Type 1 Diabetes Mellitus
Conditions
Brief summary
Primary Objective: \- To assess the total metabolic effect ratios of a new insulin glargine formulation versus Lantus® Secondary Objectives: * To assess the exposure ratios of a new insulin glargine formulation versus Lantus® * To compare the duration of action of a new insulin glargine formulation versus Lantus® * To explore the dose response and dose exposure relationship of a new insulin glargine formulation * To assess the safety and tolerability of a new insulin glargine formulation
Detailed description
The study period for one patient is one month in average and it can last up to 11 weeks broken down as follows: * Screening: 3 to 28 days * Treatment period: 1 to 4 days: 2 days (1 overnight stay) * Washout period: 5 to 18 days (preferentially 7 days between consecutive dosings) * End of study: 1 day after the last dosing
Interventions
Pharmaceutical form: Lantus solution for injection 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 65 Years
Healthy volunteers
No
Inclusion criteria
* Male or female subjects with diabetes mellitus type 1 for more than one year, * Total insulin dose of \<1.2 U/kg/day, * Glycohemoglobin (HbA1c) ≤ 9.0%, * Fasting negative serum C-peptide (\< 0.3 nmol/L), * Stable insulin regimen for at least 2 months prior to study, * Normal findings in medical history and physical examination (cardiovascular system, chest and lungs, thyroid, abdomen, nervous system, skin and mucosae, and musculo-skeletal system), vital signs, electrocardiogram (ECG) and safety lab, * 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 SBP 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, * Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol, * Pregnant or breast feeding women, * Any medication (including St John's Wort) within 14 days before inclusion, or within 5 times the elimination half-life or pharmacodynamic half-life of that drug, whichever the longest and regular use of any medication other than insulins in the last month before study start with the exception of thyroid hormones, lipid-lowering and antihypertensive drugs, and, if female, with the exception of hormonal contraception or menopausal hormone replacement therapy; any vaccination within the last 28 days, * Positive reaction to any of the following tests: hepatitis B surface (HBs Ag) antigen, antihepatitis B core antibodies (anti-HBc Ab) if compound having possible immune activities, anti-hepatitis C virus (anti-HCV2) antibodies, anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and anti HIV2 Ab), * Known hypersensitivity to insulin glargine and excipients, * Any history or presence of deep leg vein thrombosis. 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 |
|---|---|
| The area under the body weight standardized glucose infusion rate curve (GIR) within 36 hours (GIR-AUC0-36) | 36 hours (D1 to D2) in all four treatment periods |
Secondary
| Measure | Time frame |
|---|---|
| Time to 50% of the GIR-AUC0-36 (T50%-GIR AUC0-36) | 36 hours (D1 to D2) in all four treatment periods |
| Time to 50% of INS-AUC0-36 (T50% INS-AUC0-36) | 36 hours (D1 to D2) in all four treatment periods |
| The area under the insulin glargine concentration curve within 36 hours (INS-AUC0-36) - | 36 hours (D1 to D2) in all four treatment periods |
| Maximum smoothed body weight standardized glucose infusion rate GIRmax, and time to GIRmax (GIR-Tmax) | 36 hours (D1 to D2) in all four treatment periods |
| Maximum insulin concentration INS-Cmax, and time to Cmax (INS-Tmax) | 36 hours (D1 to D2) in all four treatment periods |
| Duration of blood glucose control (time to elevation of smoothed blood glucose profile above clamp level and to elevation above different pre-specified blood glucose levels) | 36 hours (D1 to D2) in all four treatment periods |
Countries
Germany
Outcome results
None listed