A Study Evaluating Safety and Efficacy of BIOD 531 Compared to Humalog® Mix 75/25 in Subjects With Type 2 Diabetes

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and efficacy of BIOD-531 compared to Humalog®Mix 75/25 in patients with type 2 diabetes.

Detailed Description
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BIOD-531 is a formulation of recombinant human insulin with a biphasic absorption profile characterized by rapid absorption (to prevent meal-time rises in blood glucose) and a secondary longer (basal) phase. The purpose of this trial is to evaluate glucose control and safety of BIOD-531 compared to a pre-mixed insulin which is commonly used to provide both meal-time and long acting insulin.

Official Title
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A Randomized, Open-label Parallel Group Phase 2b Trial Evaluating Safety and Efficacy of BIOD 531 Compared to Humalog® Mix 75/25 in Subjects With Type 2 Diabetes

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Drug: BIOD-531
* Drug: Humalog® Mix 75/25


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Established clinical diagnosis of type 2 diabetes, consistent with ADA classification criteria for 6 months or longer. Body Mass Index 27 - 45 kg/square meter, inclusive. Screening HbA1c between 7.5 and 11.0%, inclusive. Up to two injections per day of U-100 basal (NPH, glargine, or detemir), pre-mixed, or self-mixed basal/prandial insulins or insulin analogs at stable total daily doses between 40 -200 units/day, inclusive, for ≥ 3 months prior to screening. Exclusion Criteria: Regular use of Humulin®R U-500 or sulfonylurea, exenatide (short-acting), repaglinide, or nateglinide within 1 month prior to screening. History of bariatric surgery. Subject has had one or more severe hypoglycemic episodes associated with seizure, coma, or unconsciousness within the past 6 months. History of known hypersensitivity to any of the components in the study medication. New York Heart Association (NYHA) Class III or IV functional capacity, unstable angina pectoris, myocardial infarction, severe peripheral vascular disease, ischemic strokes or transient ischemic attacks within 6 months of screening. Systolic blood pressure ≥ 180 mmHg or sitting diastolic blood pressure ≥ 100 mmHg confirmed on repeat during screening visit.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BIOD-531<br>BIOD-531 injected twice daily | Drug: BIOD-531<br> <br> |
| Active Comparator: Humalog® Mix 75/25<br>Humalog® Mix 75/25 injected twice daily | Drug: Humalog® Mix 75/25<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c |  | 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial glucose excursions |  | 18 weeks | 
| Change in weight |  | 18 weeks | 
| Hypoglycemic event rates |  | 18 weeks |