XETD2

CompletedPhase NA

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

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)

Lead sponsor

Stefano Rizza

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

Study population

Type 2 diabetes

Eligibility highlights

•Age 75-99

Primary endpoints

•Self reported quality of Life (CASP-19)•Diabetes Treatment Satisfaction (DTSQ)

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04190160

Org study ID141/18 XETD2

Timeline

Milestones

Study start2018-11-19actual

Primary completion2019-11-22actual

Study first posted2019-12-09actual

Study completion2021-03-25actual

Last update posted2021-08-03actual

Assets

Investigational agents

Liraglutide

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age75 Years

Maximum age99 Years

SexAll

Healthy volunteersAccepted

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

Endpoints (7)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Patient-reported / QoL

Safety / tolerability / PK

Glycemic / diabetes

Other clinical outcomes

Glycemic / diabetes

1 endpoint

Secondary/protocol endpoint

Glycemic control

Time frame:6 months

change from baseline, improvement

componentsFasting glucose, change, HbA1c, change

Patient-reported / QoL

3 endpoints

Primary/protocol endpoint

Self reported quality of Life (CASP-19)

Time frame:6 months

change from baseline, improvement

Primary/protocol endpoint

The Diabetes Treatment Satisfaction (DTSQ)

Time frame:6 months

descriptive, improvement

Secondary/protocol endpoint

Self reported depression (GDS)

Time frame:6 months

descriptive, improvement

Safety / tolerability / PK

2 endpoints

Secondary/protocol endpoint

Hypoglycaemia

Time frame:6 months

event count, event

Secondary/protocol endpoint

Hypoglycaemic related hospitalizations

Time frame:6 months

event count, event

Other clinical outcomes

1 endpoint

Secondary/protocol endpoint

Cognitive function (MMSE)

Time frame:6 months

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.