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Anti-diabetic Effects of Liraglutide in Adolescents and Young Subjects With Type 1 Diabetes
Lead sponsor
Asset
Liraglutide
Subcutaneous · GLP-1 agonist
Listed sites
1
Recruiting sites
—
Enrollment
—
actual
Study population
Type 1 diabetes
Key I/E criteria
•BMI ≤95•HbA1c ≤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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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
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 endpointsMean weekly blood glucose concentrations.
Time frame:3 Months
change from baseline, improvement
HbA1c
Time frame:3 Months
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Provenance
Sources
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.