Type 2 Diabetes MellitusPhase 4NCT03244241
Basal-bolus Insulin Therapy Versus Standard Therapy for the Inpatient Management of Type 2 Diabetes: the IDA2 Study
A Phase 4 study testing Insulin Degludec 100 UNT/ML [Tresiba] in people with Type 2 Diabetes Mellitus, run by Merete Bechmann Christensen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Insulin Degludec 100 UNT/ML [Tresiba]
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Apr 2017to 1 Apr 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
Kirsten Norgaard, DMSC contact
Denmark1 site, 1 recruiting
- Recruiting
Hvidovre University Hospital
Hvidovre, 2650
Merete B. Christensen, MD, +4538623389, merete.bechmann.christensen.01@regionh.dk
About this 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
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.
Read the 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
- Being tested
- Insulin Degludec 100 UNT/ML [Tresiba]
- Keywords
- Type 2 diabetes, inpatient diabetes management, basal-bolus insulin
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin Degludec 100 UNT/ML [Tresiba]Drug
Basal-bolus insulin regime
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Basal-bolus insulin regime with Insulin Degludec and insulin aspart Receives: Drug: Insulin Degludec 100 UNT/ML [Tresiba] |
| Standard | No intervention | Standard treatment according to hospital guidelines with sliding scale insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Based on bedside PG measures and on CGM data
Measured: Duration of hospital stay, an expected average of 8 days
Time spent in glycemic range
Based on bedside PG measures and on CGM data
Measured: Duration of hospital stay, an expected average of 8 days
Time spent in hyperglycemic range
Based on bedside PG measures and on CGM data
Measured: Duration of hospital stay, an expected average of 8 days
Length of hospital stay
Mean duration of hospital stay
Measured: Duration of hospital stay, an expected average of 8 days
Difference in insulin dose between groups
Calculated as mean insulin dose during admission
Measured: Duration of hospital stay, an expected average of 8 days
Number of hospital acquired infections during admission
Data from hospital record
Measured: Duration of hospital stay, an expected average of 8 days
Number of post-discharge infections or re-admissions 1 month after discharge
Data collected on follow-up 1 month after discharge
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2017
- Study start1 Apr 2017
- Primary completion1 Apr 2018 (estimated)
- Study completion1 Apr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merete Bechmann Christensen
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S
- Responsible party
- Sponsor-investigator, Merete Bechmann Christensen, Hvidovre University Hospital
- Investigators
- Kirsten B Norgaard, DMSC, Principal investigator, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03244241
- Sponsor's protocol ID
- U1111-1177-2744
- Status last verified
- Aug 2017
- First submitted
- 7 Jun 2017
- Last updated
- 9 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03244241
- Acronym / sponsor ID
- U1111-1177-2744
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Type 2 diabetes, inpatient diabetes management, basal-bolus insulin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Merete Bechmann ChristensenUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 1 Apr 2018 (estimated)
- Study completion
- 1 Apr 2018 (estimated)
- First posted
- 9 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Drug: Insulin Degludec 100 UNT/ML [Tresiba]Basal-bolus insulin regime with Insulin Degludec and insulin aspart |
| Standard | No intervention | –Standard treatment according to hospital guidelines with sliding scale insulin |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulin Degludec 100 UNT/ML [Tresiba]Basal-bolus insulin regime | Drug | Intervention |
Primary outcome
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.
7 secondary outcomes
Mean number and rates of hypoglycemic events (PG ≤ 3.9 mmol/L)
Time frame: Duration of hospital stay, an expected average of 8 days
Time spent in glycemic range
Time frame: Duration of hospital stay, an expected average of 8 days
Time spent in hyperglycemic range
Time frame: Duration of hospital stay, an expected average of 8 days
Length of hospital stay
Time frame: Duration of hospital stay, an expected average of 8 days
Difference in insulin dose between groups
Time frame: Duration of hospital stay, an expected average of 8 days
Number of hospital acquired infections during admission
Time frame: Duration of hospital stay, an expected average of 8 days
Number of post-discharge infections or re-admissions 1 month after discharge
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirsten Norgaard, DMSC contact
Kirsten B Norgaard, DMSC principal investigator
Hvidovre University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Insulin Degludec 100 UNT/ML [Tresiba] in people with Type 2 Diabetes Mellitus, run by Merete Bechmann Christensen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Merete B Christensen, MD (23811264, merete.bechmann.christensen.01@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in mean daily plasma glucose between the two groups (time frame: Duration of hospital stay, an expected average of 8 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2017.