Diabetes Mellitus Type 2Phase 3NCT01691846
A Study of Aleglitazar in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Metformin Alone
A Phase 3 study testing aleglitazar+metformin in people with Diabetes Mellitus Type 2, run by Hoffmann-La Roche at 31 sites in 3 countries.
Trial summary
This multicenter, randomized, double-blind, placebo-controlled study will assess the efficacy, safety and tolerability of aleglitazar plus metformin combination therapy compared with placebo plus metformin in patients with type 2 diabetes mellitus who are inadequately controlled with metformin monotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus Type 2
- What is being tested?
- aleglitazar+metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 31 sitesin 3 countries
- Study dates
- Oct 2012to Sep 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients, >/=18 years of age
- Diagnosis of diabetes mellitus type 2
- Patients treated with stable metformin monotherapy for at least 12 weeks prior to screening
- HbA1c >/=7% and </=9.5% at screening or within 4 weeks prior to screening and at pre-randomization visit
- Fasting plasma glucose </=240 mg/dL at pre-randomization visit
- Agreement to maintain diet and exercise habits during the study
Who cannot join
- Patients with Type 1 diabetes mellitus, secondary diabetes, diabetes resulting from pancreatic injury, or acute metabolic diabetic complications within the past 6 months
- Any previous treatment with thiazolidinedione or a dual PPAR agonist
- Any body weight lowering or lipoprotein-modifying therapy within 12 weeks prior to screening (except stable dose of statin)
- Symptomatic congestive heart failure classified as New York Heart Association class II-IV at screening
Trial locations and contacts
31 sites in 3 countries.
31 sites in 3 countries
United States22 sites
Study site
Altoona, Pennsylvania, 16602
Study site
Atlanta, Georgia, 30338
Study site
Avon, Indiana, 46123
Study site
Beaver, Pennsylvania, 15009
Study site
Bethesda, Maryland, 20817
Study site
Chicago, Illinois, 60607
Study site
Chino, California, 91710
Study site
Dallas, Texas, 75230
Study site
Hawaiian Gardens, California, 90716
Study site
Kissimmee, Florida, 34741
Study site
Knoxville, Tennessee, 37919
Study site
Los Angeles, California, 90057
Study site
Morrisville, Pennsylvania, 19067
Study site
Richmond, Virginia, 23249
Study site
Santa Ana, California, 92701
Study site
Scranton, Pennsylvania, 18510
Study site
Spokane, Washington, 99202
Study site
Springfield, Missouri, 65807
Study site
Thousand Oaks, California, 91360
Study site
Tipton, Pennsylvania, 16684
Study site
Toms River, New Jersey, 08753
Study site
West Hills, California, 91307
Mexico6 sites
Study site
Cuernavaca, 62250
Study site
Culiacán, 80020
Study site
Guadalajara, 44650
Study site
Mexico City, 11650
Study site
Pachuca, 42060
Study site
Tampico, 89000
Argentina3 sites
Study site
Buenos Aires, 1056
Study site
Caba, C1428DCO
Study site
Rosario, S2000CXP
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study to Assess the Efficacy, Safety and Tolerability of Aleglitazar Plus Metformin Combination Therapy Compared With Placebo Plus Metformin in Patients With T2D Inadequately Controlled With Metformin Monotherapy
This multicenter, randomized, double-blind, placebo-controlled study will assess the efficacy, safety and tolerability of aleglitazar plus metformin combination therapy compared with placebo plus metformin in patients with type 2 diabetes mellitus who are inadequately controlled with metformin monotherapy. Patients will be randomized to receive oral doses of 150 mcg aleglitazar once daily or placebo. The anticipated time on study treatment is 26 weeks.
