The purpose of this study is to evaluate the safety and efficacy of BIOD-123 compared to insulin lispro (Humalog®) when used as part of a basal-bolus regimen in patients with type 1 diabetes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
132
Change in HbA1C
Time frame: Baseline and 18 week treatment period
Hypoglycemic event rates
Time frame: Baseline and 18 week treatment period
Insulin dose
Time frame: Baseline and 18 week treatment period
Daily blood glucose measures
Time frame: Baseline and 18 week treatment period
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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
...and 24 more locations