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)

• Register: EUCTR
• Last refreshed on: 17 October 2016
• Main ID: EUCTR2015-004843-38-DE
• Date of registration: 14/12/2015
• Prospective Registration: Yes
• Primary sponsor: Sanofi-Aventis Groupe
• Public title: 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)
• Scientific title: A Randomized, Double-blind, 2x2 Cross-over Euglycemic Clamp Study in Two Parallel Cohorts to Compare the Pharmacodynamic and Pharmacokinetic Properties of 0.4 and 0.6 U/kg/day Insulin Glargine (Toujeo®) with the Same Dose Levels of Insulin Degludec (Tresiba®) in Steady State After 8 Days Multiple Dosing Regimen in Patients with Diabetes Mellitus Type 1
• Date of first enrolment: 20/01/2016
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-004843-38
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: yes Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Germany

Contacts

• Affiliation: Sanofi-Aventis Deutschland GmbH

• Affiliation: Sanofi-Aventis Deutschland GmbH

Key inclusion & exclusion criteria

Inclusion criteria:
-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

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).



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

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

Intervention(s)

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 Proposed INN: INSULIN GLARGINE
CAS Number: 160337-95-1
Current Sponsor code: HOE901 - U300
Concentration unit: U/ml unit(s)/millilitre
Concentration type: equal
Concentration number: 300-

Trade Name: Tresiba 100 units/mL solution for injection in cartridge
Product Name: insulin degludec
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INSULIN DEGLUDEC
CAS Number: 844439-96-9
Concentration unit: U/ml unit(s)/millilitre
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)

Primary end point(s): Individual fluctuation of the smoothed glucose infusion rate (GIR)0-24 in steady state (GIR-smFL0-24)

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.

Timepoint(s) of evaluation of this end point: 24 hours

Secondary Outcome(s)

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

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

Secondary ID(s)

LPS14585

Source(s) of Monetary Support

Sanofi-Aventis Groupe