Quality of Life and Fixed-ratio Combination of Insulin Degludec and Liraglutide (iDegLira)

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Type2 Diabetes

Intervention / Treatment
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* Drug: IDegLira


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: frail very old type 2 diabetes patients without severe cognitive impairment and/or grave depression with 3 or more daily hypoglycaemic drug administrations Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 75 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 6 months treatment<br>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 | Drug: IDegLira<br>* A single administration of IDegLira, dose depending on glicaemic control, in place of any pre-existing hipoglycaemic therapeutic scheme<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self reported quality of Life (CASP-19) | All participants with treatment-related modification of quality of life as assessed by CASP-19 | 6 months | 
| The Diabetes Treatment Satisfaction (DTSQ) | All participants with treatment-related self reported satisfation for diabetes therapy as assessed by DTSQ | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic control | Glycaemic control evaluated by treatment-related modification of fasting glucose and HbA1c | 6 months | 
| Hypoglycaemia | Self reported hypoglycaemic events rate | 6 months | 
| Self reported depression (GDS) | All participants with treatment-related modification of depression as assessed by GDS (Geriatric Depression Scale) | 6 months | 
| Hypoglycaemic related hospitalizations | Numbers of treatment-related hypoglycaemic hospitalizations | 6 months | 
| Cognitive function (MMSE) | All participants with treatment-related modification of cognitive function as assessed by Mini Mental State Examination (MMSE) | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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elderly, diabetes, safety, quality of life