A Bioequivalence Study Comparing Two Different Strengths Formulations of Insulin Lispro in Patients With Type 1 Diabetes
- Conditions
- Type 1 Diabetes
- Interventions
- Drug: Insulin Lispro SAR342434
- Registration Number
- NCT03903016
- Lead Sponsor
- Sanofi
- Brief Summary
Primary Objective:
To demonstrate bioequivalence between insulin lispro given as SAR342434, 200 Units/ml test formulation (T) and insulin lispro 100 Units/ml reference formulation (R) after a single subcutaneous (SC) dose
Secondary Objectives:
* To assess the pharmacodynamic profiles and further pharmacokinetic characteristics of the test formulation (T) in comparison to the reference formulation (R) after a single SC dose
* To assess the safety and tolerability of the test and the reference formulation of insulin lispro
- Detailed Description
Study duration per participant is approximately 62 days including a screening period up to 28 days before first dose, 2 periods of 2 days, a wash out period of 5 to 18 days (preferred7 days) and an end of study visit 7 to 14 days after the last dose
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Test (T) Insulin Lispro SAR342434 Insulin Lispro (SAR342434), 200 Units/ml, single dose on day 1 of each period Reference (R) Insulin Lispro SAR342434 Insulin Lispro Sanofi® ,100 Units/ml, single dose on day 1 of each period
- Primary Outcome Measures
Name Time Method Assessment of pharmacokinetc (PK) parameter:INS-Cmax 10 hours Maximum Insulin (INS) concentration
Assessment of PK parameter :INS-AUClast - 10 hours Area under INS concentration time curve from 0 to last measurable concentration -
- Secondary Outcome Measures
Name Time Method Assessment of PK parameter:INS-t1/2z 10 hours INS terminal half life
Adverse Events Up to Day 62 Number of participants with adverse events
Assessment of PD parameter:GIR-max 8 hours Maximum smoothed GIR
Assessment of PK parameter:INS-AUC 10 hours Area under INS concentration time curve from 0 to infinity
Assessment of pharmacodynamic (PD) parameter:GIR-AUC0-8 8 hours Area under the Glucose Infusion Rate (GIR) time curve from 0 to 8 hours
Assessment of PD parameter:GIR-tmax 8 hours Time to reach GIR-max
Duration of blood glucose control 8 hours Duration of blood glucose control at or below 105 mg/dL
Assessment of PK parameter:INS-tmax 10 hours Time to reach INS-Cmax
Trial Locations
- Locations (1)
Investigational Site Number 2760001
🇩🇪Neuss, Germany