Diabetes Mellitus
Conditions
Brief summary
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
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.
Interventions
DRUGBIOD-531
DRUGHumalog® Mix 75/25
Sponsors
Biodel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c | 18 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Postprandial glucose excursions | 18 weeks |
| Change in weight | 18 weeks |
| Hypoglycemic event rates | 18 weeks |
Countries
United States
Outcome results
None listed