HBA1cNCT04020445
Simplification of Complex Insulin Regimens With Preserving Good Glycemic Control in Type 2 Diabetes
An observational study of HBA1c and Body Weight, run by Bekes County Central Hospital at 1 site in Hungary.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HBA1c, Body Weight, Hypoglycemia
- What is being tested?
- de-escalation of complex insulin regimens
- How many people
- 150 participants
- Where
- 1 siteHungary
- Study dates
- 1 Jan 2016to 1 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Well-controlled or overtreated adult type 2 diabetic patients using relatively low dose MDI.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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.
- Conditions
- HBA1c, Body Weight, Hypoglycemia
- Being tested
- de-escalation of complex insulin regimens
- Keywords
- iDegLira, deintensification, overtreatment, simplification, type 2 diabetes
- Medical subject headings
- Body Weight, Hypoglycemia, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
de-escalation of complex insulin regimensOther
complex insulin regimens are switched to fix ratio combinations consisting of of a basal insulin and a GLP-1 (glucagon-like peptide-1) receptor agonist
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants reaching HbA1c<7% and HbA1c<6.5%
HbA1c is measuerd by laboratory blood test
Measured: 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
body weight is measured at the diabetes ambulance
Measured: 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
hypoglycemia risk is assessed by analysing the patients' diary
Measured: it is checked at baseline and at 3, 6, 9 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study start1 Jan 2016
- Primary completion1 Jan 2022
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HBA1cStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bekes County Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Debrecen, Szeged University
- Responsible party
- Principal investigator, Zoltán Taybani, Bekes County Central Hospital
- Investigators
- Zoltán J Taybani, MD, Principal investigator, Bekes County Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04020445
- Sponsor's protocol ID
- BekesCCH
- Status last verified
- Feb 2023
- First submitted
- 10 Jul 2019
- Last updated
- 13 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 31347100
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simplification of Complex Insulin Regimens With Preserving Good Glycemic Control in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT04020445
- Acronym / sponsor ID
- BekesCCH
- Conditions
- HBA1c, Body Weight, Hypoglycemia
- Keywords
- iDegLira, deintensification, overtreatment, simplification, type 2 diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Bekes County Central HospitalUniversity, hospital or other
- Collaborators
- University of Debrecen, Szeged University
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 16 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Well-controlled or overtreated adult type 2 diabetic patients using relatively low dose MDI.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| de-escalation of complex insulin regimenscomplex insulin regimens are switched to fix ratio combinations consisting of of a basal insulin and a GLP-1 (glucagon-like peptide-1) receptor agonist | Other | – |
Primary outcome
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
- Results publication: PubMed 31347100Taybani 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zoltán J Taybani, MD principal investigator
Bekes County Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HBA1c and Body Weight, run by Bekes County Central Hospital at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04020445, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2023.