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

Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 1 Diabetes Mellitus

Intervention: Insulin glargine HOE901 (Drug); Insulin glargine - New formulation HOE901 (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Sanofi

Official(s) and/or principal investigator(s):
Clinical Sciences & Operations, Study Director, Affiliation: Sanofi

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

Clinical Details

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

Primary outcome: Glucose infusion rate

Secondary outcome:

Pharmacokinetic parameter : Cmax

Pharmacokinetic parameter : Tmax

Pharmacokinetic parameter : AUC

Number of patients with adverse events

Safety-related parameters including electrocardiogram, vital signs and laboratory tests

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

Minimum age: 20 Years. Maximum age: 65 Years. Gender(s): Both.

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.

Locations and Contacts

Investigational Site Number 392001, Fukuoka-Shi 812-0025, Japan
Additional Information

Starting date: November 2011
Last updated: April 30, 2012

Page last updated: August 23, 2015

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