Type2 DiabetesXETD2NCT04190160
Quality of Life and Fixed-ratio Combination of Insulin Degludec and Liraglutide (iDegLira)
A study testing IDegLira in people with Type2 Diabetes, run by Stefano Rizza at 1 site in Italy.
Trial summary
This work is aimed at improving the quality of life of older patients affected by type 2 diabetes. The investigators will try to amiliorate the complexity of hypogliceamic treatment in a little group of older patients with type 2 diabetes reducing the number of pills and/or insulin administration using a single daily… Read more about this study
- Who is it for?
- Ages 75 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Type2 Diabetes
- What is being tested?
- IDegLira
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteItaly
- Study dates
- 19 Nov 2018to 25 Mar 2021
- Phase
- Interventional
- 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 75 to 99 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- frail very old type 2 diabetes patients without severe cognitive impairment and/or grave depression with 3 or more daily hypoglycaemic drug administrations
Who cannot join
- e-GFR < 15 ml/min
- any experimental clinical trial participation or every experimental drug use in the previous 6 months before commencing this study
- every know or suspected allergic reaction to deglutec or any other GLP-1 agonist
- any known contraindication to IDegLira use (as described in product characteristics)
- Recent cancer diagnosis (<3 y) or active radio- or chemo-therapy. Cancer diagnosis older than 3 years before commencing the study is allowed
- Mini mental state examination score lower than 14/30 and/or Activity Daily Living score lower than 1/6 and/or Instrumenctal Activity Daily Living lower than 1/8
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Unicenter Interventional Study Aimed at Improving the Quality of Life in a Group of Very Old Patients With Type 2 Diabetes With Fixed-ratio Combination of Insulin Degludec and Liraglutide (iDegLira)
This work is aimed at improving the quality of life of older patients affected by type 2 diabetes. The investigators will try to amiliorate the complexity of hypogliceamic treatment in a little group of older patients with type 2 diabetes reducing the number of pills and/or insulin administration using a single daily dose of a fixed combination of insulin degludec and liraglutide. This therapeutic semplification will be done indipendently of pre-existent glicaemic control.
Read the detailed description
Older patients with type 2 diabetes often have numerous coexisting medical problems for which these subjets prescribed multiple medications. Actually, diabetes, hyertension, cardiovascular diseases (CVDs), neurodegenerative diseases (NDDs), digestive and respiratory disorders are common in aged peolple and tend to coexist. Unfortunally, the complex therapy of these diseases increases the risk of adverse drug events. Furthermore, there is marked heterogeneity in health status and functional capacity in older diabetic subjects, often making prescribing decisions complex and challenging. On the other hand, despite of the use of many medicines, undertreatment is also frequent present in the elderly and the probability of underprescription increased significantly with the number of medicines.Both conditions have a detrimental effect on quality of life (QoL) of elderly subjects increasing the risk of disability and death. Therefore, older people should benefit greatly of a simplification of drug regimens and reduction of pill burdens as well as better explanations of the reason for the prescriptions. The combination of insulin degludec (100 units/mL) and liraglutide (3.6 mg/mL), termed IDegLira, was approved in 2014 for the treatment of type 2 diabetes inadequately controlled with oral glucose-lowering agents alone or in combination with a GLP-1 receptor agonist or basal insulin (European indication). Interestingly, RCTs and real-world evidence provided insights into effectiveness and safety in routine clinical practice. However, beyond its known metabolic efficacy IDegLira has a very small hypoglicaemic rate, with a single daily and flexible administration dose and a very good safety profile that makes it suitable for fragile diabetic old patients.
