BIOD-531 vs. Humalog Mix 75/25 vs. Humulin R U-500 Post-Meal Glucose Control in Patients With Severe Insulin Resistance

Study Overview
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Brief Summary
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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.

Official Title
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A Single-blind Crossover Study of the Pharmacokinetic and Postprandial Glucose Dynamics of BIOD-531 Compared to Humulin® R U-500 and Humalog® Mix75/25™ in Subjects With Type 2 DM Who Are Treated With ≥ 150 Units of Insulin Per Day

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Drug: BIOD-531
* Drug: Humalog Mix 75/25
* Drug: Humulin R U-500
* Drug: BIOD-531


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI > 25 kg/m2 Diabetes Mellitus using ≥ 150 units of insulin or insulin analog per day and/or ≥ 100 units of insulin or insulin analog at a single dosing session for at least 1 month prior to screening HbA1c < 10.0% Exclusion Criteria: History of bariatric surgery Corticosteroid therapy Significant cardiovascular or other major organ disease Females who are breast feeding or pregnant A sexually active person not using adequate contraceptive methods

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BIOD-531 pre-meal<br>Subcutaneous injections of 1.2 U/kg before the start of a standardized breakfast and 0.8 U/kg before the start of a standardized dinner. | Drug: BIOD-531<br> <br> |
| Active Comparator: Humalog Mix 75/25 pre-meal<br>Subcutaneous injections of 1.2 U/kg before the start of a standardized breakfast and 0.8 U/kg before the start of a standardized dinner. | Drug: Humalog Mix 75/25<br> <br> |
| Active Comparator: Humulin R U-500 pre-meal<br>Subcutaneous injections of 1.2 U/kg before the start of a standardized breakfast and 0.8 U/kg before the start of a standardized dinner. | Drug: Humulin R U-500<br> <br> |
| Experimental: BIOD-531 post-meal<br>Subcutaneous injections of 1.2 U/kg 20 minutes after the start of a standardized breakfast and 0.8 U/kg 20 minutes after the start of a standardized dinner. | Drug: BIOD-531<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-breakfast glucose exposure (AUC) |  | 0-330 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Speed of insulin absorption (Times to 50%, 90%, maximal insulin concentrations) |  | 0-330 and 660-1020 minutes | 
| Insulin exposure (AUC) |  | 0-1440 minutes | 
| Maximal insulin concentration |  | 0-330 and 660-1020 minutes | 
| Post-lunch and post-dinner glucose exposures (AUC) |  | 330-660 and 660-1020 minutes | 
| Injection site toleration (VAS and severity scales) |  | 30 and 690 minutes |