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- aleglitazar+metformin, placebo+metformin
- 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.
aleglitazar+metforminDrug
150 mcg aleglitazar given orally once a day for 26 weeks. Patients will continue on their existing dose and regimen of metformin (≥ 1500 mg/day or individual maximally tolerated dose)
placebo+metforminDrug
Oral doses of matching placebo once a day for 26 weeks. Patients will continue on their existing dose and regimen of metformin (≥ 1500 mg/day or individual maximally tolerated dose)
| Study group | Role | What they receive |
|---|---|---|
| aleglitazar | Experimental | Not described Receives: Drug: aleglitazar+metformin |
| placebo | Placebo comparator | Not described Receives: Drug: placebo+metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in hemoglobin HbA1c
Measured: From baseline to week 26
Secondary outcomes (6)
Change in lipid profile
Measured: From baseline to week 26
Change from baseline in fasting plasma glucose
Measured: From baseline to week 26
Responder rate as defined of hemoglobin HbAc1 <7.0% (<6.5%)
Measured: From baseline to week 26
Change from baseline in homeostatic index of insulin sensitivity (HOMA-IS)
Measured: From baseline to week 26
Change from baseline in homeostatic index of beta cell function (HOMA-BCF)
Measured: From baseline to week 26
Safety: incidence of adverse events
Measured: 30 weeks (26 weeks treatment and 4 weeks follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2012 (estimated)
- Study startOct 2012
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 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
- NCT01691846
- Sponsor's protocol ID
- BC28035
- Status last verified
- Feb 2017
- First submitted
- 20 Sep 2012
- Last updated
- 23 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study to Assess the Efficacy, Safety and Tolerability of Aleglitazar Plus Metformin Combination Therapy Compared With Placebo Plus Metformin in Patients With T2D Inadequately Controlled With Metformin Monotherapy
- ClinicalTrials.gov ID
- NCT01691846
- Acronym / sponsor ID
- BC28035
- Conditions
- Diabetes Mellitus Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 25 Sep 2012 (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 multicenter, randomized, double-blind, placebo-controlled study will assess the efficacy, safety and tolerability of aleglitazar plus metformin combination therapy compared with placebo plus metformin in patients with type 2 diabetes mellitus who are inadequately controlled with metformin monotherapy. Patients will be randomized to receive oral doses of 150 mcg aleglitazar once daily or placebo. The anticipated time on study treatment is 26 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| aleglitazar | Experimental | Drug: aleglitazar+metformin |
| placebo | Placebo comparator | Drug: placebo+metformin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult patients, >/=18 years of age
- Diagnosis of diabetes mellitus type 2
- Patients treated with stable metformin monotherapy for at least 12 weeks prior to screening
- HbA1c >/=7% and </=9.5% at screening or within 4 weeks prior to screening and at pre-randomization visit
- Fasting plasma glucose </=240 mg/dL at pre-randomization visit
Key exclusion criteria (4 listed)
- Patients with Type 1 diabetes mellitus, secondary diabetes, diabetes resulting from pancreatic injury, or acute metabolic diabetic complications within the past 6 months
- Any previous treatment with thiazolidinedione or a dual PPAR agonist
- Any body weight lowering or lipoprotein-modifying therapy within 12 weeks prior to screening (except stable dose of statin)
- Symptomatic congestive heart failure classified as New York Heart Association class II-IV at screening
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 |
|---|---|---|
| aleglitazar+metformin150 mcg aleglitazar given orally once a day for 26 weeks. Patients will continue on their existing dose and regimen of metformin (≥ 1500 mg/day or individual maximally tolerated dose) | Drug | aleglitazar |
| placebo+metforminOral doses of matching placebo once a day for 26 weeks. Patients will continue on their existing dose and regimen of metformin (≥ 1500 mg/day or individual maximally tolerated dose) | Drug | placebo |
Primary outcome
Change from baseline in hemoglobin HbA1c
Time frame: From baseline to week 26
6 secondary outcomes
Change in lipid profile
Time frame: From baseline to week 26
Change from baseline in fasting plasma glucose
Time frame: From baseline to week 26
Responder rate as defined of hemoglobin HbAc1 <7.0% (<6.5%)
Time frame: From baseline to week 26
Change from baseline in homeostatic index of insulin sensitivity (HOMA-IS)
Time frame: From baseline to week 26
Change from baseline in homeostatic index of beta cell function (HOMA-BCF)
Time frame: From baseline to week 26
Safety: incidence of adverse events
Time frame: 30 weeks (26 weeks treatment and 4 weeks follow-up)
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 23 Feb 2017.
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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
31 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing aleglitazar+metformin in people with Diabetes Mellitus Type 2, run by Hoffmann-La Roche at 31 sites in 3 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 6 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 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States, Mexico, Argentina. 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?
Change from baseline in hemoglobin HbA1c (time frame: From baseline to week 26). 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 23 Feb 2017.