Clinical trial NCT01493115: Single Dose Study With a New Insulin Glargine Formulation and Lantus® in Japanese Patients With Type 1 Diabetes Mellitus
Official title: A Randomized, Double-blind, 3-sequence, 3-period Cross-over, Single-dose Study of a New Formulation of Insulin Glargine Compared to the Marketed Lantus® in Japanese Patients With Type 1 Diabetes Mellitus Using the Euglycemic Clamp Technique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2011-12-15
Enrollment: 18
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Primary Objective:

To compare the pharmacodynamic properties of two different doses of a new insulin glargine formulation with 0.4 U/kg Lantus®

Secondary Objective:

To compare the pharmacokinetic properties of two different doses of a new insulin glargine formulation with 0.4 U/kg Lantus® To assess the safety and tolerability of a new insulin glargine formulation

Detailed description: The study duration per patient will be 4 to 12 weeks including 3 treatment periods each separated by a wash-out period of 6-20 days

Eligibility criteria: Inclusion criteria:

* Japanese male or female subjects, between 20 and 65 years of age, inclusive, with type 1 diabetes mellitus for more than one year, as defined by the Japanese Diabetes Society
* Body weight between 50.0 kg and 95.0 kg
* Body Mass Index between 18.0 and 30.0 kg/m2 inclusive
* Stable insulin regimen for at least 2 months prior to study
* Certified as otherwise healthy for type 1 diabetes mellitus patient by assessment of medical history and physical examination
* Women of childbearing potential must have a negative pregnancy test and must use a highly effective method of birth control. During the entire study female subjects of child bearing potential must use two independent methods of contraception. The accepted double contraception methods include use of an intra-uterine device or hormonal contraception in addition to one of the following contraceptive options: 1) condom; 2) diaphragm 3) spermicide.

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
* Presence or history of a drug allergy or clinically significant allergic disease according to the Investigator's judgment
* Participation in a trial with any investigational drug during the past 4 months
* Symptoms of a clinically significant illness in the 3 months before the study, which, according to the investigator's opinion, could interfere with the purposes of the study
* 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
* Known hypersensitivity to insulin glargine or excipients of the study drug
* Any history or presence of deep leg vein thrombosis or a frequent appearance of deep leg vein thrombosis in first degree relatives (parents, siblings or children)

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Glucose infusion rate
timeFrame: up to day 2 of each period
Secondary outcomes:
measure: Pharmacokinetic parameter : Cmax
timeFrame: up to day 2 of each period
measure: Pharmacokinetic parameter : Tmax
timeFrame: up to day 2 of each period
measure: Pharmacokinetic parameter : AUC
timeFrame: up to day 2 of each period
measure: Number of patients with adverse events
timeFrame: up to day 3 of each period
measure: Safety-related parameters including electrocardiogram, vital signs and laboratory tests
timeFrame: up to day 3 of each period
Other outcomes:
Locations:
city: Fukuoka-Shi
country: Japan
facility: Investigational Site Number 392001
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: