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

NCT ID: NCT03244241

Last Updated: 2017-08-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-01
• Study Completion Date: 2018-04-01

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.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

Basal-bolus insulin regime with Insulin Degludec and insulin aspart

Group Type: ACTIVE_COMPARATOR

Insulin Degludec 100 UNT/ML [Tresiba]

Intervention Type: DRUG

Basal-bolus insulin regime

Standard

Standard treatment according to hospital guidelines with sliding scale insulin

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Insulin Degludec 100 UNT/ML [Tresiba]

Basal-bolus insulin regime

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: collaborator

Merete Bechmann Christensen

OTHER

Sponsor Role: lead

Responsible Party

Merete Bechmann Christensen

Principle investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Kirsten B Norgaard, DMSC

Role: PRINCIPAL_INVESTIGATOR

Hvidovre University Hospital

Locations

Hvidovre University Hospital

Hvidovre, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Merete B Christensen, MD

Role: CONTACT

merete.bechmann.christensen.01@regionh.dk

23811264

Kirsten Norgaard, DMSC

Role: CONTACT

kirsten.noergaard@regionh.dk

Facility Contacts

Merete B. Christensen, MD

Role: primary

merete.bechmann.christensen.01@regionh.dk

+4538623389

Other Identifiers

U1111-1177-2744

Identifier Type: -

Identifier Source: org_study_id