Type 2 Diabetes MellitusEASY-1NCT03258268
Easy Diabetes Treatment Study 1
A study of Type 2 Diabetes Mellitus, run by Läkarexpressen AB at 3 sites in Sweden.
Trial summary
A 26-week, multicenter, parallel two-arm, randomized controlled trial of the glycemic outcomes of individualized treatment support in patients with type 2 diabetes. The primary objective of the trial is to confirm the superiority of standard of care with EASY DSS versus standard of care without EASY DSS in terms of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 311 participants
- Where
- 3 sitesSweden
- Study dates
- 7 Aug 2017to 19 Dec 2019
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
- ≥ 18 years of age at the time of signing informed consent
- Type 2 diabetes (diagnosed clinically) ≥ 6 months prior to screening
- HbA1c ≥ 7.0 [58 mmol/mol] by central laboratory analysis
- Stable daily treatment with any single antidiabetic drug or any combination of antidiabetic drugs for at least 90 days prior to screening (dose adjustment ±10% of insulin dose and temporary dose correction because of e.g. infection are allowed)
Who cannot join
- Previous participation in this trial. Participation is defined as informed consent.
- Currently participating in other clinical trials for diabetes
- Type 1 diabetes diagnosed clinically and/or by the presence of diabetes-associated autoantibodies
- History of diabetic ketoacidosis or hyperosmolar hyperglycemic state
- Corticosteroid-induced or pancreatitis-induced diabetes
- History of chronic or acute pancreatitis
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- Known or suspected substance abuse
- Pregnancy
- Anticipated change in concomitant medication, which, in the opinion of the investigator, could interfere with the glucose metabolism (e.g. systemic corticosteroids or statins)
- Uncontrolled hypertension (systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 100 mmHg)
- Renal failure stage 5, defined as (estimated or exact) glomerular filtration rate < 15 mL/min/1.73m2
- Recent or planned major surgery (such as gastric bypass operation)
- Major psychiatric disorders, mental incapacity, unwillingness or language barrier precluding adequate understanding of the trial procedure or cooperation with the trial site personnel
- Life-threatening disease including malignant neoplasms and medical history of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer)
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites
Region Halland
Hålland
Region Skåne
Skåne
Västra Götalandsregionen
Västra Götaland
About this study
Official title: A 26-week, Multicenter, Controlled Trial of the Glycemic Outcomes of Individualized Treatment Support in Patients With Type 2 Diabetes
A 26-week, multicenter, parallel two-arm, randomized controlled trial of the glycemic outcomes of individualized treatment support in patients with type 2 diabetes. The primary objective of the trial is to confirm the superiority of standard of care with EASY DSS versus standard of care without EASY DSS in terms of glycemic control in patients with type 2 diabetes with ongoing treatment with any antidiabetic drug(s).
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Standard of Care with EASY DSS, Standard of Care without EASY DSS
- 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.
Standard of Care with EASY DSSDevice
The EASY DSS is a software tool designed to process and analyze data to facilitate individualized treatment suggestions for type 2 diabetes patients.
Patients will receive standard of care with a board certified physician with EASY DSS.
The choice of treatment will be made by the investigator. In the investigational arm this will be based on the clinical judgment of the investigator supplemented with support from the EASY DSS and in the control arm this will be based on the clinical judgment of the investigator alone.
Standard of Care without EASY DSSOther
Patients will receive standard of care with a board certified physician without EASY DSS.
The choice of treatment will be made by the investigator. In the investigational arm this will be based on the clinical judgment of the investigator supplemented with support from the EASY DSS and in the control arm this will be based on the clinical judgment of the investigator alone.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care with DSS | Experimental | Patients will receive standard of care with a board certified physician with EASY DSS.
The choice of treatment will be made by the investigator. In the investigational arm this will be based on the clinical judgment of the investigator supplemented with support from the EASY DSS and in the control arm this will be based on the clinical judgment of the investigator alone. Receives: Device: Standard of Care with EASY DSS |
| Standard of Care without DSS | Active comparator | Patients will receive standard of care with a board certified physician without EASY DSS.
