drugset / Trial / NCT02324309
BIOD-531 vs. Humalog Mix 75/25 vs. Humulin R U-500 Post-Meal Glucose Control in Patients With Severe Insulin Resistance
RandomizedCrossoverSingle-blindTreatment
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.
Timeline
- Start
- 2014-05
- Primary completion
- 2014-11
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BIOD-531 | Protein / enzyme biologic | 0.8 iu/kg | Subcutaneous |
| Subject | BIOD-531 | Protein / enzyme biologic | 1.2 iu/kg | Subcutaneous |
| Comparator | Humalog Mix 75/25 | Unknown | 0.8 iu/kg | Subcutaneous |
| Comparator | Humalog Mix 75/25 | Unknown | 1.2 iu/kg | Subcutaneous |
| Comparator | insulin aspart | Protein / enzyme biologic | 0.8 iu/kg | Subcutaneous |
| Comparator | insulin aspart | Protein / enzyme biologic | 1.2 iu/kg | Subcutaneous |