← Trials/Trial dossier/NCT02516657

CompletedPhase 3Results posted

Liraglutide in Adolescents With Type 1 Diabetes

Effect of Liraglutide on Glycemic Control, Glucagon Secretion and Inflammatory Markers in Adolescents With Type 1 Diabetes Mellitus

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

5

actual

Study population

Type 1 diabetes

Key I/E criterion

HbA1c ≤10%

Primary endpoint

Mean Weekly Blood Glucose

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 IDNCT02516657
Org study ID437619-6

Timeline

Milestones

Study first posted2015-08-06estimated
Primary completion2022-08-03actual
Study completion2023-08-03actual
Last update posted2025-04-20actual
Results first posted2025-04-20actual
Study start2012-05actual (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Type 1 diabetes

Eligibility

Who can enroll

Minimum age15 Years
Maximum age21 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

Diagnosis of Type 1 Diabetes Mellitus greater than 1 year
Insulin regimen - continuous subcutaneous insulin infusion with continuous glucose monitoring device
HbA1c <10%

Exclusion criteria

Previous exposure to liraglutide
History of abdominal surgery
Gastrointestinal reflux disease
History of acute or chronic pancreatitis
History of alcohol abuse or unwillingness to abstain from alcohol during the study
History of thyroid cancer
Family history of Multiple Endocrine Neoplasia 2B syndrome
Pregnant/breastfeeding females
Individuals with antibody-negative insulin requiring diabetes that is consistent with Monogenic Diabetes of Youth
Individuals with steroid induced or cystic fibrosis related diabetes

Endpoints (8)

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
4
Safety / tolerability / PK
4

Glycemic / diabetes

4 endpoints
Primary/registry result

Mean Weekly Blood Glucose

Time frame:Visit 1 (Before Liraglutide) at baseline (Day 0) vs. Visit 2 (After Liraglutide) on Day 7;

change from baseline, improvement

Posted result

GroupValue (mean), mg/dL95% CI
Liraglutide 0.6 mgVisit 1, before liraglutide187
Visit 2, after liraglutide178
Primary/protocol endpoint

Mean Weekly Blood Glucose

Time frame:Visit 1 (Before Liraglutide) at baseline (Day 0) vs. Visit 2 (After Liraglutide) on Day 7;

change from baseline, improvement

Secondary/registry result

Total Daily Insulin Dose

Time frame:Visit 1 (Before Liraglutide) at baseline (Day 0) vs. Visit 2 (After Liraglutide) on Day 7;

change from baseline, improvement

Posted result

GroupValue (mean), U/kg/day95% CI
Before Liraglutide0.97
Liraglutide Treatment0.67
Secondary/protocol endpoint

Total Daily Insulin Dose

Time frame:Visit 1 (Before Liraglutide) at baseline (Day 0) vs. Visit 2 (After Liraglutide) on Day 7;

change from baseline, improvement

Safety / tolerability / PK

4 endpoints
Other/protocol endpoint

Blood Sugar < 70 mg/dL

Time frame:Visit 1 (Before Liraglutide) at baseline (Day 0) vs. Visit 2 (After Liraglutide) on Day 7;

Documented hypoglycemia

event count, event

Other/protocol endpoint

Serum Amylase Level

Time frame:Visit 1 (Before Liraglutide) at baseline (Day 0) vs. Visit 2 (After Liraglutide) on Day 7;

change from baseline, descriptive

Other_pre_specified/registry result

Blood Sugar < 70 mg/dL

Time frame:Visit 1 (Before Liraglutide) at baseline (Day 0) vs. Visit 2 (After Liraglutide) on Day 7;

Documented hypoglycemia

event count, event

Posted result

GroupValue (mean), episodes95% CI
Before Liraglutide5.5
Liraglutide Treatment3.3
Other_pre_specified/registry result

Serum Amylase Level

Time frame:Visit 1 (Before Liraglutide) at baseline (Day 0) vs. Visit 2 (After Liraglutide) on Day 7;

change from baseline, descriptive

Posted result

GroupValue (mean), U/L95% CI
Before Liraglutide36
Liraglutide Treatment33

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableClinicalTrials.gov results section

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.