Evaluation of glycemic control with GlucoTab using an ultra-long acting insulin analogue (Toujeo 300)

Phase 1

Conditions: Diabetes mellitus type 2
MedDRA version: 18.0Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Registration Number: EUCTR2015-003669-27-AT

Lead Sponsor: Medizinische Universität Graz, Universitätsklinik für Innere Medizin, Klin.Abt. für Endokrinologie und Stoffwechsel

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 30

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

•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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>Hypoglycemia rates<br>Time in target (100-140mg/dl)<br>Glucose variability as assessed by continuous glucose monitoring<br>Insulin doses (total, basal, bolus)<br>;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 Outcome Measures