Pilot study to evaluate glycemic control with GlucoTab using an ultra-long acting insulin analogue in non-critically ill patients with type 2 diabetes at the genaral ward - GlucoTab_Degludec

Phase 1

• Conditions: Diabetes Mellitus Type 2, Hyperglycaemia; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2018-002646-36-AT
• Lead Sponsor: Medical University of Graz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-08-10
• Last Update Posted: 21 December 2021

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) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

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
•continuous subcutaneous insulin infusion (CSII)
•hyperglycaemic episodes (ketoacidosis, hyperosmolar state) if they require intravenous insulin therapy
•Pregnancy
•Any mental condition rendering the patient incapable of giving his consent
•Known or suspected allergy to insulin degludec or insulin aspart
•Continuous parenteral nutrition
•Participation in another trial which can influence outcome of the trial

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 degludec 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 degludec<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: after the end of the study