Clinical trial NCT03244241: Basal-bolus Insulin Therapy Versus Standard Therapy for the Inpatient Management of Type 2 Diabetes: the IDA2 Study
Official title: Basal-bolus Insulin Therapy With Insulin Degludec and Insulin Aspart Versus Standard Therapy for the Inpatient Management of Type 2 Diabetes: the IDA2 Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 diabetes, inpatient diabetes management, basal-bolus insulin
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
Collaborators: name: Novo Nordisk A/S
First posted: 2017-08-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Difference in mean daily plasma glucose between the two groups
timeFrame: Duration of hospital stay, an expected average of 8 days
Secondary outcomes:
measure: Mean number and rates of hypoglycemic events (PG ≤ 3.9 mmol/L)
timeFrame: Duration of hospital stay, an expected average of 8 days
measure: Time spent in glycemic range
timeFrame: Duration of hospital stay, an expected average of 8 days
measure: Time spent in hyperglycemic range
timeFrame: Duration of hospital stay, an expected average of 8 days
measure: Length of hospital stay
timeFrame: Duration of hospital stay, an expected average of 8 days
measure: Difference in insulin dose between groups
timeFrame: Duration of hospital stay, an expected average of 8 days
measure: Number of hospital acquired infections during admission
timeFrame: Duration of hospital stay, an expected average of 8 days
measure: Number of post-discharge infections or re-admissions 1 month after discharge
timeFrame: 1 month
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre University Hospital
Study officials:
affiliation: Hvidovre University Hospital
name: Kirsten B Norgaard, DMSC
role: PRINCIPAL_INVESTIGATOR
References: