A Study Evaluating Safety and Efficacy of BIOD-123 Compared to Insulin Lispro (Humalog®)

Completed · Phase 2

Conditions studied: Type 1 Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT01686620

Run by

Biodel

People needed

132

Starts

2012-08-01

Expected to finish

2013-06-01

Last updated by the study team

2015-07-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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