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

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

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

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes Mellitus
• Intervention / Treatment: Drug: Insulin glargine HOE901; Drug: Insulin glargine - New formulation HOE901

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

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Fukuoka-Shi, Japan, 812-0025
    • Investigational Site Number 392001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence 1; Reference (insulin glargine) - Test1 (insulin glargine - new formulation dose 1) - Test2 (insulin glargine - new formulation dose 2)	Drug: Insulin glargine HOE901; Pharmaceutical form:solution for injection Route of administration: subcutaneous; Other Names: Lantus®; Drug: Insulin glargine - New formulation HOE901; Pharmaceutical form:solution for injection Route of administration: subcutaneous
Experimental: Sequence 2; Test1 (insulin glargine - new formulation dose 1) - Test2 (insulin glargine - new formulation dose 2) - Reference (insulin glargine)	Drug: Insulin glargine HOE901; Pharmaceutical form:solution for injection Route of administration: subcutaneous; Other Names: Lantus®; Drug: Insulin glargine - New formulation HOE901; Pharmaceutical form:solution for injection Route of administration: subcutaneous
Experimental: Sequence 3; Test2 (insulin glargine - new formulation dose 2) - Reference (insulin glargine) - Test1 (insulin glargine - new formulation dose 1)	Drug: Insulin glargine HOE901; Pharmaceutical form:solution for injection Route of administration: subcutaneous; Other Names: Lantus®; Drug: Insulin glargine - New formulation HOE901; Pharmaceutical form:solution for injection Route of administration: subcutaneous

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Glucose infusion rate	up to day 2 of each period

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetic parameter : Cmax	up to day 2 of each period
Pharmacokinetic parameter : Tmax	up to day 2 of each period
Pharmacokinetic parameter : AUC	up to day 2 of each period
Number of patients with adverse events	up to day 3 of each period
Safety-related parameters including electrocardiogram, vital signs and laboratory tests	up to day 3 of each period

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: November 29, 2011
• First Submitted That Met QC Criteria: December 13, 2011
• First Posted (Estimate): December 15, 2011

Study Record Updates

• Last Update Posted (Estimate): May 1, 2012
• Last Update Submitted That Met QC Criteria: April 30, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc; Insulin Glargine
• Other Study ID Numbers: PKD12270; U1111-1120-0463 (Other Identifier: UTN)