A Study to Compare Pharmacodynamics and Pharmacokinetics of Insulin Glargine 300 U/mL (Toujeo®) to Insulin Degludec (Tresiba®) Under Steady State in Subjects with Type 1 Diabetes Mellitus (T1DM)
- Conditions
- MedDRA version: 18.1Level: PTClassification code 10067584Term: Type 1 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersType1 Diabetes MellitusTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2015-004843-38-DE
- Lead Sponsor
- Sanofi-Aventis Groupe
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
-Male or female subjects with T1DM for more than 1 year.
-Total insulin dose of <1.2 U/kg/day.
-Fasting negative serum C-peptide (<0.30 nmol/L).
-Glycohemoglobin (HbA1c) =9%.
-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 musculoskeletal system), vital signs, electrocardiogram (ECG), and safety laboratory.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 48
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
-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).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br><br>;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<br><br>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 Outcome Measures
Name Time Method Secondary end point(s): - Glucose infusion rate (GIR) over time during steady state clamp conditions<br>- Pharmacokinetics of insulin glargine<br>- Pharmacokinetics of insulin degludec<br>- Number (%) of patients with treatment emergent adverse events;Timepoint(s) of evaluation of this end point: 24 hours<br>- Glucose infusion rate (GIR) over time during steady state clamp conditions<br>- Pharmacokinetics of insulin glargine<br>- Pharmacokinetics of insulin degludec<br><br><br>22 days<br>- Number (%) of patients with treatment emergent adverse events