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

NCT03244241 | Unknown Phase 4 DMC

• 1 other identifier: U1111-1177-2744
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 diabetes, inpatient diabetes management, basal-bolus insulin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Mean number and rates of hypoglycemic events (PG ≤ 3.9 mmol/L)

  Duration of hospital stay, an expected average of 8 days

• Time spent in glycemic range

  Duration of hospital stay, an expected average of 8 days

• Time spent in hyperglycemic range

  Duration of hospital stay, an expected average of 8 days

• Length of hospital stay

  Duration of hospital stay, an expected average of 8 days

• Difference in insulin dose between groups

  Duration of hospital stay, an expected average of 8 days

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Basal-bolus insulin regime with Insulin Degludec and insulin aspart

Drug: Insulin Degludec 100 UNT/ML [Tresiba]

Standard

NO INTERVENTION

Standard treatment according to hospital guidelines with sliding scale insulin

Interventions

Insulin Degludec 100 UNT/ML [Tresiba] DRUG

Basal-bolus insulin regime

Intervention

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• History of type 2 diabetes for at least 6 months
• Age 18 - 90 years
• Expected hospital stay longer than 4 days

You may not qualify if:

• 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

Sponsors & Collaborators

• Merete Bechmann Christensen: lead
• Novo Nordisk A/S: collaborator

Study Sites (1)

Hvidovre University Hospital

Hvidovre, 2650, Denmark

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

insulin degludec

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Kirsten B Norgaard, DMSC

  Hvidovre University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Merete B Christensen, MD

CONTACT

23811264; merete.bechmann.christensen.01@regionh.dk

Kirsten Norgaard, DMSC

CONTACT

kirsten.noergaard@regionh.dk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: June 7, 2017
• First Posted: August 9, 2017
• Study Start: April 1, 2017
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: August 9, 2017

Record last verified: 2017-08

Locations

DK (1)