Clinical trial NCT03258268: Easy Diabetes Treatment Study 1
Official title: A 26-week, Multicenter, Controlled Trial of the Glycemic Outcomes of Individualized Treatment Support in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Läkarexpressen AB
Sponsor class: INDUSTRY
Collaborators: name: Region Skane
name: Lund University
name: Region Halland
name: Västra Götalandsregionen
First posted: 2017-08-23
Enrollment: 311
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter, randomized controlled trial
Primary purpose: TREATMENT

Brief 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 glycemic control in patients with type 2 diabetes with ongoing treatment with any antidiabetic drug(s).


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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
* 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)

Primary outcomes:
measure: HbA1c
timeFrame: 26 weeks
Secondary outcomes:
measure: Fasting plasma glucose
timeFrame: 26 weeks
measure: Achieving treatment target
timeFrame: 26 weeks
measure: Hypoglycemia
timeFrame: 26 weeks
Other outcomes:
Locations:
city: Halland
country: Sweden
facility: Region Halland
city: Skåne
country: Sweden
facility: Region Skåne
city: Västra Götaland
country: Sweden
facility: Västra Götalandsregionen
Study officials:
affiliation: Lund University
name: Damon Tojjar, MD
role: PRINCIPAL_INVESTIGATOR
References: