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Euglycemic Clamp Study Comparing Two New Insulin Glargine Formulations in Subjects With Type 1 Diabetes Mellitus

Primary Purpose

Type1 Diabetes

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

Insulin glargine new formulation HOE901

About this trial

This is an interventional treatment trial for Type1 Diabetes

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria :

Male or female subjects, between 18 and 64 years of age, inclusive, with diabetes mellitus type 1 for more than one year
Total insulin dose of < 1.2 U/kg/day
Minimum usual basal insulin dose ≥ 0.2 U/kg/day
Body weight between 50.0 kg and 110.0 kg, Body Mass Index between 18.5 and 30.0 kg/m2 inclusive
Fasting negative serum C-peptide (< 0.3 nmol/L)
Glycohemoglobin (HbA1c) ≤ 75 mmol/mol [≤ 9.0%]
Stable insulin regimen for at least 2 months prior to inclusion in study
Certified as otherwise healthy for Type-1 Diabetes mellitus patient
Laboratory parameters within the normal range
Women of childbearing potential with negative pregnancy test and use of a highly effective contraceptive method or women with confirmed postmenopausal status

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
Frequent severe headaches and / or migraine, recurrent nausea and / or vomiting (more than twice a month)
Symptomatic hypotension (whatever the decrease in blood pressure), or asymptomatic postural hypotension defined by a decrease in systolic blood pressure equal to or greater than 20 mmHg within three minutes when changing from the supine to the standing position
Presence or history of a drug allergy or clinically significant allergic disease according to the Investigator's judgment
Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol
Presence or history of drug or alcohol abuse (alcohol consumption > 40 grams / day)
If female, pregnancy (defined as positive Beta Human Chorionic Gonadotropin test), breast-feeding
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

Insulin glargine new formulation (test T formulation)

Insulin glargine new formulation (reference R formulation)

Arm Description

Once daily for 6 days

Outcomes

Primary Outcome Measures

Area under the serum insulin concentration curve within 24 hours (INS-AUC0-24) after dosing on Day 6

Secondary Outcome Measures

Maximum insulin concentration (INS-Cmax)

Time to INS-Cmax (INS-tmax)

Time to reach 50% of INS-AUC0-24 (T50%-INS-AUC0-24)

Area under the body-weight-standardized Glucose Infusion Rate (GIR) within 24 hours (GIR-AUC0-24h) after dosing on Day 6 during the clamp

Maximum smoothed body weight standardized glucose infusion rate (GIRmax)

Time to GIRmax (GIR-Tmax)

Time to reach at least 50% of GIR-AUC0-24 (T50%-GIR-AUC0-24)

Duration of blood glucose control (time to elevation of smoothed blood glucose profile above clamp level and to elevation above different prespecified blood glucose levels)

Safety as measured by adverse events/serious adverse events, ohypoglycemia events, physical examinations, clinical laboratory, electrocardiograms, vital signs, injection site reactions and anti-insulin antibodies.

Full Information

NCT ID

NCT01838083

First Posted

April 16, 2013

Last Updated

August 9, 2013

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT01838083

Brief Title

Euglycemic Clamp Study Comparing Two New Insulin Glargine Formulations in Subjects With Type 1 Diabetes Mellitus

Official Title

A Double-blind, Randomized, Two-treatment Crossover Bioequivalence Study Comparing Two New Insulin Glargine Formulations Using the Euglycemic Clamp Technique in Subjects With Type 1 Diabetes Mellitus

Study Type

Interventional

2. Study Status

Record Verification Date

August 2013

Overall Recruitment Status

Completed

Study Start Date

April 2013 (undefined)

Primary Completion Date

August 2013 (Actual)

Study Completion Date

August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Primary Objective: To demonstrate equivalence in exposure to insulin glargine given as test formulation T and reference formulation R in steady state conditions after 6 once-daily subcutaneous (SC) doses Secondary Objective: To assess relative Pharmacodynamic activity of the insulin glargine test formulation T to the insulin glargine reference formulation R in steady state conditions after 6 once-daily SC doses To assess the safety and tolerability of the test and reference formulations of two new insulin glargine formulations

