Clinical trial NCT04190160: Quality of Life and Fixed-ratio Combination of Insulin Degludec and Liraglutide (iDegLira)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type2 Diabetes
Keywords: elderly, diabetes, safety, quality of life
Lead sponsor: University of Rome Tor Vergata
Sponsor class: OTHER
First posted: 2019-12-09
Enrollment: 35
Sex: ALL
Minimum age (years): 75
Maximum age (years): 99
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Self reported quality of Life (CASP-19)
timeFrame: 6 months
measure: The Diabetes Treatment Satisfaction (DTSQ)
timeFrame: 6 months
Secondary outcomes:
measure: Glycemic control
timeFrame: 6 months
measure: Hypoglycaemia
timeFrame: 6 months
measure: Self reported depression (GDS)
timeFrame: 6 months
measure: Hypoglycaemic related hospitalizations
timeFrame: 6 months
measure: Cognitive function (MMSE)
timeFrame: 6 months
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Stefano Rizza
Study officials:
affiliation: Department of Systems Medicine
name: Massimo Federici, Professor
role: STUDY_CHAIR
References: