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



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:August 2012
End Date:June 2013

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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

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.


Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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
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1085 N Harbor Blvd
Anaheim, California 92801
(714) 774-7777
Anaheim Clinical Trials, LLC Anaheim Clinical Trials (ACT) is a research center of excellence for...
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