Type 2 Diabetes MedDRA version: 13.1 Level: LLT Classification code 10049746 Term: Insulin-requiring type II diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: Insulin Aspart (Novorapid)
Product Name: Novorapid
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INSULIN ASPART
CAS Number: 116094-23-6
Concentration unit: IU internatio
Sponsors
Medizinische Universität 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 - 90 years (both inclusive) • Type 2 diabetes (diagnosed at least 3 months prior to study start) treated with diet, oral agents, non-insulin injected anti-diabetic medicine, insulin therapy or any combination of the four • Blood glucose in the range between 140 – 400 mg/dl (both inclusive) • Expected stay = 48 hours Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 34
Exclusion criteria
Exclusion criteria: • Hyperglycemia without known history of type 2 diabetes mellitus • Impaired renal function (serum creatinine =3.0mg/dL) • Clinically relevant hepatic disease • Presence or history of diabetic ketoacidosis • Pregnancy • Any mental condition rendering the patient incapable of giving his consent • Terminally ill patients • Participation in a trail within 3 months prior to this trail • Known or suspected allergy to insulin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of enhanced published best practice paper-based insulin titration protocol (ePBP) for glycaemic control in hospitalised patients with type 2 diabetes for the length of hospital stay, with a maximum of 21 days.;Secondary Objective: To evaluate safety and usability of ePBP for glycaemic control in hospitalised patients with type 2 diabetes, with a maximum of 21 days. To compare the efficacy of ePBP vs. standard care (SC) for glycaemic control in hospitalised patients with type 2 diabetes for the length of hospital stay, with a maximum of 21 days. ;Primary end point(s): Mean blood glucose as calculated by premeal and bedtime glucose values per treatment day ;Timepoint(s) of evaluation of this end point: At hospital discharge / transfer to other ward/department / if study period exceeds 21 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Mean daily blood glucose as calculated by blood glucose values per treatment day • Pre-enrolment blood glucose • Number of glucose measurements in target (100-140 mg/dl), hypoglycaemic (70–140-180 mg/dl, 180-<300mg/dl, =300mg/dl) • Hypoglycaemia and possible attendant clinical symptoms, hypoglycaemic episodes requiring third party help • Number of blood glucose measurements per day, number of missed glucose measurements per day • Number and reasons for additionally required blood glucose measurements • Point of time of glucose measurements per day • Insulin dose - basal, bolus and supplemental insulin dose per day • Number of insulin injections per day • Number and reasons for non-performance of insulin injections per day • Number and reason of incorrect calculated insulin dose • Adherence to the ePBP advice • Other usability parameters like workload and workflow of treatment • Number of meals per day • Relevant concomitant medication (corticosteroids, continuous parenteral nutrition) ;Timepoint(s) of evaluation of this end point: At hospital discharge / transfer to other ward/department / if study period exceeds 21 days | — |
Countries
Austria
Contacts
Public ContactClinical Research Center
Medical University of Graz
Outcome results
None listed