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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by Kaleida Health
Sponsor:
Collaborator:
American Diabetes Association
Information provided by (Responsible Party):
Paresh Dandona, MD, Kaleida Health
ClinicalTrials.gov Identifier:
NCT01722227
First received: November 2, 2012
Last updated: November 5, 2012
Last verified: November 2012
  Purpose

This is the first prospective randomized double-blind placebo-controlled study to investigate the effect of a GLP-1 analog, specifically liraglutide, on blood glucose levels and variability in subjects with type 1 diabetes treated with insulin. Liraglutide is the preferred GLP-1 analog for this study because the pharmacokinetics and pharmacodynamics of the drug are consistent with a sustained duration of action. The current gold standard for management of type 1 diabetes is based on insulin replacement with novel analogs with specified pharmacodynamic profiles or with unique insulin delivery systems (insulin pump therapy). No other adjuvant therapy has demonstrated sustained benefit in this population. This study will also investigate the effect of liraglutide on suppression of glucagon secretion during meal challenges. This is of particular importance since, in the absence of insulin secretion from the β-cell, there is no paracrine inhibition of glucagon secretion by the α-cell. Dysregulation of glucagon secretion may impact the glycemic control and overall pathogenesis in those with type 1 diabetes. The use of CGM technology in this study will allow us to determine the rapidity, consistency, and sustainability of any response to liraglutide.


Condition Intervention Phase
Type 1 Diabetes
Drug: Liraglutide
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Anti-diabetic Effects of Liraglutide in Adolescents and Young Subjects With Type 1 Diabetes

Resource links provided by NLM:


Further study details as provided by Kaleida Health:

Primary Outcome Measures:
  • Mean weekly blood glucose concentrations. [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
    The primary endpoint of the study is to detect a difference between Liraglutide and placebo groups in the change from baseline in mean weekly blood glucose concentrations after 12 weeks of treatment.


Secondary Outcome Measures:
  • HbA1c [ Time Frame: 3 Months ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: November 2012
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Liraglutide 0.6mg
Daily Injection
Drug: Liraglutide
Placebo Comparator: Placebo
Daily Injection
Drug: Placebo

  Eligibility

Ages Eligible for Study:   15 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01722227

Contacts
Contact: Sonja Williams 716-626-7998
Contact: Jeanne Hejna 716-626-7998

Locations
United States, New York
Diabetes-Endocrinology Center of WNY Recruiting
Williamsville, New York, United States, 14221
Contact: Sonja Williams    716-626-7998      
Principal Investigator: Paresh Dandona, MBBS,PhD         
Sponsors and Collaborators
Kaleida Health
American Diabetes Association
  More Information

No publications provided

Responsible Party: Paresh Dandona, MD, Distinguished Professor of Medicine, Kaleida Health
ClinicalTrials.gov Identifier: NCT01722227     History of Changes
Other Study ID Numbers: 1964 Liraglutide ADA, 1-12-CT-20
Study First Received: November 2, 2012
Last Updated: November 5, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases
Hypoglycemic Agents
Liraglutide
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Incretins
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014