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

NCT04190160 | Completed

• 1 other identifier: 141/18 XETD2
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Type2 Diabetes

Keywords

elderly, diabetes, safety, quality of life

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Glycemic control

  6 months

• Hypoglycaemia

  6 months

• Self reported depression (GDS)

  6 months

• Hypoglycaemic related hospitalizations

  6 months

• Cognitive function (MMSE)

  6 months

Study Arms (1)

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

Drug: IDegLira

Interventions

IDegLira DRUG

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

6 months treatment

Eligibility Criteria

• Age: 75 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• frail very old type 2 diabetes patients without severe cognitive impairment and/or grave depression with 3 or more daily hypoglycaemic drug administrations

You may not qualify if:

• 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

Sponsors & Collaborators

• Stefano Rizza: lead

Study Sites (1)

Stefano Rizza

Roma, 00133, Italy

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

IDegLira

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Massimo Federici, Professor

  Department of Systems Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 1, 2019
• First Posted: December 9, 2019
• Study Start: November 19, 2018
• Primary Completion: November 22, 2019
• Study Completion: March 25, 2021
• Last Updated: August 3, 2021

Record last verified: 2021-08

Locations

IT (1)