A Study Evaluating Safety and Efficacy of BIOD-123 Compared to Insulin Lispro (Humalog®)
- Registration Number
- NCT01686620
- Lead Sponsor
- Biodel
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 132
- Established clinical diagnosis of type 1 diabetes, consistent with ADA classification criteria (Diabetes Care 35: S64-S71, 2012), for more than 1 year.
- 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.
- History of known hypersensitivity to any of the components in the study medication
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BIOD-123 BIOD-123 BIOD-123 used as prandial insulin Lispro (Humalog) Lispro (Humalog) Lispro (Humalog) used as prandial insulin
- Primary Outcome Measures
Name Time Method Change in HbA1C Baseline and 18 week treatment period
- Secondary Outcome Measures
Name Time Method Hypoglycemic event rates Baseline and 18 week treatment period Insulin dose Baseline and 18 week treatment period Daily blood glucose measures Baseline and 18 week treatment period
Related Research Topics
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Trial Locations
- Locations (33)
Anaheim Clinical Trials, LLC
🇺🇸Anaheim, California, United States
Baylor Endocrine Center
🇺🇸Dallas, Texas, United States
Desert Endocrinolgy
🇺🇸Henderson, Nevada, United States
Mountain Diabetes & Endrocrine Center
🇺🇸Dallas, Texas, United States
Dallas Diabetes and Endocrine Research Center
🇺🇸Dallas, Texas, United States
Profil Research Institute
🇺🇸Chula Vista, California, United States
Rocky Mountain Diabetes and Osteoporosis Center PA
🇺🇸Idaho Falls, Idaho, United States
Research Institute of Dallas
🇺🇸Dallas, Texas, United States
Monteagle Medical Center
🇺🇸San Francisco, California, United States
University of Miami Diabetes Research Institute
🇺🇸Miami, Florida, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Sentral Clinical Research Services, LLC
🇺🇸Cincinnati, Ohio, United States
Oregon Health Sciences University
🇺🇸Portland, Oregon, United States
Sonterra Clinical Research
🇺🇸San Antonio, Texas, United States
The Center for Diabetes and Endocrine Care
🇺🇸Hollywood, Florida, United States
John Muir Physician Network Clinical Research Center
🇺🇸Concord, California, United States
Mills-Peninsula Health Services
🇺🇸San Mateo, California, United States
Scripps Whittier Diabetes Institute
🇺🇸La Jolla, California, United States
Providence Clinical Research Pharmaseek
🇺🇸North Hollywood, California, United States
Private Practice - Richard Cherlin, MD.
🇺🇸Los Gatos, California, United States
Progressive Medical Research Pharmaseek
🇺🇸Port Orange, Florida, United States
Atlanta Diabetes Associates
🇺🇸Atlanta, Georgia, United States
Kentucky Diabetes
🇺🇸Lexington, Kentucky, United States
MidAmerica Diabetes Associates, PA
🇺🇸Wichita, Kansas, United States
Diabetes & Glandular Disease Research
🇺🇸Rockville, Maryland, United States
Mercury Street Medical
🇺🇸Butte, Montana, United States
Diabetes & Endocrinology Consultants, PC
🇺🇸Morehead City, North Carolina, United States
Research Foundation of SUNY Upstate Medical University
🇺🇸Syracuse, New York, United States
Texas Diabetes and Endocrinology
🇺🇸Round Rock, 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
Endocrine Research Solutions
🇺🇸Roswell, Georgia, United States