Overview

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

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Biodel
Treatments:
Biphasic Insulins
Insulin
Insulin Lispro
Insulin, Globin Zinc
Insulin, Isophane
Criteria
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