Trials / Completed
CompletedNCT04079413
Efficacy and Safety of GP40071 Compared to NovoRapid® Penfill® in Type 1 Diabetes Mellitus Patients
An Open-label, Randomized, Multi-center, Parallel-group Clinical Trial Comparing the Efficacy and Safety of GP40071 (OOO "GEROPHARM", Russia) Compared to NovoRapid® Penfill® (Novo Nordisk A/S, Denmark) in Type 1 Diabetes Mellitus Patients
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 264 (actual)
- Sponsor
- Geropharm · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This trial is a multi-center, open-label, randomized, parallel group trial in adult patients with T1DM comparing the efficacy and safety of GP40071 (insulin aspart, GEROPHARM) with that of NovoRapid®.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GP40071 | GP40071, 100 per milliliters (U/mL) (dose range of 1 unit to 80 units) self-administered by SC injection, immediately (within 5-10 minutes) before meal intake. |
| DRUG | NovoRapid® Penfill® | NovoRapid® Penfill®, 100 per milliliters (U/mL) (dose range of 1 unit to 80 units) self-administered by SC injection, immediately (within 5-10 minutes) before meal intake. |
Timeline
- Start date
- 2019-06-03
- Primary completion
- 2020-01-21
- Completion
- 2020-01-21
- First posted
- 2019-09-06
- Last updated
- 2020-07-23
Locations
14 sites across 1 country: Russia
Source: ClinicalTrials.gov record NCT04079413. Inclusion in this directory is not an endorsement.