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