A Safety, Pharmacokinetics and Pharmacodynamics Study of RO6811135 in Patients With Type 2 Diabetes Mellitus
NCT ID: NCT01789788
Last Updated: 2016-11-02
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
PHASE1
56 participants
INTERVENTIONAL
2013-03-31
2013-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Placebo
Placebo
Matching placebo, multiple doses
RO6811135
RO6811135
multiple ascending doses
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Placebo
Matching placebo, multiple doses
RO6811135
multiple ascending doses
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Type 2 diabetes mellitus according to WHO criteria diagnosed for at least 3 months prior to screening
* On stable dose of metformin for at least 2 months prior to screening
* Fasting plasma glucose during the screening period \</= 240 mg/dL
* Hemoglobin A1c (HbA1c) levels at screening \>/= 6.5% and \</= 10.5%
* Evidence of insulin secretory capacity at screening
* Body mass index (BMI) 27 to 42 kg/m2, inclusive
* Females of child-bearing potential and males with female partners of child-bearing potential must agree to use effective contraception as defined by protocol
Exclusion Criteria
* Acquired or secondary forms of diabetes such as those resulting from pancreatic surgery/injury, cystic fibrosis related diabetes
* History of acute metabolic complications such as diabetic ketoacidosis or state of hyperosmolar hyperglycemia
* Evidence or history of clinically significant diabetic complications such as clinically severe diabetic peripheral neuropathy, clinically significant nephropathy as judged by the investigator, or pre-proliferative/proliferative diabetic retinopathy as judged by the investigator
* History of severe symptomatic hypoglycemia (requiring assistances of a third party) within 6 months prior to screening
* History or presence of clinically significant concomitant disease or disorder
* Hemoglobin level below the lower limit of reference range at screening
* Pregnant or lactating women
* History of anaphylaxis or severe systemic hypersensitivity or allergic reactions
18 Years
65 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.
Chula Vista, California, United States
Cincinnati, Ohio, United States
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.
BP28436
Identifier Type: -
Identifier Source: org_study_id