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A Study to Compare Pharmacokinetics and Pharmacodynamics of SAR342434 to Insulin Lispro in Subjects With Type 1 Diabetes

Primary Purpose

Type 1 Diabetes

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

SAR342434

Insulin Lispro

About this trial

This is an interventional treatment trial for Type 1 Diabetes

Eligibility Criteria

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

Inclusion criteria:

Male or female subjects with diabetes mellitus type 1 for more than one year.
Total insulin dose of < 1.2 U/kg/day.
Fasting negative serum C-peptide (< 0.3 nmol/L).
Glycohemoglobin (HbA1c) ≤ 9%.
Stable insulin regimen for at least 2 months prior to study.
Normal findings in medical history and physical examination (cardiovascular system, chest and lungs, thyroid, abdomen, nervous system, skin and mucosae, and musculo-skeletal system), vital signs, electrocardiogram (ECG) and safety lab.

Exclusion criteria:

Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic (apart from diabetes mellitus type 1), hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, or 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 headaches and/or migraine, recurrent nausea and/or vomiting (more than twice a month.
Symptomatic postural hypotension, irrespective of the decrease in blood pressure, or asymptomatic postural hypotension defined as a decrease in systolic blood pressure ≥20 mmHg within 3 minutes when changing from supine to standing position.
Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician.
Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol.
Any medication (including St John's Wort) within 14 days before inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of the medication, with the exception of insulins, 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.
Positive result on any of the following tests: hepatitis B surface (HBs Ag) antigen, anti-hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and anti HIV2 Ab.
Any history or presence of deep leg vein thrombosis or a frequent appearance of deep leg vein thrombosis in 1st 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

Sanofi Administrative Office

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Test (T)

Reference 1 (R1)

Reference 2 (R2)

Arm Description

SAR342434: single dose injection

US-approved Humalog®: single dose injection

EU-approved Humalog®: single dose injection

Outcomes

Primary Outcome Measures

Maximum plasma concentration (Cmax) of SAR342434, US-approved Humalog and EU-approved Humalog

Area under the concentration versus time curve (AUC) of SAR342434, US-approved Humalog and EU-approved Humalog

Area under the body weight standardized glucose infusion rate (GIR) versus time curve from 0 to 12 hours post administration (GIR-AUC0-12)

Secondary Outcome Measures

The fractional area under the concentration versus time curve from 0 or y to x hours post administration (INS-AUC0 or Y to X)

Time to 20% of AUC (t20%-AUC)

NS-tmax, INS-t1/2z

The fractional area under the body weight standardized GIR versus time curve from 0 or y to x hours post administration (GIR-AUC0 or Y to X)

Time to 20% of total GIR-AUC0-12h (t20%-GIR-AUC0-12h)

Maximum smoothed body weight standardized GIR (GIRmax)

Time to GIRmax (GIR-tmax)

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

Number of patients with AEs, SAEs, laboratory, vital signs and electrocardiographic abnormalities , injections site reaction assessment (ISR), and if any, hypoglycemia

Full Information

NCT ID

NCT02273258

First Posted

October 21, 2014

Last Updated

October 21, 2014

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT02273258

Brief Title

A Study to Compare Pharmacokinetics and Pharmacodynamics of SAR342434 to Insulin Lispro in Subjects With Type 1 Diabetes

Official Title

A Randomized, Double-Blind, Controlled, Single-Dose, 3-Treatment, 3-Period, 6-Sequence Crossover Study to Compare Exposure and Activity of SAR342434 to Humalog® Using the Euglycemic Clamp Technique, in Subjects With Type 1 Diabetes Mellitus

Study Type

Interventional

2. Study Status

Record Verification Date

October 2014

Overall Recruitment Status

Completed

Study Start Date

March 2013 (undefined)

Primary Completion Date

July 2013 (Actual)

Study Completion Date

July 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 compare exposure and activity of SAR342434 to US-approved and EU-approved Humalog®. Secondary Objective: To assess the safety and tolerability of SAR342434.

