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

Merete Bechmann Christensen

Status and phase

Unknown

Phase 4

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: Insulin Degludec 100 UNT/ML [Tresiba]

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03244241

U1111-1177-2744

Details and patient eligibility

About

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.

Full description

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.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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