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Trial record 42 of 447 for:    subcutaneous | "Diabetes Mellitus, Insulin-Dependent"

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

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ClinicalTrials.gov Identifier: NCT02910518
Recruitment Status : Completed
First Posted : September 22, 2016
Last Update Posted : June 12, 2017
Sponsor:
Information provided by (Responsible Party):
Sanofi

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Type1 Diabetes Mellitus Drug: Insulin glulisine (U300) Drug: Insulin glulisine Drug: Insulin aspart Drug: NPH insulin Drug: Glucagon Drug: Glucose Drug: Heparin Phase 1

Detailed Description:
The study duration per patient will be 18 to 62 days and will consist of a 4 to 28 days of screening period, a treatment period of 2 days, a washout between dosing occasions of 5-18 days, and follow up visit 7-14 days after last dosing.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : February 17, 2017
Actual Primary Completion Date : May 3, 2017
Actual Study Completion Date : May 3, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

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.
Drug: Insulin glulisine (U300)

Pharmaceutical form: solution

Route of administration: subcutaneous

Other Name: HMR1964 (U300)

Drug: Insulin aspart

Pharmaceutical form: solution

Route of administration: intravenous/subcutaneous

Other Name: NovoRapid®

Drug: NPH insulin

Pharmaceutical form: solution

Route of administration: subcutaneous

Other Name: Insuman® Basal Solostar®

Drug: Glucagon

Pharmaceutical form: Powder and solvent for solution for injection

Route of administration: subcutaneous

Other Name: GlucaGen® HypoKit

Drug: Glucose

Pharmaceutical form: solution

Route of administration: intravenous

Other Name: Glucose 20%

Drug: Heparin

Pharmaceutical form: solution

Route of administration: intravenous

Other Name: Heparin-Natrium-5000

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.
Drug: Insulin glulisine

Pharmaceutical form: solution

Route of administration: subcutaneous

Other Name: Apidra®

Drug: Insulin aspart

Pharmaceutical form: solution

Route of administration: intravenous/subcutaneous

Other Name: NovoRapid®

Drug: NPH insulin

Pharmaceutical form: solution

Route of administration: subcutaneous

Other Name: Insuman® Basal Solostar®

Drug: Glucagon

Pharmaceutical form: Powder and solvent for solution for injection

Route of administration: subcutaneous

Other Name: GlucaGen® HypoKit

Drug: Glucose

Pharmaceutical form: solution

Route of administration: intravenous

Other Name: Glucose 20%

Drug: Heparin

Pharmaceutical form: solution

Route of administration: intravenous

Other Name: Heparin-Natrium-5000




Primary Outcome Measures :
  1. Assessment of PK parameter: maximum observed insulin concentration [ Time Frame: 10 hours ]
  2. Assessment of PK parameter: area under the concentration time curve [ Time Frame: 10 hours ]

Secondary Outcome Measures :
  1. Assessment of PK parameter: time to reach Cmax (INS-tmax) [ Time Frame: 10 hours ]
  2. Assessment of PK parameter: terminal half-life (INS-t1/2z) [ Time Frame: 10 hours ]
  3. 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 ]
  4. Assessment of PD parameter: maximum smoothed body weight standardized GIR (GIRmax) [ Time Frame: 10 hours ]
  5. Assessment of PD parameter: time to GIRmax (GIR-tmax) [ Time Frame: 10 hours ]
  6. Duration of blood glucose control under clamp conditions - time [ Time Frame: 10 hours ]
  7. Number of patients with treatment emergent adverse events [ Time Frame: 9 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02910518


Locations
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Germany
Investigational Site Number 276001
Neuss, Germany, 41460
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi

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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT02910518     History of Changes
Other Study ID Numbers: BEQ13941
2016-001498-34 ( EudraCT Number )
U1111-1183-8636 ( Other Identifier: UTN )
First Posted: September 22, 2016    Key Record Dates
Last Update Posted: June 12, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data (IPD) and supporting clinical documents are available for request at clinicalstudydatarequest.com. While making information available we continue to protect the privacy of the participants in our clinical trials and to remove commercially confidential information (CCI). Details on Data Sharing criteria and process for requesting access can be found at this web address: clinicalstudydatarequest.com

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Insulin Aspart
Insulin, Long-Acting
Insulin degludec, insulin aspart drug combination
Insulin glulisine
Insulin, Isophane
Isophane Insulin, Human
Isophane insulin, beef
Heparin
Calcium heparin
Glucagon
Glucagon-Like Peptide 1
Hypoglycemic Agents
Physiological Effects of Drugs
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Incretins