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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

NCT02910518 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2022-04-25

No results posted yet for this study

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.

Conditions

  • Type1 Diabetes Mellitus

Interventions

DRUG

Insulin glulisine (U300)

Pharmaceutical form: solution Route of administration: subcutaneous

DRUG

Insulin glulisine

Pharmaceutical form: solution Route of administration: subcutaneous

DRUG

Insulin aspart

Pharmaceutical form: solution Route of administration: intravenous/subcutaneous

DRUG

NPH insulin

Pharmaceutical form: solution Route of administration: subcutaneous

DRUG

Glucagon

Pharmaceutical form: Powder and solvent for solution for injection Route of administration: subcutaneous

DRUG

Glucose

Pharmaceutical form: solution Route of administration: intravenous

DRUG

Heparin

Pharmaceutical form: solution Route of administration: intravenous

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-17
Primary Completion
2017-05-03
Completion
2017-05-03

Countries

  • Germany

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02910518 on ClinicalTrials.gov