Type1 Diabetes
Conditions
Brief summary
Primary Objective: To demonstrate equivalence in exposure to insulin glargine given as test formulation T and reference formulation R in steady state conditions after 6 once-daily subcutaneous (SC) doses Secondary Objective: * To assess relative Pharmacodynamic activity of the insulin glargine test formulation T to the insulin glargine reference formulation R in steady state conditions after 6 once-daily SC doses * To assess the safety and tolerability of the test and reference formulations of two new insulin glargine formulations
Detailed description
Total study duration per subject: 29 to 64 days including screening visit Duration of each part of the study for one subject: * Screening: 3 to 21 days before 1st dosing (Day -21 to Day -3) * Treatment Period 1 and 2: 8 days (dosing on 6 days) * Washout between last/1st dosing days of the treatment periods: 7-21 days (preferentially 7 days) End-of-Study Visit: 7-10 days after last dosing
Interventions
DRUGInsulin glargine new formulation HOE901
Pharmaceutical form: solution Route of administration: subcutaneous
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
: * Male or female subjects, between 18 and 64 years of age, inclusive, with diabetes mellitus type 1 for more than one year * Total insulin dose of \< 1.2 U/kg/day * Minimum usual basal insulin dose ≥ 0.2 U/kg/day * Body weight between 50.0 kg and 110.0 kg, Body Mass Index between 18.5 and 30.0 kg/m2 inclusive * Fasting negative serum C-peptide (\< 0.3 nmol/L) * Glycohemoglobin (HbA1c) ≤ 75 mmol/mol \[≤ 9.0%\] * Stable insulin regimen for at least 2 months prior to inclusion in study * Certified as otherwise healthy for Type-1 Diabetes mellitus patient * Laboratory parameters within the normal range * Women of childbearing potential with negative pregnancy test and use of a highly effective contraceptive method or women with confirmed postmenopausal status
Exclusion criteria
* Any history or presence of clinically relevant cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic (apart from diabetes mellitus type 1), hematological, neurological, psychiatric, systemic (affecting the body as a whole), ocular, gynecologic (if female), or infectious disease; any acute infectious disease or signs of acute illness. * More than one episode of severe hypoglycemia with seizure, coma or requiring assistance of another person during the past 6 months * Frequent severe headaches and / or migraine, recurrent nausea and / or vomiting (more than twice a month) * Symptomatic hypotension (whatever the decrease in blood pressure), or asymptomatic postural hypotension defined by a decrease in systolic blood pressure equal to or greater than 20 mmHg within three minutes when changing from the supine to the standing position * Presence or history of a drug allergy or clinically significant allergic disease according to the Investigator's judgment * Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol * Presence or history of drug or alcohol abuse (alcohol consumption \> 40 grams / day) * If female, pregnancy (defined as positive Beta Human Chorionic Gonadotropin test), breast-feeding * Known hypersensitivity to insulin glargine or excipients of the study drug * Any history or presence of deep leg vein thrombosis or a frequent appearance of deep leg vein thrombosis in first degree relatives (parents, siblings or children) 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 |
|---|---|
| Area under the serum insulin concentration curve within 24 hours (INS-AUC0-24) after dosing on Day 6 | 24-hours (D6 to D7) |
Secondary
| Measure | Time frame |
|---|---|
| Time to INS-Cmax (INS-tmax) | 24-hours (D6 to D7) |
| Time to reach 50% of INS-AUC0-24 (T50%-INS-AUC0-24) | 24-hours (D6 to D7) |
| Area under the body-weight-standardized Glucose Infusion Rate (GIR) within 24 hours (GIR-AUC0-24h) after dosing on Day 6 during the clamp | 24-hours (D6 to D7) |
| Maximum smoothed body weight standardized glucose infusion rate (GIRmax) | 24-hours (D6 to D7) |
| Maximum insulin concentration (INS-Cmax) | 24-hours (D6 to D7) |
| Time to reach at least 50% of GIR-AUC0-24 (T50%-GIR-AUC0-24) | 24-hours (D6 to D7) |
| Duration of blood glucose control (time to elevation of smoothed blood glucose profile above clamp level and to elevation above different prespecified blood glucose levels) | 24-hours (D6 to D7) |
| Safety as measured by adverse events/serious adverse events, ohypoglycemia events, physical examinations, clinical laboratory, electrocardiograms, vital signs, injection site reactions and anti-insulin antibodies. | up to 9 weeks |
| Time to GIRmax (GIR-Tmax) | 24-hours (D6 to D7) |
Countries
Germany
Outcome results
None listed