Type 1 Diabetes Mellitus
Conditions
Brief summary
Primary Objective: * to assess the relative bioavailability of a single dose of insulin glargine (Lantus) and lixisenatide given subcutaneously as on-site mix versus separate and simultaneous injections of each drug Secondary Objectives: * to compare the activity of a single dose of insulin glargine and lixisenatide given subcutaneously as on-site mix versus separate and simultaneous injections of each drug * to assess the safety and tolerability of insulin glargine and lixisenatide given subcutaneously as on-site mix
Detailed description
The study period for one patient is one month in average and it can last up to 7 months (+ 2 weeks) with post-study and follow-up visits
Interventions
Pharmaceutical form:solution for injection Route of administration: subcutaneous
Pharmaceutical form:solution for injection Route of administration: subcutaneous
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Subjects with type 1 diabetes mellitus for more than one year with total insulin dose of \<1.2 U.kg/day, but otherwise healthy with glycohemoglobin (HbA1c) ≤ 9.0%, stable insulin regimen for at least 2 months prior to study, normal finding in medical history and physical examination.
Exclusion criteria
* any history or presence of clinically relevant cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic (apart from diabetes mellitus type I), 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, or asymptomatic postural hypotension defined by a decrease in systolic blood pressure (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 to 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 within 14 days before inclusion, or within 5 times the elimination 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) * History of unexplained pancreatitis, chronic pancreatitis and/or pancreatectomy 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 plasma lixisenatide concentration curve (LIX-AUClast) | 1 day (D1 to D2) in the first treatment period and 1 day (D1 to D2) during the second treatment period |
| Lixisenatide maximum plasma/serum peak concentration (LIX-Cmax) | 1 day (D1 to D2) in the first treatment period and 1 day (D1 to D2) during the second treatment period |
Secondary
| Measure | Time frame |
|---|---|
| Area under the body weight standardized glucose infusion rate curve (GIR) within 24 h (GIR-AUC0-24) | 1 day (D1 to D2) in the first treatment period and 1 day (D1 to D2) during the second treatment period |
| Time to 50% of the GIR-AUC within 24 h (T50%-GIR AUC0-24) | 1 day (D1 to D2) in the first treatment period and 1 day (D1 to D2) during the second treatment period |
| Area under the plasma lixisenatide concentration curve (AUC) | 1 day (D1 to D2) in the first treatment period and 1 day (D1 to D2) during the second treatment period |
| Time to GIRmax (GIR-Tmax) | 1 day (D1 to D2) in the first treatment period and 1 day (D1 to D2) during the second treatment period |
| Maximum smoothed body weight standardized glucose infusion rate GIRmax | 1 day (D1 to D2) in the first treatment period and 1 day (D1 to D2) during the second treatment period |
| Time to Cmax (Tmax ) for lixisenatide | 1 day (D1 to D2) in the first treatment period and 1 day (D1 to D2) during the second treatment period |
Countries
Germany
Outcome results
None listed