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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Unknown status
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Insulin Degludec 100 UNT/ML [Tresiba]
Sponsored by
Merete Bechmann Christensen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Type 2 diabetes, inpatient diabetes management, basal-bolus insulin

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hvidovre University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Intervention

Standard

Arm Description

Basal-bolus insulin regime with Insulin Degludec and insulin aspart

Standard treatment according to hospital guidelines with sliding scale insulin

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Mean number and rates of hypoglycemic events (PG ≤ 3.9 mmol/L)
Based on bedside PG measures and on CGM data
Time spent in glycemic range
Based on bedside PG measures and on CGM data
Time spent in hyperglycemic range
Based on bedside PG measures and on CGM data
Length of hospital stay
Mean duration of hospital stay
Difference in insulin dose between groups
Calculated as mean insulin dose during admission
Number of hospital acquired infections during admission
Data from hospital record
Number of post-discharge infections or re-admissions 1 month after discharge
Data collected on follow-up 1 month after discharge

Full Information

First Posted
June 7, 2017
Last Updated
August 8, 2017
Sponsor
Merete Bechmann Christensen
Collaborators
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT03244241
Brief Title
Basal-bolus Insulin Therapy Versus Standard Therapy for the Inpatient Management of Type 2 Diabetes: the IDA2 Study
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
April 1, 2018 (Anticipated)
Study Completion Date
April 1, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Merete Bechmann Christensen
Collaborators
Novo Nordisk A/S

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Type 2 diabetes, inpatient diabetes management, basal-bolus insulin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
Basal-bolus insulin regime with Insulin Degludec and insulin aspart
Arm Title
Standard
Arm Type
No Intervention
Arm Description
Standard treatment according to hospital guidelines with sliding scale insulin
Intervention Type
Drug
Intervention Name(s)
Insulin Degludec 100 UNT/ML [Tresiba]
Intervention Description
Basal-bolus insulin regime
Primary Outcome Measure Information:
Title
Difference in mean daily plasma glucose between the two groups
Description
Difference in mean daily plasma glucose between the two groups, calculated by using the four daily pre-meal and bedside PG values per patient.
Time Frame
Duration of hospital stay, an expected average of 8 days
Secondary Outcome Measure Information:
Title
Mean number and rates of hypoglycemic events (PG ≤ 3.9 mmol/L)
Description
Based on bedside PG measures and on CGM data
Time Frame
Duration of hospital stay, an expected average of 8 days
Title
Time spent in glycemic range
Description
Based on bedside PG measures and on CGM data
Time Frame
Duration of hospital stay, an expected average of 8 days
Title
Time spent in hyperglycemic range
Description
Based on bedside PG measures and on CGM data
Time Frame
Duration of hospital stay, an expected average of 8 days
Title
Length of hospital stay
Description
Mean duration of hospital stay
Time Frame
Duration of hospital stay, an expected average of 8 days
Title
Difference in insulin dose between groups
Description
Calculated as mean insulin dose during admission
Time Frame
Duration of hospital stay, an expected average of 8 days
Title
Number of hospital acquired infections during admission
Description
Data from hospital record
Time Frame
Duration of hospital stay, an expected average of 8 days
Title
Number of post-discharge infections or re-admissions 1 month after discharge
Description
Data collected on follow-up 1 month after discharge
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Merete B Christensen, MD
Phone
23811264
Email
merete.bechmann.christensen.01@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Kirsten Norgaard, DMSC
Email
kirsten.noergaard@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kirsten B Norgaard, DMSC
Organizational Affiliation
Hvidovre University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hvidovre University Hospital
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Merete B. Christensen, MD
Phone
+4538623389
Email
merete.bechmann.christensen.01@regionh.dk

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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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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