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WithdrawnPhase 3

Anti-diabetic Effects of Liraglutide in Adolescents and Young Subjects With Type 1 Diabetes

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

actual

Study population

Type 1 diabetes

Key I/E criteria

BMI ≤95HbA1c ≤9%

Primary endpoint

Mean weekly blood glucose concentrations

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 IDNCT01722227
Org study ID1964 Liraglutide ADA
Secondary ID1-12-CT-20American Diabetes Association

Timeline

Milestones

Study first posted2012-11-06estimated
Last update posted2017-02-09estimated
Study start2012-11 (month precision)
Primary completion2017-11estimated (month precision)
Study completion2018-05estimated (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Type 1 diabetes

Eligibility

Who can enroll

Minimum age15 Years
Maximum age30 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

INCLUSION CRITERIA:

1. Females and males with Type 1 diabetes as ascertained by islet autoantibodies (GAD-65 and/or islet cell antibodies)

2. Age 15-30 years - This age group is being chosen as most will have completed puberty with the accompanying physiologic phase of increased insulin resistance. In addition, this age group shows increased self-management capabilities. Extending the age up to 30 years will allow us to include young adults, since type 1 diabetes is frequently diagnosed in the late teen and early adult years. This study is not powered to detect differences in liraglutide efficacy in different age group but it may provide insight into the effectiveness in the teenage population, in whom optimal glycemic control is often a challenge.

3. Type 1 diabetes duration greater than 1 year to ensure that a majority of subjects are beyond the partial remission period.

4. Fasting C-peptide level ≤ 0.3 ng/ml.

5. HbA1c level equal or less than 9%

6. Insulin delivery by CSII - the choice is made to facilitate adherence to study drug and also to enable us have a homogeneous group to analyze without having to analyze the data for the covariants of CSII vs. multiple daily injection therapy.

7. Subjects willing to wear a CGM sensor and perform home blood glucose monitoring four times daily and with symptoms of hypoglycemia.

8. Subjects well-versed in carbohydrate counting.

9. BMI < 95th% for age and gender.

Exclusion criteria

EXCLUSION CRITERIA:

1. Previous exposure to liraglutide

2. History of abdominal surgery

3. History of gastroparesis or gastrointestinal reflux disease;

4. History of acute or chronic pancreatitis

5. Cirrhosis or hepatic disease defined as transaminases levels > 3 times normal

6. Impaired renal function defined as serum creatinine >1.5.

7. HIV or Hepatitis C positive status

8. Pregnant/breastfeeding females

9. Individuals with steroid-induced or cystic fibrosis related diabetes

10. Diabetic Ketoacidosis within 6 months of the study

11. History of severe hypoglycemia (seizure, loss of consciousness) within 6 months of the study

12. History of medullary thyroid cancer or MEN2 syndrome

13. Any other life-threatening cardiac or non-cardiac disease

14. Participation in a concurrent clinical trial or participation in a trial within 30 days preceding the study period.

15. Unable to give informed consent/assent.

16. Adolescents and adults who are considered underweight based on body mass index (BMI):

1. For adolescents: BMI less than the 5th percentile

2. For adults: BMI below 18.5

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.

Glycemic / diabetes

2 endpoints
Primary/protocol endpoint

Mean weekly blood glucose concentrations.

Time frame:3 Months

change from baseline, improvement

Secondary/protocol endpoint

HbA1c

Time frame:3 Months

HbA1c, change

change from baseline, improvement

LOINC 4548-4

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.