Trials / Completed
CompletedNCT04101383
A Study to Compare Pharmacokinetics and Pharmacodynamics of RinGlar® to Lantus® in Type 1 Diabetes Mellitus Patients
A Randomized Double Blinded Two-way Crossover Single-dose Pharmacokinetics and Pharmacodynamics Study of RinGlar® (LLC "GEROPHARM", Russia) Versus Lantus® (Sanofi-Aventis) in Type 1 Diabetes Mellitus Patients Using the Euglycemic Clamp Technique
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 42 (actual)
- Sponsor
- Geropharm · Industry
- Sex
- Male
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
Pharmacokinetics and pharmacodynamics study of 2 formulation of insulin glargine (RinGlar® GEROPHARM vers. Lantus® Sanofi-Aventis)
Detailed description
A randomized double blinded two-way crossover single-dose pharmacokinetics and pharmacodynamics study of RinGlar® (LLC "GEROPHARM", Russia) versus Lantus® (Sanofi-Aventis) in Type 1 Diabetes Mellitus Patients using the euglycemic clamp technique
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | RinGlar® | Single subcutaneous administration of RinGlar® in dose 0.6 Units/kg |
| DRUG | Lantus® | Single subcutaneous administration of Lantus® in dose 0.6 Units/kg |
Timeline
- Start date
- 2017-10-16
- Primary completion
- 2018-02-16
- Completion
- 2018-02-16
- First posted
- 2019-09-24
- Last updated
- 2019-09-24
Locations
2 sites across 1 country: Russia
Source: ClinicalTrials.gov record NCT04101383. Inclusion in this directory is not an endorsement.