- Conditions
- Type2 Diabetes
- Being tested
- IDegLira
- Keywords
- elderly, diabetes, safety, quality of life
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IDegLiraDrug
A single administration of IDegLira, dose depending on glicaemic control, in place of any pre-existing hipoglycaemic therapeutic scheme
| Study group | Role | What they receive |
|---|---|---|
| 6 months treatment | Experimental | replacement of whatever pre-existing hypoglicaemic therapeutic scheme, with or without insulin, with a single daily and flexible administration of IDegLira in a pilot little group of very old diabetic patients Receives: Drug: IDegLira |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self reported quality of Life (CASP-19)
All participants with treatment-related modification of quality of life as assessed by CASP-19
Measured: 6 months
The Diabetes Treatment Satisfaction (DTSQ)
All participants with treatment-related self reported satisfation for diabetes therapy as assessed by DTSQ
Measured: 6 months
Secondary outcomes (5)
Glycemic control
Glycaemic control evaluated by treatment-related modification of fasting glucose and HbA1c
Measured: 6 months
Hypoglycaemia
Self reported hypoglycaemic events rate
Measured: 6 months
Self reported depression (GDS)
All participants with treatment-related modification of depression as assessed by GDS (Geriatric Depression Scale)
Measured: 6 months
Hypoglycaemic related hospitalizations
Numbers of treatment-related hypoglycaemic hospitalizations
Measured: 6 months
Cognitive function (MMSE)
All participants with treatment-related modification of cognitive function as assessed by Mini Mental State Examination (MMSE)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2019
- Study start19 Nov 2018
- Primary completion22 Nov 2019
- Study completion25 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2 DiabetesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stefano Rizza
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Stefano Rizza, University of Rome Tor Vergata
- Investigators
- Massimo Federici, Professor, Study chair, Department of Systems Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04190160
- Sponsor's protocol ID
- 141/18 XETD2
- Acronym
- XETD2
- Status last verified
- Aug 2021
- First submitted
- 1 Dec 2019
- Last updated
- 3 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unicenter Interventional Study Aimed at Improving the Quality of Life in a Group of Very Old Patients With Type 2 Diabetes With Fixed-ratio Combination of Insulin Degludec and Liraglutide (iDegLira)
- ClinicalTrials.gov ID
- NCT04190160
- Acronym / sponsor ID
- XETD2 / 141/18 XETD2
- Conditions
- Type2 Diabetes
- Keywords
- elderly, diabetes, safety, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Stefano RizzaUniversity, hospital or other
- Study start
- 19 Nov 2018 (actual)
- Primary completion
- 22 Nov 2019 (actual)
- Study completion
- 25 Mar 2021 (actual)
- First posted
- 9 Dec 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 work is aimed at improving the quality of life of older patients affected by type 2 diabetes. The investigators will try to amiliorate the complexity of hypogliceamic treatment in a little group of older patients with type 2 diabetes reducing the number of pills and/or insulin administration using a single daily dose of a fixed combination of insulin degludec and liraglutide. This therapeutic semplification will be done indipendently of pre-existent glicaemic control.
Detailed description
Older patients with type 2 diabetes often have numerous coexisting medical problems for which these subjets prescribed multiple medications. Actually, diabetes, hyertension, cardiovascular diseases (CVDs), neurodegenerative diseases (NDDs), digestive and respiratory disorders are common in aged peolple and tend to coexist. Unfortunally, the complex therapy of these diseases increases the risk of adverse drug events. Furthermore, there is marked heterogeneity in health status and functional capacity in older diabetic subjects, often making prescribing decisions complex and challenging. On the other hand, despite of the use of many medicines, undertreatment is also frequent present in the elderly and the probability of underprescription increased significantly with the number of medicines.Both conditions have a detrimental effect on quality of life (QoL) of elderly subjects increasing the risk of disability and death. Therefore, older people should benefit greatly of a simplification of drug regimens and reduction of pill burdens as well as better explanations of the reason for the prescriptions. The combination of insulin degludec (100 units/mL) and liraglutide (3.6 mg/mL), termed IDegLira, was approved in 2014 for the treatment of type 2 diabetes inadequately controlled with oral glucose-lowering agents alone or in combination with a GLP-1 receptor agonist or basal insulin (European indication). Interestingly, RCTs and real-world evidence provided insights into effectiveness and safety in routine clinical practice. However, beyond its known metabolic efficacy IDegLira has a very small hypoglicaemic rate, with a single daily and flexible administration dose and a very good safety profile that makes it suitable for fragile diabetic old patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 6 months treatment | Experimental | Drug: IDegLirareplacement of whatever pre-existing hypoglicaemic therapeutic scheme, with or without insulin, with a single daily and flexible administration of IDegLira in a pilot little group of very old diabetic patients |
Who may qualify
- Ages
- 75 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- frail very old type 2 diabetes patients without severe cognitive impairment and/or grave depression with 3 or more daily hypoglycaemic drug administrations
Key exclusion criteria (6 listed)
- e-GFR < 15 ml/min
- any experimental clinical trial participation or every experimental drug use in the previous 6 months before commencing this study
- every know or suspected allergic reaction to deglutec or any other GLP-1 agonist
- any known contraindication to IDegLira use (as described in product characteristics)
- Recent cancer diagnosis (<3 y) or active radio- or chemo-therapy. Cancer diagnosis older than 3 years before commencing the study is allowed
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 |
|---|---|---|
| IDegLiraA single administration of IDegLira, dose depending on glicaemic control, in place of any pre-existing hipoglycaemic therapeutic scheme | Drug | 6 months treatment |
Primary outcome
Self reported quality of Life (CASP-19)
Time frame: 6 months
All participants with treatment-related modification of quality of life as assessed by CASP-19
The Diabetes Treatment Satisfaction (DTSQ)
Time frame: 6 months
All participants with treatment-related self reported satisfation for diabetes therapy as assessed by DTSQ
5 secondary outcomes
Glycemic control
Time frame: 6 months
Hypoglycaemia
Time frame: 6 months
Self reported depression (GDS)
Time frame: 6 months
Hypoglycaemic related hospitalizations
Time frame: 6 months
Cognitive function (MMSE)
Time frame: 6 months
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 3 Aug 2021.
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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.
Massimo Federici, Professor study chair
Department of Systems Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IDegLira in people with Type2 Diabetes, run by Stefano Rizza at 1 site in Italy.
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 1 inclusion and 6 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 3 Aug 2021. 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 Italy. 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?
Self reported quality of Life (CASP-19) (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Aug 2021.