Quality of Life and Fixed-ratio Combination of Insulin Degludec and Liraglutide (iDegLira) (XETD2)

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.

Study Overview

• Status: Completed
• Conditions: Type2 Diabetes
• Intervention / Treatment: Drug: IDegLira

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 Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Roma, Italy, 00133
    • Stefano Rizza

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 73 years to 97 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Stefano Rizza
• Investigators: Study Chair: Massimo Federici, Professor, Department of Systems Medicine

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2018
• Primary Completion (Actual): November 22, 2019
• Study Completion (Actual): March 25, 2021

Study Registration Dates

• First Submitted: December 1, 2019
• First Submitted That Met QC Criteria: December 4, 2019
• First Posted (Actual): December 9, 2019

Study Record Updates

• Last Update Posted (Actual): August 3, 2021
• Last Update Submitted That Met QC Criteria: August 2, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: elderly, diabetes, safety, quality of life
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Incretins; Xultophy
• Other Study ID Numbers: 141/18 XETD2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No