Status:
COMPLETED
Easy Diabetes Treatment Study 1
Lead Sponsor:
Läkarexpressen AB
Collaborating Sponsors:
Region Skane
Lund University
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
August 7 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 19 2019
Estimated Enrollment :
311 Patients enrolled
Trial Details
Trial ID
NCT03258268
Start Date
August 7 2017
End Date
December 19 2019
Last Update
October 5 2020
Active Locations (3)
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1
Region Halland
Hålland, Sweden
2
Region Skåne
Skåne, Sweden
3
Västra Götalandsregionen
Västra Götaland, Sweden