Trials / Completed
CompletedNCT04012775
Efficacy and Safety of Insulin Rinsulin® NPH Compared to Humulin® NPH in Type 2 Diabetes Mellitus Patients
An Open-label, Randomized, Multi-center, Parallel-group Clinical Trial Comparing the Efficacy and Safety of Rinsulin® NPH ("Geropharm", Russia) With Humulin® NPH ("Lilly France", France) in Type 2 Diabetes Mellitus Patients
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 201 (actual)
- Sponsor
- Geropharm · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The study is designed to approve non-inferior efficacy and safety of Rinsulin® NPH compared to Humulin® NPH.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Insulin Humulin® NPH | 4 weeks of glucose-level based dose titration, 24 weeks of treatment with stable doses |
| BIOLOGICAL | Insulin Rinsulin® NPH | 4 weeks of glucose-level based dose titration, 24 weeks of treatment with stable doses |
Timeline
- Start date
- 2017-04-20
- Primary completion
- 2018-09-24
- Completion
- 2018-09-24
- First posted
- 2019-07-09
- Last updated
- 2019-07-09
Locations
14 sites across 1 country: Russia
Source: ClinicalTrials.gov record NCT04012775. Inclusion in this directory is not an endorsement.