- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04020445
Simplification of Complex Insulin Regimens With Preserving Good Glycemic Control in Type 2 Diabetes
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Type 2 diabetic patients suffering from severe hyperglycemia are often apply multiple daily insulin injections (MDI). If glucose toxicity resolves, the regimen may potentially be simplified, but there are no specific guidelines regarding this and a lot of patients are left on MDI.
The Investigators aimed to examine prospectively the safety and efficacy of switching from MDI to once daily IDegLira, 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).
The investigators hypothesize that in everyday clinical practice switching from low dose MDI to IDegLira in patients of different ages with well-controlled (or overcontrolled) type 2 diabetes is safe, may induce weight loss and result in similar or better glycemic control.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Zoltán J Taybani, MD
- Phone Number: +3666555562
- Email: taybaniz@bmkk.eu
Study Locations
-
-
Békés
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Békéscsaba, Békés, Hungary, 5600
- Zoltán Taybani
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants reaching HbA1c<7% and HbA1c<6.5%
Time Frame: it is checked at baseline and at 3, 6, 9 and 12 months
|
HbA1c is measuerd by laboratory blood test
|
it is checked at baseline and at 3, 6, 9 and 12 months
|
change in body weight from baseline to 3, 6, 9 and 12 months
Time Frame: it is checked at baseline and at 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
|
change in risk of hypoglycemia from baseline to 3, 6, 9 and 12 months
Time Frame: it is checked at baseline and at 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
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BekesCCH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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