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A Bioequivalence Study Comparing Two Different Strengths Formulations of Insulin Lispro in Patients With Type 1 Diabetes

Primary Purpose

Type 1 Diabetes

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

Insulin Lispro SAR342434

About this trial

This is an interventional treatment trial for Type 1 Diabetes

Eligibility Criteria

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

Inclusion criteria :

Male or female patients, between 18 and 64 years of age, inclusive, with diabetes mellitus type 1 for more than one year
Total insulin dose of <1.0 U/kg/day
Fasting serum C-peptide <0.30 nmol/L at screening
Glycohemoglobin (HbA1c) ≤75 mmol/mol (≤9%) at screening
Stable insulin regimen for at least 2 months prior to study (day of insulin regimen switch, with respect to safety of the patient and scientific integrity of the study).
Patients with anti-insulin antibody titer at screening ≤ 30.0 kU/L
Body weight between 50.0 kg and 100.0 kg, inclusive, il male , and between 40.0 and 90.0 kg, inclusive, if female, Body Mass Index between 18 and 30.0 kg/m², inclusive

Exclusion criteria:

Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness or any history or presence of HIT-type II (heparin induced thrombocytopenia Type II)
More than 1 episode of severe hypoglycemia resulting in coma/seizures or requiring assistance of another person, and/or hospitalization for diabetic ketoacidosis in the last 6 months before screening visit.
Frequent headaches and/or migraine, recurrent nausea and/or vomiting (for vomiting only, 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
If female, pregnancy (defined as positive β-HCG blood test), breast-feeding

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 2760001

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Test (T)

Reference (R)

Arm Description

Insulin Lispro (SAR342434), 200 Units/ml, single dose on day 1 of each period

Insulin Lispro Sanofi® ,100 Units/ml, single dose on day 1 of each period

Outcomes

Primary Outcome Measures

Assessment of pharmacokinetc (PK) parameter:INS-Cmax

Maximum Insulin (INS) concentration

Assessment of PK parameter :INS-AUClast -

Area under INS concentration time curve from 0 to last measurable concentration -

Secondary Outcome Measures

Assessment of PK parameter:INS-AUC

Area under INS concentration time curve from 0 to infinity

Assessment of PK parameter:INS-tmax

Time to reach INS-Cmax

Assessment of PK parameter:INS-t1/2z

INS terminal half life

Assessment of pharmacodynamic (PD) parameter:GIR-AUC0-8

Area under the Glucose Infusion Rate (GIR) time curve from 0 to 8 hours

Assessment of PD parameter:GIR-max

Maximum smoothed GIR

Assessment of PD parameter:GIR-tmax

Time to reach GIR-max

Duration of blood glucose control

Duration of blood glucose control at or below 105 mg/dL

Adverse Events

Number of participants with adverse events

Full Information

NCT ID

NCT03903016

First Posted

April 3, 2019

Last Updated

April 21, 2022

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT03903016

Brief Title

A Bioequivalence Study Comparing Two Different Strengths Formulations of Insulin Lispro in Patients With Type 1 Diabetes

Official Title

A Randomized, Double-blind, Single-dose, 2-treatment, 2-period, 2-sequence Crossover Bioequivalence Study Comparing Two Different Strengths Formulations of Insulin Lispro Using the Euglycemic Clamp Technique, in Patients With Type 1 Diabetes Mellitus

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Completed

Study Start Date

March 26, 2019 (Actual)

Primary Completion Date

August 19, 2019 (Actual)

Study Completion Date

August 19, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

Primary Objective: To demonstrate bioequivalence between insulin lispro given as SAR342434, 200 Units/ml test formulation (T) and insulin lispro 100 Units/ml reference formulation (R) after a single subcutaneous (SC) dose Secondary Objectives: To assess the pharmacodynamic profiles and further pharmacokinetic characteristics of the test formulation (T) in comparison to the reference formulation (R) after a single SC dose To assess the safety and tolerability of the test and the reference formulation of insulin lispro

Detailed Description

Study duration per participant is approximately 62 days including a screening period up to 28 days before first dose, 2 periods of 2 days, a wash out period of 5 to 18 days (preferred7 days) and an end of study visit 7 to 14 days after the last dose

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

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

90 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Test (T)

Arm Type

Experimental

Arm Description

Insulin Lispro (SAR342434), 200 Units/ml, single dose on day 1 of each period

Arm Title

Reference (R)

Arm Type

Active Comparator

Arm Description

Insulin Lispro Sanofi® ,100 Units/ml, single dose on day 1 of each period

Intervention Type

Drug

Intervention Name(s)

Insulin Lispro SAR342434

Intervention Description

Pharmaceutical form:solution for injection Route of administration: subcutaneous

Intervention Type

Drug

Intervention Name(s)

Insulin Lispro SAR342434

Other Intervention Name(s)

Insulin lispro Sanofi®

Intervention Description

Pharmaceutical form:solution for injection Route of administration: subcutaneous

Primary Outcome Measure Information:

Title

Assessment of pharmacokinetc (PK) parameter:INS-Cmax

Description

Maximum Insulin (INS) concentration

Time Frame

10 hours

Title

Assessment of PK parameter :INS-AUClast -

Description

Area under INS concentration time curve from 0 to last measurable concentration -

Time Frame

10 hours

Secondary Outcome Measure Information:

Title

Assessment of PK parameter:INS-AUC

Description

Area under INS concentration time curve from 0 to infinity

Time Frame

10 hours

Title

Assessment of PK parameter:INS-tmax

Description

Time to reach INS-Cmax

Time Frame

10 hours

Title

Assessment of PK parameter:INS-t1/2z

Description

INS terminal half life

Time Frame

10 hours

Title

Assessment of pharmacodynamic (PD) parameter:GIR-AUC0-8

Description

Area under the Glucose Infusion Rate (GIR) time curve from 0 to 8 hours

Time Frame

8 hours

Title

Assessment of PD parameter:GIR-max

Description

Maximum smoothed GIR

Time Frame

8 hours

Title

Assessment of PD parameter:GIR-tmax

Description

Time to reach GIR-max

Time Frame

8 hours

Title

Duration of blood glucose control

Description

Duration of blood glucose control at or below 105 mg/dL

Time Frame

8 hours

Title

Adverse Events

Description

Number of participants with adverse events

Time Frame

Up to Day 62

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 patients, between 18 and 64 years of age, inclusive, with diabetes mellitus type 1 for more than one year Total insulin dose of <1.0 U/kg/day Fasting serum C-peptide <0.30 nmol/L at screening Glycohemoglobin (HbA1c) ≤75 mmol/mol (≤9%) at screening Stable insulin regimen for at least 2 months prior to study (day of insulin regimen switch, with respect to safety of the patient and scientific integrity of the study). Patients with anti-insulin antibody titer at screening ≤ 30.0 kU/L Body weight between 50.0 kg and 100.0 kg, inclusive, il male , and between 40.0 and 90.0 kg, inclusive, if female, Body Mass Index between 18 and 30.0 kg/m², inclusive Exclusion criteria: Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness or any history or presence of HIT-type II (heparin induced thrombocytopenia Type II) More than 1 episode of severe hypoglycemia resulting in coma/seizures or requiring assistance of another person, and/or hospitalization for diabetic ketoacidosis in the last 6 months before screening visit. Frequent headaches and/or migraine, recurrent nausea and/or vomiting (for vomiting only, 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 If female, pregnancy (defined as positive β-HCG blood test), breast-feeding 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 2760001

City

Neuss

ZIP/Postal Code

41460

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Learn more about this trial

A Bioequivalence Study Comparing Two Different Strengths Formulations of Insulin Lispro in Patients With Type 1 Diabetes

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