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

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ClinicalTrials.gov Identifier: NCT03244241
Recruitment Status : Recruiting
First Posted : August 9, 2017
Last Update Posted : August 9, 2017
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by (Responsible Party):
Merete Bechmann Christensen, Hvidovre University Hospital

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Insulin Degludec 100 UNT/ML [Tresiba] Phase 4

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  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : April 1, 2018
Estimated Study Completion Date : April 1, 2018

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Difference in mean daily plasma glucose between the two groups [ Time Frame: 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 :
  1. Mean number and rates of hypoglycemic events (PG ≤ 3.9 mmol/L) [ Time Frame: Duration of hospital stay, an expected average of 8 days ]
    Based on bedside PG measures and on CGM data

  2. Time spent in glycemic range [ Time Frame: Duration of hospital stay, an expected average of 8 days ]
    Based on bedside PG measures and on CGM data

  3. Time spent in hyperglycemic range [ Time Frame: Duration of hospital stay, an expected average of 8 days ]
    Based on bedside PG measures and on CGM data

  4. Length of hospital stay [ Time Frame: Duration of hospital stay, an expected average of 8 days ]
    Mean duration of hospital stay

  5. Difference in insulin dose between groups [ Time Frame: Duration of hospital stay, an expected average of 8 days ]
    Calculated as mean insulin dose during admission

  6. Number of hospital acquired infections during admission [ Time Frame: Duration of hospital stay, an expected average of 8 days ]
    Data from hospital record

  7. Number of post-discharge infections or re-admissions 1 month after discharge [ Time Frame: 1 month ]
    Data collected on follow-up 1 month after discharge



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03244241


Contacts
Contact: Merete B Christensen, MD 23811264 merete.bechmann.christensen.01@regionh.dk
Contact: Kirsten Norgaard, DMSC kirsten.noergaard@regionh.dk

Locations
Denmark
Hvidovre University Hospital Recruiting
Hvidovre, Denmark, 2650
Contact: Merete B. Christensen, MD    +4538623389    merete.bechmann.christensen.01@regionh.dk   
Sponsors and Collaborators
Merete Bechmann Christensen
Novo Nordisk A/S
Investigators
Principal Investigator: Kirsten B Norgaard, DMSC Hvidovre University Hospital

Responsible Party: Merete Bechmann Christensen, Principle investigator, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT03244241     History of Changes
Other Study ID Numbers: U1111-1177-2744
First Posted: August 9, 2017    Key Record Dates
Last Update Posted: August 9, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Keywords provided by Merete Bechmann Christensen, Hvidovre University Hospital:
Type 2 diabetes, inpatient diabetes management, basal-bolus insulin

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin degludec, insulin aspart drug combination
Insulin
Insulin Aspart
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs