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

Type 1 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03903016
• Other study ID #: BEQ15846
• Secondary ID: 2018-003131-30U1
• Status: Completed
• Phase: Phase 1
• Start date: March 26, 2019
• Est. completion date: August 19, 2019

Study information

• Verified date: April 2022
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: August 19, 2019
• Est. primary completion date: August 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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 ß-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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Drug:
• Insulin Lispro SAR342434
Pharmaceutical form:solution for injection Route of administration: subcutaneous
• Insulin Lispro SAR342434
Pharmaceutical form:solution for injection Route of administration: subcutaneous

Locations

Country	Name	City	State
Germany	Investigational Site Number 2760001	Neuss

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of pharmacokinetc (PK) parameter:INS-Cmax	Maximum Insulin (INS) concentration	10 hours
Primary	Assessment of PK parameter :INS-AUClast -	Area under INS concentration time curve from 0 to last measurable concentration -	10 hours
Secondary	Assessment of PK parameter:INS-AUC	Area under INS concentration time curve from 0 to infinity	10 hours
Secondary	Assessment of PK parameter:INS-tmax	Time to reach INS-Cmax	10 hours
Secondary	Assessment of PK parameter:INS-t1/2z	INS terminal half life	10 hours
Secondary	Assessment of pharmacodynamic (PD) parameter:GIR-AUC0-8	Area under the Glucose Infusion Rate (GIR) time curve from 0 to 8 hours	8 hours
Secondary	Assessment of PD parameter:GIR-max	Maximum smoothed GIR	8 hours
Secondary	Assessment of PD parameter:GIR-tmax	Time to reach GIR-max	8 hours
Secondary	Duration of blood glucose control	Duration of blood glucose control at or below 105 mg/dL	8 hours
Secondary	Adverse Events	Number of participants with adverse events	Up to Day 62