Basal-bolus Insulin Therapy Versus Standard Therapy for t... | NCT03244241

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

NCT03244241

Sponsor

Merete Bechmann Christensen

Status

Unknown status

Last Update Posted

Aug 9, 2017Actual

Enrollment

100Estimated

Phase

Phase 4

Conditions

Type 2 Diabetes Mellitus

Interventions

Insulin Degludec 100 UNT/ML [Tresiba]

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2017Actual

Primary Completion Date

Apr 1, 2018Estimated

Completion Date

Apr 1, 2018Estimated

First Submitted Date

Jun 7, 2017

First Submission Date that Met QC Criteria

Aug 8, 2017

First Posted Date

Aug 9, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 8, 2017

Last Update Posted Date

Aug 9, 2017Actual

Name	Class
Novo Nordisk A/S	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Insulin Degludec 100 UNT/ML [Tresiba]	Drug	Basal-bolus insulin regime	Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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
Time spent in glycemic range

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Merete B Christensen, MD	Contact	23811264		merete.bechmann.christensen.01@regionh.dk
Kirsten Norgaard, DMSC	Contact			kirsten.noergaard@regionh.dk

Overall Officials

Name	Affiliation	Role
Kirsten B Norgaard, DMSC	Hvidovre University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hvidovre University Hospital	Recruiting	Hvidovre		2650	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided