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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03482154 -
Malglycemia in the Pediatric Hematopoietic Stem Cell Transplant Population
|
||
Completed |
NCT03667053 -
Trial to Confirm the Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in T1DM Children
|
Phase 3 | |
Active, not recruiting |
NCT03422471 -
Hypoglycemia and Autonomic Nervous System Function- B2
|
N/A | |
Recruiting |
NCT05379686 -
Low-Dose Glucagon and Advanced Hybrid Closed-Loop System for Prevention of Exercise-Induced Hypoglycaemia in People With Type 1 Diabetes
|
N/A | |
Completed |
NCT05597605 -
The SHINE Study: Safety of Implant and Preliminary Performance of the SHINE SYSTEM in Diabetic Subjects
|
N/A | |
Not yet recruiting |
NCT05990933 -
Role of Adrenaline in in the Inflammatory Response in Diabetes
|
N/A | |
Withdrawn |
NCT03736083 -
Introducing CGM at Type 1 Diabetes Diagnosis
|
N/A | |
Not yet recruiting |
NCT02909881 -
Dose Response Oxidation of a Sweet-corn Derived Sugar (PhytoSpherix) During Exercise in Endurance Trained Athletes
|
N/A | |
Completed |
NCT02966275 -
Post Bariatric Closed Loop Glucagon Trial
|
N/A | |
Withdrawn |
NCT02518022 -
How to be Safe With Alcoholic Drinks in Diabetes
|
N/A | |
Completed |
NCT02213003 -
Allogeneic Islet Cells Transplanted Onto the Omentum
|
Phase 1/Phase 2 | |
Completed |
NCT01147276 -
Vildagliptin and the Glucagon Response to Hypoglycemia in Type 1 Diabetes
|
Phase 4 | |
Completed |
NCT01176656 -
Hypoglycemia: Physician and Patient Perspectives
|
N/A | |
Completed |
NCT00998374 -
Comparison Between Pyloric Preserving and Non-Pyloric Preserving Bariatric Surgery With Glucose Challenge
|
N/A | |
Terminated |
NCT01225159 -
Tight Glycaemic Control During Cardiac Surgery
|
N/A | |
Completed |
NCT00373854 -
Study of How Low Blood Sugar Affects the Way Blood Vessels Work
|
N/A | |
Completed |
NCT00285233 -
Delayed Mycophenolate Mofetil in Single-Donor Islet Allotransplantation in Type 1 Diabetes
|
Phase 1/Phase 2 | |
Recruiting |
NCT05916131 -
Pilot Feasibility Study for HypoPals, a Mobile Health Program for Improving Hypoglycemia Management.
|
N/A | |
Terminated |
NCT04026750 -
Insulin Tolerance Test Study in Patients With Type 1 Diabetes
|
Phase 1 | |
Completed |
NCT05133765 -
The SMART B Exercise Study :''The SMART Study''
|
N/A |