Hypoglycemia Clinical Trial
Official title:
Simplification of Complex Insulin Regimens With Preserving Good Glycemic Control in Type 2 Diabetes
NCT number | NCT04020445 |
Other study ID # | BekesCCH |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 1, 2016 |
Est. completion date | January 1, 2022 |
Verified date | February 2023 |
Source | Bekes County Central Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study examines prospectively the safety and efficacy of switching from multiple daily insulin injections (MDI) to once daily IDegLira (insulin degludec and liraglutide fix ratio combination), a fixed-ratio combination of insulin degludec and liraglutide, in relatively well controlled (HbA1c<7.5%) subjects with type 2 diabetes using low total daily insulin dose (TDD).
Status | Completed |
Enrollment | 150 |
Est. completion date | January 1, 2022 |
Est. primary completion date | January 1, 2022 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Type 2 diabetic (T2D) patients >18 years old - detectable random, non-fasting serum C-peptide levels - HbA1c=< 7.5% - treated with MDI (with stable daily doses of insulin at least for 90 days prior to baseline visit) - using relatively low total daily insulin dose (TDD), at baseline visit low TDD is defined as TDD<70 IU/day and TDD<0.6 IU/kg/day at the same time. Exclusion Criteria: - Type 1 diabetes - treatment of T2D with any medication for diabetes other than insulin or metformin during 90 days before baseline visit - active cancer - anaemia (haemoglobin <100g/l) - acute or chronic kidney disease with an estimated glomerular filtration rate <30 mL/min/1.73 m2 |
Country | Name | City | State |
---|---|---|---|
Hungary | Zoltán Taybani | Békéscsaba | Békés |
Lead Sponsor | Collaborator |
---|---|
Bekes County Central Hospital | Szeged University, University of Debrecen |
Hungary,
Taybani Z, Botyik B, Katko M, Gyimesi A, Varkonyi T. Simplifying Complex Insulin Regimens While Preserving Good Glycemic Control in Type 2 Diabetes. Diabetes Ther. 2019 Oct;10(5):1869-1878. doi: 10.1007/s13300-019-0673-8. Epub 2019 Jul 25. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants reaching HbA1c<7% and HbA1c<6.5% | HbA1c is measuerd by laboratory blood test | it is checked at baseline and at 3, 6, 9 and 12 months | |
Primary | change in body weight from baseline to 3, 6, 9 and 12 months | body weight is measured at the diabetes ambulance | it is checked at baseline and at 3, 6, 9 and 12 months | |
Primary | change in risk of hypoglycemia from baseline to 3, 6, 9 and 12 months | hypoglycemia risk is assessed by analysing the patients' diary | it is checked at baseline and at 3, 6, 9 and 12 months |
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