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

Type2 Diabetes Clinical Trial

— XETD2  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04190160
• Other study ID #: 141/18 XETD2
• Status: Completed
• Phase: N/A
• Start date: November 19, 2018
• Est. completion date: March 25, 2021

Study information

• Verified date: August 2021
• Source: University of Rome Tor Vergata
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 dose of a fixed combination of insulin degludec and liraglutide. This therapeutic semplification will be done indipendently of pre-existent glicaemic control.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: March 25, 2021
• Est. primary completion date: November 22, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 75 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type2 Diabetes

Intervention

Drug:
• IDegLira
A single administration of IDegLira, dose depending on glicaemic control, in place of any pre-existing hipoglycaemic therapeutic scheme

Locations

Country	Name	City	State
Italy	Stefano Rizza	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Stefano Rizza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self reported quality of Life (CASP-19)	All participants with treatment-related modification of quality of life as assessed by CASP-19	6 months
Primary	The Diabetes Treatment Satisfaction (DTSQ)	All participants with treatment-related self reported satisfation for diabetes therapy as assessed by DTSQ	6 months
Secondary	Glycemic control	Glycaemic control evaluated by treatment-related modification of fasting glucose and HbA1c	6 months
Secondary	Hypoglycaemia	Self reported hypoglycaemic events rate	6 months
Secondary	Self reported depression (GDS)	All participants with treatment-related modification of depression as assessed by GDS (Geriatric Depression Scale)	6 months
Secondary	Hypoglycaemic related hospitalizations	Numbers of treatment-related hypoglycaemic hospitalizations	6 months
Secondary	Cognitive function (MMSE)	All participants with treatment-related modification of cognitive function as assessed by Mini Mental State Examination (MMSE)	6 months