Clinical trial NCT03903016: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 1 Diabetes
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2019-04-04
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Assessment of pharmacokinetc (PK) parameter:INS-Cmax
timeFrame: 10 hours
measure: Assessment of PK parameter :INS-AUClast -
timeFrame: 10 hours
Secondary outcomes:
measure: Assessment of PK parameter:INS-AUC
timeFrame: 10 hours
measure: Assessment of PK parameter:INS-tmax
timeFrame: 10 hours
measure: Assessment of PK parameter:INS-t1/2z
timeFrame: 10 hours
measure: Assessment of pharmacodynamic (PD) parameter:GIR-AUC0-8
timeFrame: 8 hours
measure: Assessment of PD parameter:GIR-max
timeFrame: 8 hours
measure: Assessment of PD parameter:GIR-tmax
timeFrame: 8 hours
measure: Duration of blood glucose control
timeFrame: 8 hours
measure: Adverse Events
timeFrame: Up to Day 62
Other outcomes:
Locations:
city: Neuss
country: Germany
facility: Investigational Site Number 2760001
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: