52 Week Trial of Liraglutide in Type 1 Diabetes (LIDO)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Québec, CHU de Québec
ClinicalTrials.gov Identifier:
NCT01787916
First received: February 4, 2013
Last updated: March 17, 2014
Last verified: March 2014
  Purpose

To our knowledge, no trial has specifically studied the effect of liraglutide combined with a basal/bolus insulin regimen in type 1 diabetes in a cross-over, double-blind, unicentric model. Moreover, the potential impact of a glucagon-like peptide-1 agonist on measures of abdominal fat (assessed by CT scan), insulin sensitivity (assessed by the gold standard euglycemic-hyperinsulinemic clamp) and satiety sensations have not been evaluated in this population.

Hypothesis Overweight participants with type 1 diabetes on liraglutide/insulin treatment will present improved glucose control with decreased HbA1c, decreased fasting and mean weekly glucose concentrations and glycemic excursions as well as increased insulin sensitivity compared to participants on placebo/insulin treatment. Participants with liraglutide/insulin treatment will also present improved endothelial function, lower body weight, central adipose tissue assessed by CT scan and higher satiety sensations assessed by visual analogue scales.


Condition Intervention Phase
Type 1 Diabetes
Drug: Liraglutide
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cross-over, Double-blind, Unicentric, 52 Week Trial of Liraglutide in Type 1 Diabetes.

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Québec, CHU de Québec:

Primary Outcome Measures:
  • Assessment of changes in glycemic control by HbA1c. [ Time Frame: Measure changes in HbA1c at 24 and 52 weeks from baseline ] [ Designated as safety issue: No ]
    To investigate the effect of 24 weeks of treatment with liraglutide combined with a basal/bolus insulin regimen in overweight participants with type 1 diabetes on glycemic control as assessed by HbA1c.


Secondary Outcome Measures:
  • Assessment of changes in various metabolic measures (composite) [ Time Frame: Measure changes in the composite at 24 and 52 weeks from baseline ] [ Designated as safety issue: No ]
    To investigate the effect of 24 weeks of treatment with liraglutide combined with the basal/bolus insulin regimen insulin on glycemic variation, risk of hypoglycemia, glucagon in blood, weight, body mass index (BMI), waist circumference, central adipose tissue area, satiety sensations, the presence of the metabolic syndrome and insulin sensitivity assessed by euglycemia-hyperinsulinemic clamp and estimated glucose disposal rate.


Estimated Enrollment: 15
Study Start Date: April 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Liraglutide
Liraglutide, s.c., 1.8 mg, die, 24 weeks
Drug: Liraglutide
Liraglutide will be compared to placebo for 24 weeks in a cross-over design
Other Names:
  • Liraglutide
  • Victoza
Placebo Comparator: Placebo
Placebo visually identical to study drug will be given
Drug: Liraglutide
Liraglutide will be compared to placebo for 24 weeks in a cross-over design
Other Names:
  • Liraglutide
  • Victoza

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • type 1 diabetes non smoker BMI superior or equal to 25 diabetes duration superior or equal to 5 years

Exclusion Criteria:

  • diabetic complication HbA1c superior or equal to 8.5% cancer acute or chronic pancreatitis
  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: NCT01787916

Locations
Canada
CHU de Québec
Quebec, Canada, G1V 4G2
Sponsors and Collaborators
Centre Hospitalier Universitaire de Québec, CHU de Québec
Novo Nordisk A/S
Investigators
Principal Investigator: Stanley John Weisnagel, MD CHU de Québec
Principal Investigator: Martin D'Amours, MD CHU de Québec
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Québec, CHU de Québec
ClinicalTrials.gov Identifier: NCT01787916     History of Changes
Other Study ID Numbers: 2013LIDO
Study First Received: February 4, 2013
Last Updated: March 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Centre Hospitalier Universitaire de Québec, CHU de Québec:
type 1 diabetes
overweight
insulin
liraglutide

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

ClinicalTrials.gov processed this record on September 18, 2014