← Trials/Trial dossier/NCT02092896

T1DMLIRA

CompletedPhase 3

Liraglutide as add-on to Insulin in Type 1 Diabetes

Treatment With Liraglutide as add-on to Insulin in Type 1 Diabetic Patients. Effects on Glycemic Control and Counterregulation and Cognitive Performance During Hypoglycaemia

Lead sponsor

Hvidovre University Hospital

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Type 1 diabetes

Key I/E criteria

•BMI 18-28•HbA1c ≥8%

Primary endpoints

•HbA1c, change•Changes from baseline in EEG and cognitive performances•Gastric emptying rate

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT02092896

Org study ID2012-002526-67

Timeline

Milestones

Study first posted2014-03-20estimated

Last update posted2015-04-01estimated

Study start2013-03 (month precision)

Primary completion2014-10actual (month precision)

Study completion2014-10actual (month precision)

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Type 1 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age70 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Age: 18-70 years

•BMI: 18-28

•HbA1c ≥ 8 %

•No residual β-cell function (glucagon test with c-peptide < 60 pM)

•Caucasian

•Diagnosed with type 1 diabetes at 5 to 40 years of age (both inclusive).

•Remission phase must be completed

•Female participants must use adequate contraception

•Informed consent

Exclusion criteria

•Overt diabetes complications; creatinin > 130 µM, proliferative retinopathy, macroalbuminuria.

•Autonomic neuropathy (RR-variation </=10 beats/min) and/or Orthostatic hypotension (OH).

•Anemia, Hb concentration; female <7.0 mmol/l, male<8.0 mmol/l

•Pregnancy or lactation

•Epilepsy

•Use of antiepileptic medication

•Use of beta blockers

•Previously apoplexy cerebri.

•Any use of benzodiazepine within the last month

•Any use of neuroleptic drugs within the last six months

•Self-perceived hearing loss

•Alcohol or drug abuse

•Allergy to the medication or placebo.

•Treatment with any medication affecting glucose metabolism.

•Any disorder which in the investigators opinion could interfere with the safety and results of the trial

Endpoints (11)

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

Glycemic / diabetes

Safety / tolerability / PK

Other clinical outcomes

Other (unclassified)

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Change from baseline in body weight

Time frame:week 0, week 12

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

3 endpoints

Primary/protocol endpoint

Change from baseline in HbA1c (glycosylated haemoglobin)

Time frame:Week 0, week 12

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint/low confidence

Change from baseline in glycemic control (CGM)

Time frame:week 0, week 12

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in total daily insulin dose

Time frame:week 0, week 12

change from baseline, improvement

Safety / tolerability / PK

3 endpoints

Secondary/protocol endpoint

Change from baseline in corrected QTc-interval (QTc) during hypoglycemia

Time frame:week 0, week 12

change from baseline, descriptive

Secondary/protocol endpoint

Change from baseline in hypoglycemic symptom score

Time frame:week 0, week 12

change from baseline, improvement

Other/protocol endpoint

Frequency of Hypoglycemic episodes

Time frame:Week 0, week 12

Documented hypoglycemia

event count, event

Other clinical outcomes

2 endpoints

Primary/protocol endpoint/low confidence

Changes from baseline in EEG and cognitive performances

Time frame:week 0, week 12

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from baseline in auditory evoked potentials (AEP) during hypoglycemia

Time frame:week 0, week 12

change from baseline, descriptive

Other (unclassified)

2 endpoints

Primary/protocol endpoint/low confidence

Change from baseline in gastric emptying rate

Time frame:week 0, week 12

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Changes from baseline in the counterregulatory hormone responses during hypoglycemia

Time frame:week 0, week 12

change from baseline, descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Twelve-Week Treatment With Liraglutide as Add-on to Insulin in Normal-Weight Patients With Poorly Controlled Type 1 Diabetes: A Randomized, Placebo-Controlled, Double-Blind Parallel Study.
Diabetes care2015 Dec (month)PMID26486191doi:10.2337/dc15-1037via clinicaltrials gov reference derived + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 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 1, 2026 snapshot.