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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01493115
First received: November 29, 2011
Last updated: April 30, 2012
Last verified: April 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Type 1 Diabetes Mellitus
 Drug: Insulin glargine HOE901
Drug: Insulin glargine - New formulation HOE901
 Phase 1

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Glucose infusion rate [ Time Frame: up to day 2 of each period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetic parameter : Cmax [ Time Frame: up to day 2 of each period ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameter : Tmax [ Time Frame: up to day 2 of each period ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameter : AUC [ Time Frame: up to day 2 of each period ] [ Designated as safety issue: No ]
  • Number of patients with adverse events [ Time Frame: up to day 3 of each period ] [ Designated as safety issue: Yes ]
  • Safety-related parameters including electrocardiogram, vital signs and laboratory tests [ Time Frame: up to day 3 of each period ] [ Designated as safety issue: Yes ]

Enrollment: 18
Study Start Date: November 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: Lantus®
Drug: Insulin glargine - New formulation HOE901
Pharmaceutical form:solution for injection Route of administration: subcutaneous

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

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01493115

Locations
Japan
Investigational Site Number 392001
Fukuoka-Shi, Japan, 812-0025
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01493115     History of Changes
Other Study ID Numbers: PKD12270, U1111-1120-0463
Study First Received: November 29, 2011
Last Updated: April 30, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
 Glargine
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013