Basal-bolus Insulin Therapy Versus Standard Therapy for the Inpatient Management of Type 2 Diabetes: the IDA2 Study

Merete Bechmann Christensen100 enrolled

Overview

Hyperglycemia during admission is associated with increased rate of complications and longer hospital stays, thus insulin treatment is recommended for all diabetes patients with hyperglycemia. Inpatient studies of non-critically ill patients show better glycemic control with the use of basal-bolus insulin therapy compared to sliding scale insulin therapy, but increased rates of hypoglycemia. The investigators hypothesize that basal-bolus insulin therapy with a new ultra-long-action basal insulin can treat hyperglycemia more efficiently than sliding scale insulin, with few episodes of hypoglycemia.

The aim of this study is 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. The design of the trial is an open, randomized controlled trial with two parallel arms (treatment arm and control arm). Randomization is 1:1.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Type 2 Diabetes Mellitus

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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 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 (\>40 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

Outcomes

Primary Outcomes

Difference in mean daily plasma glucose between the two groups

Difference in mean daily plasma glucose between the two groups, calculated by using the four daily pre-meal and bedside PG values per patient.