Pharmacokinetic and Injection Site Toleration of BIOD-238 and BIOD-250 Compared to Humalog® in Subjects With Type 1 Diabetes

Study Overview
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Brief Summary
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A Double-blind Study of the Pharmacokinetic Properties of BIOD-238 and BIOD-250 Compared to Humalog® in Subjects with Type 1 Diabetes

Detailed Description
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The purpose of this study is to assess the speed of absorption of BIOD-238 and BIOD-250 compared to Humalog®. Secondary objectives are to assess other pharmacokinetic characteristics of BIOD-238 and BIOD-250 compared to Humalog®, and to evaluate the safety and tolerability of BIOD-238 and BIOD-250 compared to Humalog®.

Official Title
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A Double-blind Study of the Pharmacokinetic Properties of BIOD-238 and BIOD-250 Compared to Humalog® in Subjects With Type 1 Diabetes Including Assessments of Safety and Injection Site Toleration

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Drug: Insulin LISPRO
* Drug: Insulin LISPRO
* Drug: Insulin LISPRO


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: ≥18 to ≤70 years Body Mass Index: ≥18 and ≤35 kg/m2 Diagnosed with Type 1 Diabetes Mellitus for at least 1 year Exclusion Criteria: Type 2 diabetes mellitus Serum C-peptide >1.0 ng/mL HbA1c >10.0% History of hypersensitivity to any of the components in the study medication Treatment with any other investigational drug in the last 30 days before dosing. Current drug or alcohol abuse, or a history of drug or alcohol abuse which in the opinion of the Investigator will impair subject safety, protocol compliance, or interpretation of study results. Caffeine, nicotine or alcohol addiction which might be expected to result in withdrawal symptoms during the course of a study dosing day would fall into this category.

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-238<br>Subcutaneous injection | Drug: Insulin LISPRO<br> <br> |
| Experimental: BIOD-250<br>Subcutaneous injection | Drug: Insulin LISPRO<br> <br> |
| Active Comparator: Humalog<br>Subcutaneous injection | Drug: Insulin LISPRO<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to 1/2 maximal insulin concentration |  | 480 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to maximal insulin concentration |  | 480 minutes | 
| Time to 1/2 maximal insulin concentration after peak |  | 480 minutes | 
| Visual analog scale |  | 30 minutes | 
| AUC 0-30 and AUC 0-60 |  | 60 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes