Type 1 Diabetes
Conditions
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
Interventions
DRUGInsulin Lispro SAR342434
Pharmaceutical form:solution for injection Route of administration: subcutaneous
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
: * Male or female patients, between 18 and 64 years of age, inclusive, with diabetes mellitus type 1 for more than one year * Total insulin dose of \<1.0 U/kg/day * Fasting serum C-peptide \<0.30 nmol/L at screening * Glycohemoglobin (HbA1c) ≤75 mmol/mol (≤9%) at screening * Stable insulin regimen for at least 2 months prior to study (day of insulin regimen switch, with respect to safety of the patient and scientific integrity of the study). * Patients with anti-insulin antibody titer at screening ≤ 30.0 kU/L * Body weight between 50.0 kg and 100.0 kg, inclusive, il male , and between 40.0 and 90.0 kg, inclusive, if female, Body Mass Index between 18 and 30.0 kg/m², inclusive
Exclusion criteria
* Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness or any history or presence of HIT-type II (heparin induced thrombocytopenia Type II) * More than 1 episode of severe hypoglycemia resulting in coma/seizures or requiring assistance of another person, and/or hospitalization for diabetic ketoacidosis in the last 6 months before screening visit. * Frequent headaches and/or migraine, recurrent nausea and/or vomiting (for vomiting only, more than twice a month). * Symptomatic postural hypotension, irrespective of the decrease in blood pressure, or asymptomatic postural hypotension defined as a decrease in systolic blood pressure ≥20 mmHg within 3 minutes when changing from supine to standing position. * Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician. * Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol * If female, pregnancy (defined as positive β-HCG blood test), breast-feeding The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Assessment of PK parameter:INS-t1/2z | 10 hours | INS terminal half life |
| 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-max | 8 hours | Maximum smoothed GIR |
| Assessment of PK parameter:INS-AUC | 10 hours | Area under INS concentration time curve from 0 to infinity |
| Duration of blood glucose control | 8 hours | Duration of blood glucose control at or below 105 mg/dL |
| Adverse Events | Up to Day 62 | Number of participants with adverse events |
| Assessment of PD parameter:GIR-tmax | 8 hours | Time to reach GIR-max |
| Assessment of PK parameter:INS-tmax | 10 hours | Time to reach INS-Cmax |
Countries
Germany
Outcome results
None listed