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

Phase 4

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Insulin Degludec 100 UNT/ML [Tresiba]

• Registration Number: NCT03244241
• Lead Sponsor: Merete Bechmann Christensen

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.

Study Timeline

• Study Start: 2017-04-01
• Study First Submitted: 2017-06-07
• Status Verified: 2017-08
• Study First Submitted QC: 2017-08-08
• Last Update Submitted: 2017-08-08
• Study First Posted: 2017-08-09
• Last Update Posted: 2017-08-09
• Primary Completion: 2018-04-01
• Study Completion: 2018-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• 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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Insulin Degludec 100 UNT/ML [Tresiba]	Basal-bolus insulin regime with Insulin Degludec and insulin aspart

Primary Outcome Measures

Name	Time	Method
Difference in mean daily plasma glucose between the two groups	Duration of hospital stay, an expected average of 8 days	Difference in mean daily plasma glucose between the two groups, calculated by using the four daily pre-meal and bedside PG values per patient.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hvidovre University Hospital; 🇩🇰 Hvidovre, Denmark