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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03244241
• Other study ID #: U1111-1177-2744
• Status: Recruiting
• Phase: Phase 4
• First received: June 7, 2017
• Last updated: August 8, 2017
• Start date: April 1, 2017
• Est. completion date: April 1, 2018

Study information

• Verified date: August 2017
• Source: Hvidovre University Hospital
• Contact: Merete B Christensen, MD
• Phone: 23811264
• Email: merete.bechmann.christensen.01[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 1, 2018
• Est. primary completion date: April 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Insulin Degludec 100 UNT/ML [Tresiba]
Basal-bolus insulin regime

Locations

Country	Name	City	State
Denmark	Hvidovre University Hospital	Hvidovre

Sponsors (2)

Lead Sponsor	Collaborator
Merete Bechmann Christensen	Novo Nordisk A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Time spent in glycemic range	Based on bedside PG measures and on CGM data	Duration of hospital stay, an expected average of 8 days
Secondary	Time spent in hyperglycemic range	Based on bedside PG measures and on CGM data	Duration of hospital stay, an expected average of 8 days
Secondary	Length of hospital stay	Mean duration of hospital stay	Duration of hospital stay, an expected average of 8 days
Secondary	Difference in insulin dose between groups	Calculated as mean insulin dose during admission	Duration of hospital stay, an expected average of 8 days
Secondary	Number of hospital acquired infections during admission	Data from hospital record	Duration of hospital stay, an expected average of 8 days
Secondary	Number of post-discharge infections or re-admissions 1 month after discharge	Data collected on follow-up 1 month after discharge	1 month