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Completed

NCT Number: NCT04190160

Quality of Life and 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.

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Key information

Age range

75 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stefano Rizza

Roma, 00133, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IDegLira

Drug

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

Primary outcomes

  1. Self reported quality of Life (CASP-19)

    Time frame: 6 months

    All participants with treatment-related modification of quality of life as assessed by CASP-19

  2. The Diabetes Treatment Satisfaction (DTSQ)

    Time frame: 6 months

    All participants with treatment-related self reported satisfation for diabetes therapy as assessed by DTSQ

Secondary outcomes

  1. Glycemic control

    Time frame: 6 months

    Glycaemic control evaluated by treatment-related modification of fasting glucose and HbA1c

  2. Hypoglycaemia

    Time frame: 6 months

    Self reported hypoglycaemic events rate

  3. Self reported depression (GDS)

    Time frame: 6 months

    All participants with treatment-related modification of depression as assessed by GDS (Geriatric Depression Scale)

  4. Hypoglycaemic related hospitalizations

    Time frame: 6 months

    Numbers of treatment-related hypoglycaemic hospitalizations

  5. Cognitive function (MMSE)

    Time frame: 6 months

    All participants with treatment-related modification of cognitive function as assessed by Mini Mental State Examination (MMSE)

Sponsors and collaborators

Lead sponsor

Stefano Rizza

Other

Registry information

Official study 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)

Acronym: XETD2

Important dates

Study start
2018
Primary completion
2019
Study completion
2021
First posted
Dec 9, 2019
Registry last updated
Aug 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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