A Study of Aleglitazar in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Metformin Alone
NCT ID: NCT01691846
Last Updated: 2017-02-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
200 participants
INTERVENTIONAL
2012-10-31
2013-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of Aleglitazar in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Sulfonylurea Alone or Sulfonylurea Plus Metformin Therapy
NCT01691989
Mitiglinide in Combination With Metformin vs. Metformin Alone in Patients With Type 2 Diabetes Mellitus
NCT00519142
A Study to Evaluate the Effect of ASP1941 in Combination With Metformin in Adult Patients With Type 2 Diabetes Mellitus
NCT01117584
Effect of Combination of Mitiglinide and Metformin on Glycemic Control in Patients With Type 2 Diabetes Mellitus
NCT01037842
Phase 4: Investigational Study to Evaluate Metformin XR Monotherapy Versus Metformin IR Monotherapy in Subjects With Type 2 Diabetes
NCT01864174
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
aleglitazar
aleglitazar+metformin
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
placebo+metformin
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)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
aleglitazar+metformin
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+metformin
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)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hoffmann-La Roche
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Chino, California, United States
Hawaiian Gardens, California, United States
Los Angeles, California, United States
Santa Ana, California, United States
Thousand Oaks, California, United States
West Hills, California, United States
Kissimmee, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Avon, Indiana, United States
Bethesda, Maryland, United States
Springfield, Missouri, United States
Toms River, New Jersey, United States
Altoona, Pennsylvania, United States
Beaver, Pennsylvania, United States
Morrisville, Pennsylvania, United States
Scranton, Pennsylvania, United States
Tipton, Pennsylvania, United States
Knoxville, Tennessee, United States
Dallas, Texas, United States
Richmond, Virginia, United States
Spokane, Washington, United States
Buenos Aires, , Argentina
Caba, , Argentina
Rosario, , Argentina
Cuernavaca, , Mexico
Culiacán, , Mexico
Guadalajara, , Mexico
Mexico City, , Mexico
Pachuca, , Mexico
Tampico, , Mexico
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BC28035
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.