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ELEGANT

UnknownPhase NA

Liraglutide and Insulin Therapy in Patients With Type 2 Diabetes

The Effect of Liraglutide on Insulin-associated wEight GAiN in Patients With Type 2 Diabetes Mellitus (ELEGANT Trial)

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

-

Actual enrollment

50

Study population

Obesity / overweight, Type 2 diabetes

Eligibility highlights

•BMI ≥25•HbA1c 6.5-8.5%

Primary endpoint

•Body weight, absolute change (kg)

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 IDNCT01392898
Org study IDLir-HJCJ-03

Timeline

Milestones

Study first posted2011-07-13estimated
Last update posted2013-08-02estimated
Study start2012-02 (month precision)
Primary completion2014-05estimated (month precision)
Study completion2014-05estimated (month precision)

Assets

Investigational agents

Liraglutide

Who this study enrolls

Obesity / overweightType 2 diabetes

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Patients with type 2 diabetes mellitus on short-term insulin therapy (≤ 12 months); all types of insulin allowed
•Documented insulin-associated weight gain ≥ 3.0 kg from the start of insulin therapy until inclusion
•Age 18-75 years
•BMI ≥ 25 kg/m2
•Stable glycaemic control mirrored by HbA1c ≥ 6.5 and ≤ 8.5 %

Exclusion criteria

•Inability to provide informed consent
•Type 1 diabetes mellitus, MODY diabetes, or LADA diabetes (presence of anti-GAD)
•Presence of any medical condition that might interfere with the current study protocol.
•Inflammatory bowel disease (e.g. M. Crohn, ulcerative colitis)
•Recurrent hypoglycaemic events
•Diabetic gastroparesis
•Heart failure (LVEF ≤ 30%)
•Use of TZDs (glitazones), DDP-IV (dipeptidylpeptidase-inhibitor)
•Use of medication associated with impaired glucose metabolism including corticosteroids
•Pregnancy or breast-feeding (contraception of at least 3 months before inclusion is required for fertile women)
•Pre-existing thyroid disease
•Liver disease (aspartate aminotransferase or alanine aminotransferase level of more than three times the upper limit of normal range)
•Renal disease (creatinine > 130 µmol/l or MDRD-GFR <30 ml/min/1.73m2)

Endpoints (2)

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

Weight & body composition
1
Glycemic / diabetes
1

Weight & body composition

1 endpoint
Primary/protocol endpoint

Body weight change (measured body weight at 26 weeks minus baseline body weight)

Time frame:26 weeks (26 weeks - baseline)

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint

Measuring change in insulin dose (insulin dose at 26 weeks minus insulin dose at baseline)

Time frame:26 weeks (26 weeks -baseline)

change from baseline, improvement

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

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.