BIOD-531 vs. Humalog Mix 75/25 vs. Humulin R U-500 Post-Meal Glucose Control in Patients With Severe Insulin Resistance

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The study is designed 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 in patients with diabetes and severe insulin resistance.

• 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:

• BMI > 25 kg/m2

• Diabetes Mellitus using ≥ 150 units of insulin or insulin analog per day and/or ≥ 100 units of insulin or insulin analog at a single dosing session for at least 1 month prior to screening

• HbA1c < 10.0%

Exclusion Criteria:

• 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