Detailed Description

The total study duration for a screened subject will be about 3 - 8 weeks (min-max duration, excl. screening) Screening: 2 to 28 days (D -28 to D -2) Treatment period 1 - 3: 2 days (1 overnight stay) Washout: 5 - 18 days (preferentially 7 days between consecutive dosing) End-of-study visit: 1 day between D 5 and D14 after last administration of investigational product.

6. Conditions and Keywords

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

Type 1 Diabetes

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Test (T)

Arm Type

Experimental

Arm Description

SAR342434: single dose injection

Arm Title

Reference 1 (R1)

Arm Type

Active Comparator

Arm Description

US-approved Humalog®: single dose injection

Arm Title

Reference 2 (R2)

Arm Type

Active Comparator

Arm Description

EU-approved Humalog®: single dose injection

Intervention Type

Drug

Intervention Name(s)

SAR342434

Intervention Description

Pharmaceutical form:solution Route of administration: subcutaneous

Intervention Type

Drug

Intervention Name(s)

Insulin Lispro

Intervention Description

Pharmaceutical form:solution Route of administration: subcutaneous

Intervention Type

Drug

Intervention Name(s)

Insulin Lispro

Intervention Description

Pharmaceutical form:solution Route of administration: subcutaneous

Primary Outcome Measure Information:

Title

Maximum plasma concentration (Cmax) of SAR342434, US-approved Humalog and EU-approved Humalog

Time Frame

12 hours

Title

Area under the concentration versus time curve (AUC) of SAR342434, US-approved Humalog and EU-approved Humalog

Time Frame

12 hours

Title

Area under the body weight standardized glucose infusion rate (GIR) versus time curve from 0 to 12 hours post administration (GIR-AUC0-12)

Time Frame

12 hours

Secondary Outcome Measure Information:

Title

The fractional area under the concentration versus time curve from 0 or y to x hours post administration (INS-AUC0 or Y to X)

Time Frame

12 hours

Title

Time to 20% of AUC (t20%-AUC)

Time Frame

12 hours

Title

NS-tmax, INS-t1/2z

Time Frame

12 hours

Title

The fractional area under the body weight standardized GIR versus time curve from 0 or y to x hours post administration (GIR-AUC0 or Y to X)

Time Frame

12 hours

Title

Time to 20% of total GIR-AUC0-12h (t20%-GIR-AUC0-12h)

Time Frame

12 hours

Title

Maximum smoothed body weight standardized GIR (GIRmax)

Time Frame

12 hours

Title

Time to GIRmax (GIR-tmax)

Time Frame

12 hours

Title

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

Time Frame

12 hours

Title

Number of patients with AEs, SAEs, laboratory, vital signs and electrocardiographic abnormalities , injections site reaction assessment (ISR), and if any, hypoglycemia

Time Frame

8 weeks

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 with diabetes mellitus type 1 for more than one year. Total insulin dose of < 1.2 U/kg/day. Fasting negative serum C-peptide (< 0.3 nmol/L). Glycohemoglobin (HbA1c) ≤ 9%. Stable insulin regimen for at least 2 months prior to study. Normal findings in medical history and physical examination (cardiovascular system, chest and lungs, thyroid, abdomen, nervous system, skin and mucosae, and musculo-skeletal system), vital signs, electrocardiogram (ECG) and safety lab. Exclusion criteria: Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic (apart from diabetes mellitus type 1), hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, or 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 headaches and/or migraine, recurrent nausea and/or vomiting (more than twice a month. Symptomatic postural hypotension, irrespective of the decrease in blood pressure, or asymptomatic postural hypotension defined as a decrease in systolic blood pressure ≥20 mmHg within 3 minutes when changing from supine to standing position. Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician. Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol. Any medication (including St John's Wort) within 14 days before inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of the medication, with the exception of insulins, 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. Positive result on any of the following tests: hepatitis B surface (HBs Ag) antigen, anti-hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and anti HIV2 Ab. Any history or presence of deep leg vein thrombosis or a frequent appearance of deep leg vein thrombosis in 1st 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

Sanofi Administrative Office

City

Frankfurt

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

A Study to Compare Pharmacokinetics and Pharmacodynamics of SAR342434 to Insulin Lispro in Subjects With Type 1 Diabetes

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