A Study Evaluating Safety and Efficacy of BIOD-123 Compared to Insulin Lispro (Humalog®)
A Randomized, Parallel Group Trial Evaluating Safety and Efficacy of BIOD-123 Compared to Insulin Lispro (Humalog®) in Subjects With Type 1 Diabetes Using Basal-bolus Insulin Injection Therapy
1 other identifier
interventional
132
1 country
34
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2012
Shorter than P25 for phase_2
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 13, 2012
CompletedFirst Posted
Study publicly available on registry
September 18, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedJuly 28, 2015
July 1, 2015
10 months
September 13, 2012
July 22, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in HbA1C
Baseline and 18 week treatment period
Secondary Outcomes (3)
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
Study Arms (2)
BIOD-123
EXPERIMENTALBIOD-123 used as prandial insulin
Lispro (Humalog)
ACTIVE COMPARATORLispro (Humalog) used as prandial insulin
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biodellead
Study Sites (34)
Anaheim Clinical Trials, LLC
Anaheim, California, 92801, United States
Profil Research Institute
Chula Vista, California, 91911, United States
John Muir Physician Network Clinical Research Center
Concord, California, 94520, United States
Scripps Whittier Diabetes Institute
La Jolla, California, 92037, United States
Private Practice - Richard Cherlin, MD.
Los Gatos, California, 95032, United States
Providence Clinical Research Pharmaseek
North Hollywood, California, 91606, United States
Monteagle Medical Center
San Francisco, California, 94110, United States
Mills-Peninsula Health Services
San Mateo, California, 94401, United States
The Center for Diabetes and Endocrine Care
Hollywood, Florida, 33021, United States
University of Miami Diabetes Research Institute
Miami, Florida, 33136, United States
Progressive Medical Research Pharmaseek
Port Orange, Florida, 32127, United States
Atlanta Diabetes Associates
Atlanta, Georgia, 30309-1764, United States
Endocrine Research Solutions
Roswell, Georgia, 30076, United States
Rocky Mountain Diabetes and Osteoporosis Center PA
Idaho Falls, Idaho, 83404, United States
MidAmerica Diabetes Associates, PA
Wichita, Kansas, 67226, United States
Kentucky Diabetes
Lexington, Kentucky, 40503, United States
Diabetes & Glandular Disease Research
Rockville, Maryland, 20852, United States
Henry Ford Health System
Detroit, Michigan, 48235, United States
Mercury Street Medical
Butte, Montana, 59701, United States
Desert Endocrinolgy
Henderson, Nevada, 89052, United States
Research Foundation of SUNY Upstate Medical University
Syracuse, New York, 13210, United States
Diabetes & Endocrinology Consultants, PC
Morehead City, North Carolina, 28557, United States
Sentral Clinical Research Services, LLC
Cincinnati, Ohio, 45236, United States
Oregon Health Sciences University
Portland, Oregon, 97239, United States
Texas Diabetes and Endocrinology
Austin, Texas, 78731, United States
Mountain Diabetes & Endrocrine Center
Dallas, Texas, 28803, United States
Dallas Diabetes and Endocrine Research Center
Dallas, Texas, 75006, United States
Research Institute of Dallas
Dallas, Texas, 75231, United States
Baylor Endocrine Center
Dallas, Texas, 75246, United States
Texas Diabetes and Endocrinology
Round Rock, Texas, 78681, United States
Sonterra Clinical Research
San Antonio, Texas, 78258, United States
Capital Clinical Research Center
Olympia, Washington, 98502, United States
Ranier Clinical Research, Inc
Renton, Washington, 98507, United States
Rockwood Clinic
Spokane, Washington, 99202, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2012
First Posted
September 18, 2012
Study Start
August 1, 2012
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
July 28, 2015
Record last verified: 2015-07