A Study Evaluating Safety and Efficacy of BIOD-123 Compared to Insulin Lispro (Humalog®)
NCT ID: NCT01686620
Last Updated: 2015-07-28
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
PHASE2
132 participants
INTERVENTIONAL
2012-08-31
2013-06-30
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.
Pharmacokinetic and Pharmacodynamic Properties of BIOD-123 and BIOD-125 Compared to Humalog® in Subjects With Type 1 Diabetes Including Assessments of Injection Site Toleration
NCT01908894
A Study Evaluating Safety and Efficacy of BIOD 531 Compared to Humalog® Mix 75/25 in Subjects With Type 2 Diabetes
NCT02446028
To Investigate the Efficacy and Safety of Individualized Doses of BioChaperone Insulin Lispro in Comparison to Humalog® U-100 in Patients With Type 1 Diabetes Mellitus
NCT02528396
A Double-blinded, Randomised, Three-period Crossover Euglycaemic Clamp Trial Investigating the Pharmacokinetics, Glucodynamics and Safety of BioChaperone Human Insulin, Human Insulin (Huminsulin® Normal) and Insulin Lispro (Humalog®) in Subjects With Type 1 Diabetes
NCT02213146
Pharmacokinetics and Pharmacodynamics of BIOD-961 vs. Marketed Glucagons
NCT02403648
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
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
BIOD-123
BIOD-123 used as prandial insulin
BIOD-123
Lispro (Humalog)
Lispro (Humalog) used as prandial insulin
Lispro (Humalog)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
BIOD-123
Lispro (Humalog)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age: 18 years old, or older.
* Body Mass Index: between 18 and 35 kg/m2, inclusive.
* Willing to use insulin glargine as the only basal insulin throughout the duration of the trial.
* Willingness not to use insulin pump treatment and only use the study glucose meter and CGM devices during the duration of the trial.
Exclusion Criteria
* Treatment with pramlintide or GLP-1 analogs within 30 days of screening or anticipated use of these medications during the course of the study.
* Treatment with oral or intravenous corticosteroids in the last 3 months prior to screening. Standard doses of inhalational corticosteroid used as part of a long term treatment regimen are allowed.
* Consistent recent hypoglycemic unawareness within the last six months
* History of more than two severe hypoglycemic events within six months prior to screening
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Biodel
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Anaheim Clinical Trials, LLC
Anaheim, California, United States
Profil Research Institute
Chula Vista, California, United States
John Muir Physician Network Clinical Research Center
Concord, California, United States
Scripps Whittier Diabetes Institute
La Jolla, California, United States
Private Practice - Richard Cherlin, MD.
Los Gatos, California, United States
Providence Clinical Research Pharmaseek
North Hollywood, California, United States
Monteagle Medical Center
San Francisco, California, United States
Mills-Peninsula Health Services
San Mateo, California, United States
The Center for Diabetes and Endocrine Care
Hollywood, Florida, United States
University of Miami Diabetes Research Institute
Miami, Florida, United States
Progressive Medical Research Pharmaseek
Port Orange, Florida, United States
Atlanta Diabetes Associates
Atlanta, Georgia, United States
Endocrine Research Solutions
Roswell, Georgia, United States
Rocky Mountain Diabetes and Osteoporosis Center PA
Idaho Falls, Idaho, United States
MidAmerica Diabetes Associates, PA
Wichita, Kansas, United States
Kentucky Diabetes
Lexington, Kentucky, United States
Diabetes & Glandular Disease Research
Rockville, Maryland, United States
Henry Ford Health System
Detroit, Michigan, United States
Mercury Street Medical
Butte, Montana, United States
Desert Endocrinolgy
Henderson, Nevada, United States
Research Foundation of SUNY Upstate Medical University
Syracuse, New York, United States
Diabetes & Endocrinology Consultants, PC
Morehead City, North Carolina, United States
Sentral Clinical Research Services, LLC
Cincinnati, Ohio, United States
Oregon Health Sciences University
Portland, Oregon, United States
Texas Diabetes and Endocrinology
Austin, Texas, United States
Mountain Diabetes & Endrocrine Center
Dallas, Texas, United States
Dallas Diabetes and Endocrine Research Center
Dallas, Texas, United States
Research Institute of Dallas
Dallas, Texas, United States
Baylor Endocrine Center
Dallas, Texas, United States
Texas Diabetes and Endocrinology
Round Rock, Texas, United States
Sonterra Clinical Research
San Antonio, Texas, United States
Capital Clinical Research Center
Olympia, Washington, United States
Ranier Clinical Research, Inc
Renton, Washington, United States
Rockwood Clinic
Spokane, Washington, 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.
3-201
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.