The study is designed to compare meal time glucose control associated with BIOD-531, a rapidly absorbed concentrated insulin to that associated with Humalog Mix 75/25 and Humulin R U-500 in patients with diabetes and severe insulin resistance.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
12
Profil Institute for Clinical Research, Inc. (PICR)
Chula Vista, California, United States
Post-breakfast glucose exposure (AUC)
Time frame: 0-330 minutes
Speed of insulin absorption (Times to 50%, 90%, maximal insulin concentrations)
Time frame: 0-330 and 660-1020 minutes
Insulin exposure (AUC)
Time frame: 0-1440 minutes
Maximal insulin concentration
Time frame: 0-330 and 660-1020 minutes
Post-lunch and post-dinner glucose exposures (AUC)
Time frame: 330-660 and 660-1020 minutes
Injection site toleration (VAS and severity scales)
Time frame: 30 and 690 minutes
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