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

NCT ID: NCT01493115

Last Updated: 2012-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2012-04-30

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

Conditions

Type 1 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Sequence 1

Reference (insulin glargine) - Test1 (insulin glargine - new formulation dose 1) - Test2 (insulin glargine - new formulation dose 2)

Group Type: EXPERIMENTAL

Insulin glargine HOE901

Intervention Type: DRUG

Pharmaceutical form:solution for injection Route of administration: subcutaneous

Insulin glargine - New formulation HOE901

Intervention Type: DRUG

Pharmaceutical form:solution for injection Route of administration: subcutaneous

Sequence 2

Test1 (insulin glargine - new formulation dose 1) - Test2 (insulin glargine - new formulation dose 2) - Reference (insulin glargine)

Group Type: EXPERIMENTAL

Insulin glargine HOE901

Intervention Type: DRUG

Pharmaceutical form:solution for injection Route of administration: subcutaneous

Insulin glargine - New formulation HOE901

Intervention Type: DRUG

Pharmaceutical form:solution for injection Route of administration: subcutaneous

Sequence 3

Test2 (insulin glargine - new formulation dose 2) - Reference (insulin glargine) - Test1 (insulin glargine - new formulation dose 1)

Group Type: EXPERIMENTAL

Insulin glargine HOE901

Intervention Type: DRUG

Pharmaceutical form:solution for injection Route of administration: subcutaneous

Insulin glargine - New formulation HOE901

Intervention Type: DRUG

Pharmaceutical form:solution for injection Route of administration: subcutaneous

Interventions

Insulin glargine HOE901

Pharmaceutical form:solution for injection Route of administration: subcutaneous

Intervention Type: DRUG

Insulin glargine - New formulation HOE901

Pharmaceutical form:solution for injection Route of administration: subcutaneous

Intervention Type: DRUG

Other Intervention Names

Lantus®

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Investigational Site Number 392001

Fukuoka, , Japan

Countries

Japan

Other Identifiers

U1111-1120-0463

Identifier Type: OTHER

Identifier Source: secondary_id

PKD12270

Identifier Type: -

Identifier Source: org_study_id