Diabetes Mellitus Type 2Phase 2NCT00388518
A Study of Aleglitazar in Patients With Type 2 Diabetes
A Phase 2 study testing Actos and aleglitazar in people with Diabetes Mellitus Type 2, run by Hoffmann-La Roche at 55 sites in 8 countries.
Trial summary
This 6 arm study will assess the efficacy, safety, tolerability and pharmacokinetics of aleglitazar therapy in patients with Type 2 diabetes. Patients will be randomised to one of 6 treatment arms, to receive one of 4 doses of aleglitazar, Actos as an open-label active comparator, or placebo. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus Type 2
- What is being tested?
- Actos and aleglitazar
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 332 participants
- Where
- 55 sitesin 8 countries
- Study dates
- Nov 2006to Mar 2008
- 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
- adult patients, 18-75 years of age;
- type 2 diabetes, diagnosed >=1 month of screening;
- either drug-naive, or pretreated with a maximum of 2 oral antihyperglycemic agents at submaximal doses;
- HbA1c <=10.0% at screening, and 7.0-10.0% at pre-randomisation visit.
Who cannot join
- type 1 diabetes;
- currently or previously treated with insulin, a thiazolidinedione, or a dual Peroxisome Proliferator Activated Receptor (PPAR) agonist;
- clinically significant cardiovascular disease;
- Congestive Heart Failure (CHF) New York Heart Association (NYHA) 3-4.
Trial locations and contacts
55 sites in 8 countries.
55 sites in 8 countries
United States18 sites
Study site
Augusta, Georgia, 30909
Study site
Baltimore, Maryland, 21229
Study site
Baton Rouge, Louisiana, 70809
Study site
Beverly Hills, California, 90211
Study site
Chicago, Illinois, 60611
Study site
Chiefland, Florida, 32626
Study site
Hamilton, New Jersey, 08610
Study site
Hollywood, Florida, 33023
Study site
Idaho Falls, Idaho, 83404
Study site
Johnson City, Tennessee, 37604
Study site
New Hyde Park, New York, 11042
Study site
Olive Branch, Mississippi, 38654
Study site
Palm Springs, California, 92262
Study site
Phoenix, Arizona, 85006
Study site
Phoenix, Arizona, 85029
Study site
San Diego, California, 92161
Study site
Spokane, Washington, 99216
Study site
West Palm Beach, Florida, 33401
Italy9 sites
Study site
Bologna, 40138
Study site
Genova, 16132
Study site
Naples, 80100
Study site
Olbia, 07026
Study site
Pavia, 27100
Study site
Perugia, 06126
Study site
Roma, 00133
Study site
Siena, 53100
Study site
Torino, 10126
Mexico9 sites
Study site
Aguascalientes, 20230
Study site
Chihuahua City, 31238
Study site
Cuernavaca, 62250
Study site
Durango, 34080
Study site
Guadalajara, 44340
Study site
Guadalajara, 44650
Study site
Mexico City, 10700
Study site
Monterrey, 66260
Study site
Pachuca, 42086
Russia8 sites
Study site
Moscow, 117036
Study site
Moscow, 125315
Study site
Moscow, 129090
Study site
Moscow, 129110
Study site
Moscow, 129327
Study site
Saint Petersburg, 197089
Study site
Saint Petersburg, 197198
Study site
Saratov, 410038
Romania5 sites
Study site
Bucharest, 020475
Study site
Bucharest
Study site
Cluj-Napoca, 400006
Study site
Galati, 800352
Study site
Ploieşti, 100163
Serbia3 sites
Study site
Belgrade, 11000
Study site
Kragujevac, 34000
Study site
Niš, 18000
About this study
Official title: A Randomized, Double-blind Study to Investigate the Effect of Aleglitazar on Glycemic Control in Patients With Type 2 Diabetes Mellitus.
This 6 arm study will assess the efficacy, safety, tolerability and pharmacokinetics of aleglitazar therapy in patients with Type 2 diabetes. Patients will be randomised to one of 6 treatment arms, to receive one of 4 doses of aleglitazar, Actos as an open-label active comparator, or placebo. Aleglitazar will be administered starting from a dose of 0.05mg po daily, and Actos will be administered at a dose of 45mg once daily. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- Actos, Placebo, aleglitazar
- 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.
ActosDrug
45mg po daily
PlaceboDrug
po daily
aleglitazarDrug
Administered po daily, at ascending doses with a starting dose (arm 1) of 0.05mg.
| Study group | Role | What they receive |
|---|---|---|
| Actos | Active comparator | Not described Receives: Drug: Actos |
| Aleglitazar 1 | Experimental | Not described Receives: Drug: aleglitazar |
| Aleglitazar 2 | Experimental | Not described Receives: Drug: aleglitazar |
| Aleglitazar 3 | Experimental | Not described Receives: Drug: aleglitazar |
| Aleglitazar 4 | Experimental | Not described Receives: Drug: aleglitazar |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change from baseline in Hemoglobin A1c (HbA1c)
Measured: 16 weeks
Secondary outcomes (2)
Absolute change from baseline in Fasting Plasma Glucose (FPG), HbA1c response rate, insulin sensitivity, beta cell function and cardiovascular markers.
