Anti-diabetic Effects of Liraglutide in Adolescents and Young Subjects With Type 1 Diabetes
Primary Purpose
Type 1 Diabetes
Status
Withdrawn
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Liraglutide
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes
Eligibility Criteria
Inclusion Criteria:
INCLUSION CRITERIA:
- Females and males with Type 1 diabetes as ascertained by islet autoantibodies (GAD-65 and/or islet cell antibodies)
- 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.
- Type 1 diabetes duration greater than 1 year to ensure that a majority of subjects are beyond the partial remission period.
- Fasting C-peptide level ≤ 0.3 ng/ml.
- HbA1c level equal or less than 9%
- 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.
- Subjects willing to wear a CGM sensor and perform home blood glucose monitoring four times daily and with symptoms of hypoglycemia.
- Subjects well-versed in carbohydrate counting.
- BMI < 95th% for age and gender.
Exclusion Criteria:
EXCLUSION CRITERIA:
- Previous exposure to liraglutide
- History of abdominal surgery
- History of gastroparesis or gastrointestinal reflux disease;
- History of acute or chronic pancreatitis
- Cirrhosis or hepatic disease defined as transaminases levels > 3 times normal
- Impaired renal function defined as serum creatinine >1.5.
- HIV or Hepatitis C positive status
- Pregnant/breastfeeding females
- Individuals with steroid-induced or cystic fibrosis related diabetes
- Diabetic Ketoacidosis within 6 months of the study
- History of severe hypoglycemia (seizure, loss of consciousness) within 6 months of the study
- History of medullary thyroid cancer or MEN2 syndrome
- Any other life-threatening cardiac or non-cardiac disease
- Participation in a concurrent clinical trial or participation in a trial within 30 days preceding the study period.
- Unable to give informed consent/assent.
Adolescents and adults who are considered underweight based on body mass index (BMI):
- For adolescents: BMI less than the 5th percentile
- For adults: BMI below 18.5
Sites / Locations
- Diabetes-Endocrinology Center of WNY
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Liraglutide 0.6mg
Placebo
Arm Description
Daily Injection
Daily Injection
Outcomes
Primary Outcome Measures
Mean weekly blood glucose concentrations.
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
Full Information
NCT ID
NCT01722227
First Posted
November 2, 2012
Last Updated
February 8, 2017
Sponsor
University at Buffalo
Collaborators
American Diabetes Association
1. Study Identification
Unique Protocol Identification Number
NCT01722227
Brief Title
Anti-diabetic Effects of Liraglutide in Adolescents and Young Subjects With Type 1 Diabetes
Official Title
Anti-diabetic Effects of Liraglutide in Adolescents and Young Subjects With Type 1 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Withdrawn
Why Stopped
No Funding Received from ADA
Study Start Date
November 2012 (undefined)
Primary Completion Date
November 2017 (Anticipated)
Study Completion Date
May 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University at Buffalo
Collaborators
American Diabetes Association
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Liraglutide 0.6mg
Arm Type
Active Comparator
Arm Description
Daily Injection
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Daily Injection
Intervention Type
Drug
Intervention Name(s)
Liraglutide
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Mean weekly blood glucose concentrations.
Description
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.
Time Frame
3 Months
Secondary Outcome Measure Information:
Title
HbA1c
Time Frame
3 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
INCLUSION CRITERIA:
Females and males with Type 1 diabetes as ascertained by islet autoantibodies (GAD-65 and/or islet cell antibodies)
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.
Type 1 diabetes duration greater than 1 year to ensure that a majority of subjects are beyond the partial remission period.
Fasting C-peptide level ≤ 0.3 ng/ml.
HbA1c level equal or less than 9%
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.
Subjects willing to wear a CGM sensor and perform home blood glucose monitoring four times daily and with symptoms of hypoglycemia.
Subjects well-versed in carbohydrate counting.
BMI < 95th% for age and gender.
Exclusion Criteria:
EXCLUSION CRITERIA:
Previous exposure to liraglutide
History of abdominal surgery
History of gastroparesis or gastrointestinal reflux disease;
History of acute or chronic pancreatitis
Cirrhosis or hepatic disease defined as transaminases levels > 3 times normal
Impaired renal function defined as serum creatinine >1.5.
HIV or Hepatitis C positive status
Pregnant/breastfeeding females
Individuals with steroid-induced or cystic fibrosis related diabetes
Diabetic Ketoacidosis within 6 months of the study
History of severe hypoglycemia (seizure, loss of consciousness) within 6 months of the study
History of medullary thyroid cancer or MEN2 syndrome
Any other life-threatening cardiac or non-cardiac disease
Participation in a concurrent clinical trial or participation in a trial within 30 days preceding the study period.
Unable to give informed consent/assent.
Adolescents and adults who are considered underweight based on body mass index (BMI):
For adolescents: BMI less than the 5th percentile
For adults: BMI below 18.5
Facility Information:
Facility Name
Diabetes-Endocrinology Center of WNY
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Anti-diabetic Effects of Liraglutide in Adolescents and Young Subjects With Type 1 Diabetes
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