Type1 Diabetes Mellitus MedDRA version: 18.1 Level: PT Classification code 10067584 Term: Type 1 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: Toujeo 300 units/ml solution for injection in a cartridge
Product Name: Insulin glargine
Product Code: HOE901 - U300
Pharmaceutical Form: Solution for injection in cartridge
INN or Propose
Sponsors
Sanofi-Aventis Groupe
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Male or female subjects with T1DM for more than 1 year. -Total insulin dose of =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic (apart from T1DM), 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 or any history or presence of heparin induced thrombocytopenia Type II (HIT-type II). -More than 1 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. -Any medication (including medicine containing 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, anti-hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and anti HIV2 Ab), human immunodeficiency virus 1 antigen (HIV1 Ag).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the pharmacodynamic profile of Toujeo with Tresiba in steady state in a euglycemic clamp after 8 days once daily dosing regimen at 2 dose levels in T1DM patients ;Secondary Objective: To compare the pharmacokinetic profile of Toujeo with Tresiba in steady state in a euglycemic clamp after 8 days once daily dosing regimen at 2 dose levels in T1DM patients To assess safety and tolerability of Toujeo and Tresiba in 8 days once daily dosing regimen at 2 dose levels in T1DM patients. ;Primary end point(s): Individual fluctuation of the smoothed glucose infusion rate (GIR)0-24 in steady state (GIR-smFL0-24);Timepoint(s) of evaluation of this end point: 24 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Glucose infusion rate (GIR) over time during steady state clamp conditions - Pharmacokinetics of insulin glargine - Pharmacokinetics of insulin degludec - Number (%) of patients with treatment emergent adverse events;Timepoint(s) of evaluation of this end point: 24 hours - Glucose infusion rate (GIR) over time during steady state clamp conditions - Pharmacokinetics of insulin glargine - Pharmacokinetics of insulin degludec 22 days - Number (%) of patients with treatment emergent adverse events | — |
Countries
Germany
Outcome results
None listed