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

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

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.

Study Overview

• Status: Unknown
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: Insulin Degludec 100 UNT/ML [Tresiba]

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Hvidovre, Denmark, 2650
    • Recruiting
    • Hvidovre University Hospital
    • Contact: Merete B. Christensen, MD; Phone Number: +4538623389; Email: merete.bechmann.christensen.01@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Merete Bechmann Christensen
• Collaborators: Novo Nordisk A/S
• Investigators: Principal Investigator: Kirsten B Norgaard, DMSC, Hvidovre University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Anticipated): April 1, 2018
• Study Completion (Anticipated): April 1, 2018

Study Registration Dates

• First Submitted: June 7, 2017
• First Submitted That Met QC Criteria: August 8, 2017
• First Posted (Actual): August 9, 2017

Study Record Updates

• Last Update Posted (Actual): August 9, 2017
• Last Update Submitted That Met QC Criteria: August 8, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Type 2 diabetes, inpatient diabetes management, basal-bolus insulin
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID Numbers: U1111-1177-2744

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No