Basal and pre-meal insulin versus standard therapy for the inpatient manegement of type 2 diabetes: The IDA2 study

Phase 1

• Conditions: Type 2 diabetes; MedDRA version: 19.0Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2016-002910-38-DK
• Lead Sponsor: Hvidovre University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-25
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

•History of type 2 diabetes for at least 6 months
•Age 18 – 90 years
•Pre-meal plasma glucose in the range 10 – 22,2 mmol/L prior to inclusion
•Expected hospital stay longer than 4 days (after inclusion into the trial)
•Signed informed consent

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 100
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Hyperglycemia without known history of type 2 diabetes
•Type 1 diabetes mellitus
•Severely impaired renal function (eGFR = 30 mL/min/1,73 m2)
•Severe hepatic disease
•Cardiac disease defined as: Decompensated heart failure (NYHA class III-IV) and/or diagnosis of unstable angina pectoris and/or myocardial infarction within the last 6 months
•Pregnant or lactating women or fertile female patients not using chemical, hormonal or mechanical contraceptives or not in menopause (i.e. must not have had regular menstrual bleeding for at least one year)
•Planned treatment during hospital stay with intravenous glucose/ insulin for = 12 hours
•Treatment at admission or planned treatment during hospital stay with parenteral nutrition or enteral nutrition (i.e. gastroenteric tube feeding)
•Treatment at admission or planned treatment during hospital stay with high dose glucocorticoids (= 25 mg)
•History or presence of malignancy (except basal skin cancer) unless a disease-free period exceeding five years
•Presence of alcohol or drug abuse
•Inability to understand the written information or incapability to provide informed consent
•Known or suspected hypersensitivity to trial product(s) or related products.
•Other concomitant medical or psychological conditions that according to the investigator´s assessment makes the patient unsuitable for study participation
•Previous participation in this 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 and compare the efficacy and safety of basal-bolus insulin therapy using the insulin analogue, insulin degludec once daily and insulin aspart before meals versus standard therapy with sliding scale insulin in non-critical ill hospitalized patients with type 2 diabetes.;Secondary Objective: Not applicable;Primary end point(s): Difference in mean daily plasma glucose between the two groups, calculated by using the four daily pre-meal and bedside PG values per patient.;Timepoint(s) of evaluation of this end point: End of treatment