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

NCT01493115 | Completed Phase 1

• 2 other identifiers: PKD12270U1111-1120-0463
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Glucose infusion rate

  up to day 2 of each period

Secondary Outcomes (5)

• 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

Study Arms (3)

Sequence 1

EXPERIMENTAL

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

Drug: Insulin glargine HOE901; Drug: Insulin glargine - New formulation HOE901

Sequence 2

EXPERIMENTAL

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

Drug: Insulin glargine HOE901; Drug: Insulin glargine - New formulation HOE901

Sequence 3

EXPERIMENTAL

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

Drug: Insulin glargine HOE901; Drug: Insulin glargine - New formulation HOE901

Interventions

Insulin glargine HOE901 DRUG

Pharmaceutical form:solution for injection Route of administration: subcutaneous

Also known as: Lantus®

Sequence 1; Sequence 2; Sequence 3

Insulin glargine - New formulation HOE901 DRUG

Pharmaceutical form:solution for injection Route of administration: subcutaneous

Sequence 1; Sequence 2; Sequence 3

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Investigational Site Number 392001

Fukuoka, 812-0025, Japan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2011
• First Posted: December 15, 2011
• Study Start: November 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: May 1, 2012

Record last verified: 2012-04

Locations

JP (1)