Diabetes Mellitus Type 1
Conditions
Brief summary
The primary objective of this study is to assess the speed of absorption and onset of action of BIOD-105 and BIOD-107 and compare them to Humalog®.
Detailed description
The secondary objectives of this study are to assess other pharmacokinetic characteristics of BIOD-105 and BIOD-107 and compare those to Humalog®, to assess other pharmacodynamic characteristics of BIOD-105 and BIOD-107 and compare those to Humalog®, and to evaluate the safety and tolerability of BIOD-105 and BIOD-107 compared to Humalog®.
Interventions
DRUGInsulin LISPRO
Single doses of: 0.15 U/kg
Single doses of: 0.15 U/kg
Sponsors
Biodel
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Subjects must present with the following: 1. Body Mass Index: ≥ 18 - ≤ 28 kg/m2 2. Diagnosed with type 1 diabetes mellitus for at least 1 year 3. Insulin antibody less than or equal to 10 μU/mL at screening
Exclusion criteria
Subjects presenting with any of the following will not be included in the study: 1. Type 2 diabetes mellitus 2. Serum C-peptide \> 1.0 ng/mL 3. HbA1c \> 10.0% 4. History of hypersensitivity to any of the components in the study medication 5. Treatment with any other investigational drug in the last 30 days before screening visit 6. Regular smoking as assessed clinically by the Investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Speed of absorption | 480 minutes | The speed of absorption will be assessed by the time to reach 50% of maximum insulin concentration (TINS-50%-early, time before CINS max) and the onset of action will be assessed by the time to reach 50% of the maximum glucose infusion rate (TGIR-50%- early). |
Countries
United States
Outcome results
None listed