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

NCT01722227 | Withdrawn Phase 3

• 2 other identifiers: 1964 Liraglutide ADA1-12-CT-20
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

• 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.

  3 Months

Secondary Outcomes (1)

• HbA1c

  3 Months

Study Arms (2)

Liraglutide 0.6mg

ACTIVE COMPARATOR

Daily Injection

Drug: Liraglutide

Placebo

PLACEBO COMPARATOR

Daily Injection

Drug: Placebo

Interventions

Liraglutide DRUG

Liraglutide 0.6mg

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 15 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University at Buffalo: lead
• American Diabetes Association: collaborator

Study Sites (1)

Diabetes-Endocrinology Center of WNY

Williamsville, New York, 14221, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Distinguished Professor of Medicine

Study Record Dates

• First Submitted: November 2, 2012
• First Posted: November 6, 2012
• Study Start: November 1, 2012
• Primary Completion: November 1, 2017
• Study Completion: May 1, 2018
• Last Updated: February 9, 2017

Record last verified: 2017-02

Locations

US (1)