Single Dose Study With a New Insulin Glargine Formulation and Lantus® in Japanese Patients With Type 1 Diabetes Mellitus

Type 1 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01493115
• Other study ID #: PKD12270
• Secondary ID: U1111-1120-0463
• Status: Completed
• Phase: Phase 1
• First received: November 29, 2011
• Last updated: April 30, 2012
• Start date: November 2011
• Est. completion date: April 2012

Study information

• Verified date: April 2012
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Drug:
• Insulin glargine HOE901
Pharmaceutical form:solution for injection Route of administration: subcutaneous
• Insulin glargine - New formulation HOE901
Pharmaceutical form:solution for injection Route of administration: subcutaneous

Locations

Country	Name	City	State
Japan	Investigational Site Number 392001	Fukuoka-Shi

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose infusion rate		up to day 2 of each period	No
Secondary	Pharmacokinetic parameter : Cmax		up to day 2 of each period	No
Secondary	Pharmacokinetic parameter : Tmax		up to day 2 of each period	No
Secondary	Pharmacokinetic parameter : AUC		up to day 2 of each period	No
Secondary	Number of patients with adverse events		up to day 3 of each period	Yes
Secondary	Safety-related parameters including electrocardiogram, vital signs and laboratory tests		up to day 3 of each period	Yes