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

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

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.

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.

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.