drugset / Trial / NCT01194245
Safety/Efficacy Study of Subcutaneously Injected Prandial Insulins Compared to Insulin Lispro Alone in Participants With Type 1 Diabetes Mellitus
RandomizedCrossoverQuadruple-blindTreatment
Summary
The purpose of the study is to compare Humalog (Insulin lispro)-recombinant human hyaluronidase (rHuPH20) or Novolog (Insulin aspart)-rHuPH20 to Humalog (Insulin lispro) for the treatment of Type 1 Diabetes Mellitus (T1DM) in basal-bolus therapy.
Timeline
- Start
- 2010-08
- Primary completion
- 2011-08
- Completion
- 2011-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Insulin Lispro | Protein / enzyme biologic | 100 unknown | Subcutaneous |
| Subject | insulin aspart | Protein / enzyme biologic | 100 unknown | Subcutaneous |
| Subject | rHuPH20 | Protein / enzyme biologic | 5 ug/ml | Subcutaneous |
| Background | Insulin glulisine | Protein / enzyme biologic | 100 unknown | Subcutaneous |
| Background | insulin glargine | Protein / enzyme biologic | 100 unknown | Subcutaneous |