Detailed Description

Total study duration per subject: 29 to 64 days including screening visit Duration of each part of the study for one subject: Screening: 3 to 21 days before 1st dosing (Day -21 to Day -3) Treatment Period 1 and 2: 8 days (dosing on 6 days) Washout between last/1st dosing days of the treatment periods: 7-21 days (preferentially 7 days) End-of-Study Visit: 7-10 days after last dosing

6. Conditions and Keywords

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

Type1 Diabetes

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Insulin glargine new formulation (test T formulation)

Arm Type

Experimental

Arm Description

Once daily for 6 days

Arm Title

Insulin glargine new formulation (reference R formulation)

Arm Type

Experimental

Arm Description

Once daily for 6 days

Intervention Type

Drug

Intervention Name(s)

Insulin glargine new formulation HOE901

Intervention Description

Pharmaceutical form: solution Route of administration: subcutaneous

Primary Outcome Measure Information:

Title

Area under the serum insulin concentration curve within 24 hours (INS-AUC0-24) after dosing on Day 6

Time Frame

24-hours (D6 to D7)

Secondary Outcome Measure Information:

Title

Maximum insulin concentration (INS-Cmax)

Time Frame

24-hours (D6 to D7)

Title

Time to INS-Cmax (INS-tmax)

Time Frame

24-hours (D6 to D7)

Title

Time to reach 50% of INS-AUC0-24 (T50%-INS-AUC0-24)

Time Frame

24-hours (D6 to D7)

Title

Area under the body-weight-standardized Glucose Infusion Rate (GIR) within 24 hours (GIR-AUC0-24h) after dosing on Day 6 during the clamp

Time Frame

24-hours (D6 to D7)

Title

Maximum smoothed body weight standardized glucose infusion rate (GIRmax)

Time Frame

24-hours (D6 to D7)

Title

Time to GIRmax (GIR-Tmax)

Time Frame

24-hours (D6 to D7)

Title

Time to reach at least 50% of GIR-AUC0-24 (T50%-GIR-AUC0-24)

Time Frame

24-hours (D6 to D7)

Title

Duration of blood glucose control (time to elevation of smoothed blood glucose profile above clamp level and to elevation above different prespecified blood glucose levels)

Time Frame

24-hours (D6 to D7)

Title

Time Frame

up to 9 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria : Male or female subjects, between 18 and 64 years of age, inclusive, with diabetes mellitus type 1 for more than one year Total insulin dose of < 1.2 U/kg/day Minimum usual basal insulin dose ≥ 0.2 U/kg/day Body weight between 50.0 kg and 110.0 kg, Body Mass Index between 18.5 and 30.0 kg/m2 inclusive Fasting negative serum C-peptide (< 0.3 nmol/L) Glycohemoglobin (HbA1c) ≤ 75 mmol/mol [≤ 9.0%] Stable insulin regimen for at least 2 months prior to inclusion in study Certified as otherwise healthy for Type-1 Diabetes mellitus patient Laboratory parameters within the normal range Women of childbearing potential with negative pregnancy test and use of a highly effective contraceptive method or women with confirmed postmenopausal status 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 Frequent severe headaches and / or migraine, recurrent nausea and / or vomiting (more than twice a month) Symptomatic hypotension (whatever the decrease in blood pressure), or asymptomatic postural hypotension defined by a decrease in systolic blood pressure equal to or greater than 20 mmHg within three minutes when changing from the supine to the standing position Presence or history of a drug allergy or clinically significant allergic disease according to the Investigator's judgment Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol Presence or history of drug or alcohol abuse (alcohol consumption > 40 grams / day) If female, pregnancy (defined as positive Beta Human Chorionic Gonadotropin test), breast-feeding 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

ZIP/Postal Code

41460

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

Euglycemic Clamp Study Comparing Two New Insulin Glargine Formulations in Subjects With Type 1 Diabetes Mellitus

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