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

Biodel

Status and phase

Suspended

Phase 2

Conditions

Diabetes Mellitus

Treatments

Drug: Humalog® Mix 75/25

Drug: BIOD-531

Study type

Interventional

Funder types

Industry

Identifiers

NCT02446028

3-250

Details and patient eligibility

About

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.

Full description

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.

Enrollment

13 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.