- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02910518
A Study to Demonstrate Bioequivalence Between Insulin Glulisine U300 and Insulin Glulisine U100 After a Single Subcutaneous Dose Using the Euglycemic Clamp Technique, in Patients With Type 1 Diabetes Mellitus
A Randomized, Double-blind, Single-dose, 2-Treatment, 2-Period, 2-Sequence Crossover Bioequivalence Study Comparing Two Formulations of Insulin Glulisine (Insulin Glulisine 300 Units/mL Versus Insulin Glulisine 100 Units/mL Marketed as Apidra® 100 Units/mL) Using the Euglycemic Clamp Technique, in Patients With Type 1 Diabetes Mellitus
Primary Objective:
To demonstrate bioequivalence between insulin glulisine given as 300 Units/mL test formulation and insulin glulisine 100 Units/mL reference formulation after a single subcutaneous (SC) dose.
Secondary Objectives:
- To assess the pharmacodynamic (PD) profiles and further pharmacokinetic (PK) characteristics of insulin glulisine U300 in comparison to insulin glulisine U100 after a single SC dose.
- To assess safety and tolerability of the test and the reference formulation of insulin glulisine.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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-
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Neuss, Germany, 41460
- Investigational Site Number 276001
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria :
- Male or female subjects with type 1 diabetes mellitus (T1DM) for more than 1 year.
- Total insulin dose of <1.2 U/kg/day.
- Fasting negative serum C-peptide (<0.30 nmol/L).
- Glycohemoglobin at screening (HbA1c) ≤9%.
- Subjects with anti-insulin antibody titer at screening ≤30.0 kU/L.
- 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 musculoskeletal system), vital signs, electrocardiogram (ECG), and safety laboratory.
Exclusion criteria:
- Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic (apart from T1DM), 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 or any history or presence of heparin induced thrombocytopenia Type II (HIT-type II).
- 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 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 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 medicine containing St John's Wort) within 14 days before inclusion (for systemic glucocorticoids within 3 months) or within 5 times the elimination half-life or PD half-life of the medication, with the exception of insulin, stable treatment (at least 2 months) with thyroid hormones, lipid-lowering and antihypertensive drugs and if female with the exception of hormonal contraception or menopausal hormone replacement therapy.
- Positive reaction to 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).
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Insulin glulisine (U300) - Test formulation
Insulin glulisine (U300) will be given as a single subcutaneous (SC) dose on Day 1 of each period under fasting conditions according to the random list and assigned sequence.
Glucose, insulin aspart (IV) and heparin will be used for clamp procedure.
NPH insulin (if necessary) and insulin aspart (SC) will be handed out at screening to change insulin regimen and glucagon at Day 1 to treat cases of severe hypoglycemia.
|
Pharmaceutical form: solution Route of administration: subcutaneous
Other Names:
Pharmaceutical form: solution Route of administration: intravenous/subcutaneous
Other Names:
Pharmaceutical form: solution Route of administration: subcutaneous
Other Names:
Pharmaceutical form: Powder and solvent for solution for injection Route of administration: subcutaneous
Other Names:
Pharmaceutical form: solution Route of administration: intravenous
Other Names:
Pharmaceutical form: solution Route of administration: intravenous
Other Names:
|
Active Comparator: Insulin glulisine - Reference formulation
Insulin glulisine (U100) will be given as a single SC dose on Day 1 of each period under fasting conditions according to the random list and assigned sequence.
Glucose, insulin aspart (IV) and heparin will be used for clamp procedure.
NPH insulin (if necessary) and insulin aspart (SC) will be handed out at screening to change insulin regimen and glucagon at Day 1 to treat cases of severe hypoglycemia.
|
Pharmaceutical form: solution Route of administration: intravenous/subcutaneous
Other Names:
Pharmaceutical form: solution Route of administration: subcutaneous
Other Names:
Pharmaceutical form: Powder and solvent for solution for injection Route of administration: subcutaneous
Other Names:
Pharmaceutical form: solution Route of administration: intravenous
Other Names:
Pharmaceutical form: solution Route of administration: intravenous
Other Names:
Pharmaceutical form: solution Route of administration: subcutaneous
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Assessment of PK parameter: maximum observed insulin concentration
Time Frame: 10 hours
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10 hours
|
Assessment of PK parameter: area under the concentration time curve
Time Frame: 10 hours
|
10 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Assessment of PK parameter: time to reach Cmax (INS-tmax)
Time Frame: 10 hours
|
10 hours
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Assessment of PK parameter: terminal half-life (INS-t1/2z)
Time Frame: 10 hours
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10 hours
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Assessment of PD parameter: area under the body weight standardized glucose infusion rate (GIR) versus time curve from 0 to 10 hours (GIR-AUC0-10)
Time Frame: 10 hours
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10 hours
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Assessment of PD parameter: maximum smoothed body weight standardized GIR (GIRmax)
Time Frame: 10 hours
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10 hours
|
Assessment of PD parameter: time to GIRmax (GIR-tmax)
Time Frame: 10 hours
|
10 hours
|
Duration of blood glucose control under clamp conditions - time
Time Frame: 10 hours
|
10 hours
|
Number of patients with treatment emergent adverse events
Time Frame: 9 weeks
|
9 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Immune System Diseases
- Autoimmune Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 1
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Gastrointestinal Agents
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Anticoagulants
- Insulin
- Insulin, Globin Zinc
- Insulin Aspart
- Heparin
- Glucagon
- Calcium heparin
- Insulin glulisine
- Insulin, Isophane
- Isophane Insulin, Human
- Isophane insulin, beef
Other Study ID Numbers
- BEQ13941
- 2016-001498-34 (EudraCT Number)
- U1111-1183-8636 (Other Identifier: UTN)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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