Diabetes Mellitus Type 2, Hyperglycaemia
Conditions
Interventions
Trade Name: Tresiba
Product Name: Insulin Degludec
Product Code: EMA/101455/2015
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: INSULIN DEGLUDEC
CAS Number: 844439-
Sponsors
Medical University of Graz
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) 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 •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: after the end of the study | — |
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: after the end of the study | — |
Countries
Austria
Contacts
Public ContactDiabetes Trials/Outpatient Departm.
Medical University of Graz
Outcome results
None listed