Measured: 16 weeks
Adverse Events (AEs), laboratory parameters.
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2006 (estimated)
- Study startNov 2006
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus Type 2Studies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 332 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00388518
- Sponsor's protocol ID
- BM17864
- Status last verified
- Nov 2016
- First submitted
- 16 Oct 2006
- Last updated
- 2 Nov 2016
- Results posted
- No
Publications
Henry RR, Lincoff AM, Mudaliar S, Rabbia M, Chognot C, Herz M. Effect of the dual peroxisome proliferator-activated receptor-alpha/gamma agonist aleglitazar on risk of cardiovascular disease in patients with type 2 diabetes (SYNCHRONY): a phase II, randomised, dose-ranging study. Lancet. 2009 Jul 11;374(9684):126-35. doi: 10.1016/S0140-6736(09)60870-9. Epub 2009 Jun 8.
PubMed 19515415
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind Study to Investigate the Effect of Aleglitazar on Glycemic Control in Patients With Type 2 Diabetes Mellitus.
- ClinicalTrials.gov ID
- NCT00388518
- Acronym / sponsor ID
- BM17864
- Conditions
- Diabetes Mellitus Type 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 332 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 17 Oct 2006 (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.
This 6 arm study will assess the efficacy, safety, tolerability and pharmacokinetics of aleglitazar therapy in patients with Type 2 diabetes. Patients will be randomised to one of 6 treatment arms, to receive one of 4 doses of aleglitazar, Actos as an open-label active comparator, or placebo. Aleglitazar will be administered starting from a dose of 0.05mg po daily, and Actos will be administered at a dose of 45mg once daily. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Actos | Active comparator | Drug: Actos |
| Aleglitazar 1 | Experimental | Drug: aleglitazar |
| Aleglitazar 2 | Experimental | Drug: aleglitazar |
| Aleglitazar 3 | Experimental | Drug: aleglitazar |
| Aleglitazar 4 | Experimental | Drug: aleglitazar |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adult patients, 18-75 years of age;
- type 2 diabetes, diagnosed >=1 month of screening;
- either drug-naive, or pretreated with a maximum of 2 oral antihyperglycemic agents at submaximal doses;
- HbA1c <=10.0% at screening, and 7.0-10.0% at pre-randomisation visit.
Key exclusion criteria (4 listed)
- type 1 diabetes;
- currently or previously treated with insulin, a thiazolidinedione, or a dual Peroxisome Proliferator Activated Receptor (PPAR) agonist;
- clinically significant cardiovascular disease;
- Congestive Heart Failure (CHF) New York Heart Association (NYHA) 3-4.
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 |
|---|---|---|
| Actos45mg po daily | Drug | Actos |
| Placebopo daily | Drug | Placebo |
| aleglitazarAdministered po daily, at ascending doses with a starting dose (arm 1) of 0.05mg. | Drug | Aleglitazar 1, Aleglitazar 2, Aleglitazar 3, Aleglitazar 4 |
Primary outcome
Absolute change from baseline in Hemoglobin A1c (HbA1c)
Time frame: 16 weeks
2 secondary outcomes
Absolute change from baseline in Fasting Plasma Glucose (FPG), HbA1c response rate, insulin sensitivity, beta cell function and cardiovascular markers.
Time frame: 16 weeks
Adverse Events (AEs), laboratory parameters.
Time frame: Throughout study
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 2 Nov 2016.
- Derived from this study: PubMed 19515415Henry RR, Lincoff AM, Mudaliar S, Rabbia M, Chognot C, Herz M. Effect of the dual peroxisome proliferator-activated receptor-alpha/gamma agonist aleglitazar on risk of cardiovascular disease in patients with type 2 diabetes (SYNCHRONY): a phase II, randomised, dose-ranging study. Lancet. 2009 Jul 11;374(9684):126-35. doi: 10.1016/S0140-6736(09)60870-9. Epub 2009 Jun 8.
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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.
Clinical Trials study director
Hoffmann-La Roche
55 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Actos and aleglitazar in people with Diabetes Mellitus Type 2, run by Hoffmann-La Roche at 55 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 4 inclusion and 4 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 2 Nov 2016. 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, Italy, Mexico, Russia, Romania 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. 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 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 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?
Absolute change from baseline in Hemoglobin A1c (HbA1c) (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00388518, which also lists 1 linked publication.
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 2 Nov 2016; AzTrials last refreshed its copy on 7 Nov 2026.