 2008
- Primary completionJan 2010
- Study completionApr 2010
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Phenomix
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Forest Laboratories
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00690638
- Sponsor's protocol ID
- PHX1149-PROT301
- Other IDs
- EudraCT 2008-002614-22
- Status last verified
- Jan 2010
- First submitted
- 2 Jun 2008
- Last updated
- 13 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 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 PHX1149T as Monotherapy in Subjects With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00690638
- Acronym / sponsor ID
- PHX1149-PROT301
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- dutogliptin, PHX1149, DPP4 inhibitor
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- PhenomixIndustry (pharma, biotech, devices)
- Collaborators
- Forest Laboratories
- Study start
- Jul 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 4 Jun 2008 (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.
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate Safety and Efficacy of PHX1149T as Monotherapy in Subjects with Type 2 Diabetes Mellitus
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: PlaceboPlacebo |
| 2 | Experimental | Drug: PHX1149TPHX1149T 200 mg |
| 3 | Experimental | Drug: PHX1149TPHX1149T 400 mg |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Type 2 diabetes mellitus, drug naïve or willing to wash-out from existing oral therapy
- BMI 25 to 48 kg/m2, inclusive
- HbA1c 7.0% - 10.0%, inclusive
- Age 18 to 75 years, inclusive
Key exclusion criteria (2 listed)
- Currently on 3 or more oral antidiabetic drugs or insulin.
- 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 |
|---|---|---|
| PHX1149TAlso: dutogliptin200 mg | Drug | 2 |
| PHX1149TAlso: dutogliptin400 mg | Drug | 3 |
| PlaceboPlacebo | Drug | 1 |
Primary outcome
To demonstrate changes in HbA1c
Time frame: Day 28 to Day 196
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 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.
62 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PHX1149T in people with Type 2 Diabetes Mellitus, run by Phenomix at 62 sites in 9 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 4 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: finished, as of the sponsor's last update on 13 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 62 sites in United States, Ukraine, India, Argentina, Romania and 4 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 changes in HbA1c (time frame: Day 28 to Day 196). 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 13 Apr 2010.