drugset / Trial / NCT01194258
Safety/Efficacy Study of Subcutaneously Injected Prandial Insulins Compared to Insulin Lispro Alone in Patients With Type 2 Diabetes Mellitus
RandomizedCrossoverQuadruple-blindTreatment
Summary
The purpose of the study was to compare Humalog (insulin lispro)-recombinant human hyaluronidase PH20 (rHuPH20) or Novolog (insulin aspart)-rHuPH20 to insulin lispro for the treatment of Type 2 diabetes mellitus (T2DM) in basal-bolus therapy.
Timeline
- Start
- 2010-08
- Primary completion
- 2011-08
- Completion
- 2011-08
Outcome
Met primary endpoint
release “clinical trials of its ultrafast rHuPH20 insulin analog formulations in patients with Type 1 and Type 2 diabetes. Both trials met the primary endpoint” halozyme.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Insulin Lispro | Protein / enzyme biologic | — | Subcutaneous |
| Subject | Recombinant human hyaluronidase PH20 | Protein / enzyme biologic | — | Subcutaneous |
| Subject | insulin aspart | Protein / enzyme biologic | — | Subcutaneous |
| Background | Insulin glulisine | Protein / enzyme biologic | — | Subcutaneous |
| Background | insulin glargine | Protein / enzyme biologic | — | Subcutaneous |