Comparison of Postprandial Glucose Control Associated With BIOD-531 vs. Humalog Mix 75/25 vs. Humulin R U-500

Study Overview
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Brief Summary
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The study is 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.

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 Mix 75/25 in Subjects With Type 2 Diabetes Mellitus Who Are Treated With 50-200 Units of Insulin Per Day

Conditions
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Type 2 Diabetes Mellitus

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-65 BMI > 25 kg/m2 Type 2 Diabetes Mellitus HbA1c < 10.0% Subject uses 50-200 units of insulin/day Exclusion Criteria: Type 1 Diabetes Mellitus 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 injection of 0.6 U/kg immediately before the start of the standardized breakfast | Drug: BIOD-531<br> <br> |
| Active Comparator: Humalog Mix 75/25 pre-meal<br>Subcutaneous injection of 0.6 U/kg immediately before the start of the standardized breakfast | Drug: Humalog Mix 75/25<br> <br> |
| Active Comparator: Humulin R U-500<br>Subcutaneous injection of 0.6 U/kg immediately before the start of a standardized breakfast | Drug: Humulin R U-500<br> <br> |
| Experimental: BIOD-531 post-meal<br>Subcutaneous injection of 0.6 U/kg 20 minutes after the start of the standardized breakfast | Drug: BIOD-531<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-standardized meal glucose exposure (AUC) |  | 0-120 minutes after meal | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Speed of insulin absorption (Times to 50%, 90%, maximal insulin concentrations) |  | 0-720 minutes | 
| Insulin exposure (AUC) |  | Various time frames over 720 minutes | 
| Maximal insulin concentration |  | 0-720 minutes | 
| Post breakfast and post-lunch glucose exposure (AUC) |  | Various times frames over 720 minutes | 
| Post-breakfast and post-lunch maximal glucose concentrations |  | 0-720 minutes | 
| Injection site toleration (VAS and severity scales) |  | 30 minutes post injection | 
| Draize injection site erythema and edema scoring |  | 0-720 minutes |