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Repeated Dosing Study With a New Insulin Glargine Formulation and Lantus® in Patients With Type 1 Diabetes Mellitus

Primary Purpose

Type 1 Diabetes Mellitus

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

Insulin glargine HOE901

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

Male or female subjects, between 18 and 65 years of age, inclusive, with diabetes mellitus type 1 for more than one year, as defined by the American Diabetes Association
Body weight between 50.0 kg and 110.0 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; cervical/vault cap; 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 three 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.

Sites / Locations

Investigational site number 276001

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Cohort 1

Cohort 2

Arm Description

Dose Level 1

Dose Level 2

Outcomes

Primary Outcome Measures

Safety in terms of adverse and serious adverse events, vital signs, ECG, safety laboratory

Secondary Outcome Measures

Glucose infusion rate

Pharmacokinetic parameter : Cmax

Pharmacokinetic parameter : Tmax

Pharmacokinetic parameter : AUC

Full Information

NCT ID

NCT01349855

First Posted

April 15, 2011

Last Updated

May 31, 2011

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT01349855

Brief Title

Repeated Dosing Study With a New Insulin Glargine Formulation and Lantus® in Patients With Type 1 Diabetes Mellitus

Official Title

A Randomized, Double-blind, 2x2 Cross-over Euglycemic Clamp Study in Two Parallel Cohorts to Assess the Safety and Tolerability of Two Dose Levels of a New Formulation of Insulin Glargine and to Compare Its Pharmacodynamic and Pharmacokinetic Properties With 0.4 U/kg/Day Lantus® in an 8-days Multiple Dosing Regimen in Patients With Diabetes Mellitus Type 1

Study Type

Interventional

2. Study Status

Record Verification Date

May 2011

Overall Recruitment Status

Completed

Study Start Date

March 2011 (undefined)

Primary Completion Date

May 2011 (Actual)

Study Completion Date

May 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Sanofi

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Primary Objective: To assess the safety and tolerability of two dose levels of a new insulin glargine formulation in a once-daily multiple dosing regimen Secondary Objective: To compare the pharmacokinetic and pharmacodynamic properties of two dose levels of a new insulin glargine formulation with 0.4 U/kg Lantus® in a once-daily multiple dosing regimen

Detailed Description

The study duration per patient will be 33 to 68 days including 2 treatment periods of 10 days each separated by a wash-out period of 7-21 days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 1 Diabetes Mellitus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cohort 1

Arm Type

Experimental

Arm Description

Dose Level 1

Arm Title

Cohort 2

Arm Type

Experimental

Arm Description

Dose Level 2

Intervention Type

Drug

Intervention Name(s)

Insulin glargine HOE901

Intervention Description

Pharmaceutical form:solution for injection: new formulation and marketed formulation Route of administration: subcutaneous

Primary Outcome Measure Information:

Title

Safety in terms of adverse and serious adverse events, vital signs, ECG, safety laboratory

Time Frame

up to day 10 of each period

Secondary Outcome Measure Information:

Title

Glucose infusion rate

Time Frame

up to day 10 of each period

Title

Pharmacokinetic parameter : Cmax

Time Frame

up to day 10 of each period

Title

Pharmacokinetic parameter : Tmax

Time Frame

up to day 10 of each period

Title

Pharmacokinetic parameter : AUC

Time Frame

up to day 10 of each period

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: Male or female subjects, between 18 and 65 years of age, inclusive, with diabetes mellitus type 1 for more than one year, as defined by the American Diabetes Association Body weight between 50.0 kg and 110.0 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; cervical/vault cap; 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 three 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Sciences & Operations

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Investigational site number 276001

City

Neuss

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

25150159

Citation

Becker RH, Dahmen R, Bergmann K, Lehmann A, Jax T, Heise T. New insulin glargine 300 Units . mL-1 provides a more even activity profile and prolonged glycemic control at steady state compared with insulin glargine 100 Units . mL-1. Diabetes Care. 2015 Apr;38(4):637-43. doi: 10.2337/dc14-0006. Epub 2014 Aug 22.

Results Reference

derived

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Repeated Dosing Study With a New Insulin Glargine Formulation and Lantus® in Patients With Type 1 Diabetes Mellitus

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