The choice of treatment will be made by the investigator. In the investigational arm this will be based on the clinical judgment of the investigator supplemented with support from the EASY DSS and in the control arm this will be based on the clinical judgment of the investigator alone. Receives: Other: Standard of Care without EASY DSS |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Change from baseline HbA1c
Measured: 26 weeks
Secondary outcomes (3)
Fasting plasma glucose
Change from baseline in fasting plasma glucose (FPG)
Measured: 26 weeks
Achieving treatment target
Meeting treatment target of HbA1c < 7% (53 mmol/mol)
Measured: 26 weeks
Hypoglycemia
Meeting treatment target of HbA1c < 7% (53 mmol/mol) without severe or clinically significant hypoglycemic episodes
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2017
- Study start7 Aug 2017
- Primary completion12 Dec 2019
- Study completion19 Dec 2019
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 311 participants (actual)
Sponsor and investigators
- Lead sponsor
- Läkarexpressen AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Region Skane, Lund University, Region Halland, Västra Götalandsregionen
- Responsible party
- Sponsor
- Investigators
- Damon Tojjar, MD, Principal investigator, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03258268
- Sponsor's protocol ID
- EASY-1
- Acronym
- EASY-1
- Status last verified
- Sep 2020
- First submitted
- 20 Aug 2017
- Last updated
- 5 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 26-week, Multicenter, Controlled Trial of the Glycemic Outcomes of Individualized Treatment Support in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT03258268
- Acronym / sponsor ID
- EASY-1 / EASY-1
- Conditions
- Type 2 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 311 participants (actual)
- Lead sponsor
- Läkarexpressen ABIndustry (pharma, biotech, devices)
- Collaborators
- Region Skane, Lund University, Region Halland, Västra Götalandsregionen
- Study start
- 7 Aug 2017 (actual)
- Primary completion
- 12 Dec 2019 (actual)
- Study completion
- 19 Dec 2019 (actual)
- First posted
- 23 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.
A 26-week, multicenter, parallel two-arm, randomized controlled trial of the glycemic outcomes of individualized treatment support in patients with type 2 diabetes. The primary objective of the trial is to confirm the superiority of standard of care with EASY DSS versus standard of care without EASY DSS in terms of glycemic control in patients with type 2 diabetes with ongoing treatment with any antidiabetic drug(s).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Multicenter, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Standard of Care with DSS | Experimental | Device: Standard of Care with EASY DSSPatients will receive standard of care with a board certified physician with EASY DSS. The choice of treatment will be made by the investigator. In the investigational arm this will be based on the clinical judgment of the investigator supplemented with support from the EASY DSS and in the control arm this will be based on the clinical judgment of the investigator alone. |
| Standard of Care without DSS | Active comparator | Other: Standard of Care without EASY DSSPatients will receive standard of care with a board certified physician without EASY DSS. The choice of treatment will be made by the investigator. In the investigational arm this will be based on the clinical judgment of the investigator supplemented with support from the EASY DSS and in the control arm this will be based on the clinical judgment of the investigator alone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
- ≥ 18 years of age at the time of signing informed consent
- Type 2 diabetes (diagnosed clinically) ≥ 6 months prior to screening
- HbA1c ≥ 7.0 [58 mmol/mol] by central laboratory analysis
- Stable daily treatment with any single antidiabetic drug or any combination of antidiabetic drugs for at least 90 days prior to screening (dose adjustment ±10% of insulin dose and temporary dose correction because of e.g. infection are allowed)
Key exclusion criteria (14 listed)
- Previous participation in this trial. Participation is defined as informed consent.
- Currently participating in other clinical trials for diabetes
- Type 1 diabetes diagnosed clinically and/or by the presence of diabetes-associated autoantibodies
- History of diabetic ketoacidosis or hyperosmolar hyperglycemic state
- Corticosteroid-induced or pancreatitis-induced diabetes
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 |
|---|---|---|
| Standard of Care with EASY DSSThe EASY DSS is a software tool designed to process and analyze data to facilitate individualized treatment suggestions for type 2 diabetes patients. Patients will receive standard of care with a board certified physician with EASY DSS. The choice of treatment will be made by the investigator. In the investigational arm this will be based on the clinical judgment of the investigator supplemented with support from the EASY DSS and in the control arm this will be based on the clinical judgment of the investigator alone. | Device | Standard of Care with DSS |
| Standard of Care without EASY DSSPatients will receive standard of care with a board certified physician without EASY DSS. The choice of treatment will be made by the investigator. In the investigational arm this will be based on the clinical judgment of the investigator supplemented with support from the EASY DSS and in the control arm this will be based on the clinical judgment of the investigator alone. | Other | Standard of Care without DSS |
Primary outcome
HbA1c
Time frame: 26 weeks
Change from baseline HbA1c
3 secondary outcomes
Fasting plasma glucose
Time frame: 26 weeks
Achieving treatment target
Time frame: 26 weeks
Hypoglycemia
Time frame: 26 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2020.
- Individual participant dataSharing planned: No
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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.
Damon Tojjar, MD principal investigator
Lund University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Type 2 Diabetes Mellitus, run by Läkarexpressen AB at 3 sites in Sweden.
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 5 inclusion and 14 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: finished, as of the sponsor's last update on 5 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: 26 weeks). 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 5 Oct 2020.