Diabetes mellitus type 2 MedDRA version: 18.0 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: Toujeo
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INSULIN GLARGINE
CAS Number: 160337-95-1
Concentration unit: IU international unit(s)
Concentration type: equal
Conc
Sponsors
Medizinische Universität Graz, Universitätsklinik für Innere Medizin, Klin.Abt. für Endokrinologie und Stoffwechsel
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Informed consent obtained after being advised of the nature of the study Male or female aged =18 years Type 2 diabetes (treated with diet, oral agents, non-insulin injected anti-diabetic medicine, insulin therapy or any combination of the four) or newly diagnosed hyperglycemia which requires s.c. insulin therapy Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Type 1 diabetes, gestational diabetes Any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the patient Pregnancy Any mental condition rendering the patient incapable of giving his consent Known or suspected allergy to insulin glargine or insulin glulisine Continuous parenteral nutrition Participation in another trial which can influence the software algorithm
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the efficacy of the GlucoTab system for glycemic management using insulin glargine U300 in non-critically ill patients with type 2 diabetes at the general ward;Secondary Objective: To investigate safety, usability and further efficacy parameters of the GlucoTab system using insulin glargine U300 Hypoglycemia rates Time in target (100-140mg/dl) Glucose variability as assessed by continuous glucose monitoring Insulin doses (total, basal, bolus) ;Primary end point(s): Mean percentage of blood glucose measurements in the target range 70 to 140 mg/dl, as calculated by all premeal and bedtime glucose values measured = 24 hours after start of therapy;Timepoint(s) of evaluation of this end point: Lenght of GlucoTab treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety: • Number of hypoglycemic episodes requiring third party help • Number of blood glucose measurements per day • Number of missed blood glucose measurements per day • Number of additionally required blood glucose measurements • Insulin dose - basal, bolus and corrective insulin dose per day • Number of insulin injections per day • Number and reasons for non-performance of insulin injections per day • Relevant concomitant medication (corticosteroids, parenteral nutrition, oral hypoglycemic agents) Usability: • Adherence to the insulin dose suggestion of the GlucoTab system Efficacy: • Mean daily blood glucose as calculated by premeal and bedtime blood glucose values: Overall and per treatment day • Mean pre-breakfast blood glucose, mean pre-lunch blood glucose, mean pre-dinner blood glucose, mean bedtime blood glucose • Mean pre-enrolment blood glucose • Number and percentage of the following ranges: 0-140-140-<180 mg/dl, 180-<300 mg/dl, = 300 mg/dl ;Timepoint(s) of evaluation of this end point: Length of GlucoTab treatment | — |
Countries
Austria
Contacts
Public ContactPrincipal Investigator
Medizinische Universität Graz, Universitätsklinik für Innere Medizin, Klin.Abt. für Endokrinologie und Stoffwechsel
Outcome results
None listed