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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Basal-bolus Insulin Therapy With Insulin Degludec and Insulin Aspart Versus Standard Therapy for the Inpatient Management of Type 2 Diabetes: the IDA2 Study

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Insulin Degludec 100 UNT/ML [Tresiba]


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention<br>Basal-bolus insulin regime with Insulin Degludec and insulin aspart | Drug: Insulin Degludec 100 UNT/ML [Tresiba]<br>* Basal-bolus insulin regime<br>|
| No Intervention: Standard<br>Standard treatment according to hospital guidelines with sliding scale insulin | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Duration of hospital stay, an expected average of 8 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean number and rates of hypoglycemic events (PG ≤ 3.9 mmol/L) | Based on bedside PG measures and on CGM data | Duration of hospital stay, an expected average of 8 days | 
| Time spent in glycemic range | Based on bedside PG measures and on CGM data | Duration of hospital stay, an expected average of 8 days | 
| Time spent in hyperglycemic range | Based on bedside PG measures and on CGM data | Duration of hospital stay, an expected average of 8 days | 
| Length of hospital stay | Mean duration of hospital stay | Duration of hospital stay, an expected average of 8 days | 
| Difference in insulin dose between groups | Calculated as mean insulin dose during admission | Duration of hospital stay, an expected average of 8 days | 
| Number of hospital acquired infections during admission | Data from hospital record | Duration of hospital stay, an expected average of 8 days | 
| Number of post-discharge infections or re-admissions 1 month after discharge | Data collected on follow-up 1 month after discharge | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 diabetes, inpatient diabetes management, basal-bolus insulin