Pharmacokinetic and Pharmacodynamic Properties of BIOD-123 and BIOD-125 Compared to Humalog® in Subjects With Type 1 Diabetes Including Assessments of Injection Site Toleration

Study Overview
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Brief Summary
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The primary objective is to assess the speed of absorption of BIOD-123 and BIOD-125 and compare them to Humalog.

Detailed Description
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The primary objective is to assess the speed of absorption of BIOD-123 and BIOD-125 and compare them to Humalog. The secondary objectives are to assess other pharmacokinetic characteristics of BIOD-123 and BIOD-125 and compare those to Humalog®, to assess pharmacodynamic characteristics of BIOD-123 and BIOD-125 and compare those to Humalog®, and to evaluate the safety and tolerability of BIOD-123 and BIOD-125 compared to Humalog®

Official Title
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A Double-blind Study of the Pharmacokinetic and Pharmacodynamic Properties of BIOD-123 and BIOD-125 Compared to Humalog® in Subjects With Type 1 Diabetes Including Assessments of Safety and Injection Site Toleration

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Drug: BIOD-123
* Drug: BIOD-125
* Drug: Humalog


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: ≥18 - ≤70 years BMI: ≥18 - ≤30 kg/m2 Diagnosed with type 1 diabetes mellitus for at least 1 year Insulin antibody ≤10 μU/mL at screening Exclusion Criteria: Type 2 diabetes mellitus History of >2 severe hypoglycemic events within the 3 months prior to screening Serum C-peptide >1.0 ng/mL Hemoglobin A1c (HbA1c) >10.0% Females who were breast feeding, pregnant, or intending to become pregnant during the study A sexually active person who was not using adequate contraceptive methods Positive serology for human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C Abnormal ECG, safety lab, or physical examination results that were deemed clinically significant by the investigator

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BIOD-123<br>SC administration of 0.20 U/kg | Drug: BIOD-123<br> <br> |
| Experimental: BIOD-125<br>SC administration of 0.20 U/kg | Drug: BIOD-125<br> <br> |
| Active Comparator: Humalog<br>SC administration of 0.20 U/kg | Drug: Humalog<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Speed of absorption (TINS-50%-early) of BIOD-123 and BIOD-125 versus Humalog. | Subjects were to receive study drug at 3 separate dosing visits separated by 3-28 days. The estimated duration of study participation for 1 subject was approximately 12 weeks. The estimated duration of the study was approximately 6 months. | 0-30, 0-60, 0-90, 0-480, and 120-480 minutes |