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The Effect of Liraglutide Adjunct to Insulin on Glucagon Response to Hypoglycaemia in Subjects With Type 1 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01536665
First received: February 16, 2012
Last updated: August 21, 2012
Last verified: August 2012
History of Changes
  Purpose

This trial is conducted in Europe. The aim of this trial is to investigate if liraglutide adjunct to insulin treatment changes the glucagon response during hypoglycaemia in subjects with type 1 diabetes compared with conventional insulin treatment after 4 weeks' treatment with liraglutide or placebo.

Subjects will initially be randomised to one of the three dose groups, and subsequently randomly allocated to one of two treatment sequences (liraglutide/placebo or placebo/liraglutide).


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 1
 Drug: liraglutide
Drug: placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Liraglutide Adjunct to Insulin on Glucagon Response to Hypoglycaemia in Subjects With Type 1 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • Geometric mean glucagon concentration during hypoglycaemia (nadir glucose (target 2.5 mmol/L)) [ Time Frame: At week 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Geometric mean glucagon concentration at plasma glucose levels other than nadir [ Time Frame: At week 4 ] [ Designated as safety issue: No ]
  • Geometric mean concentrations of adrenaline and noradrenaline at nadir [ Time Frame: At week 4 ] [ Designated as safety issue: No ]
  • Time from termination of insulin infusion at nadir to reach plasma glucose 4.0 [ Time Frame: At week 4 ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: February 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low Drug: liraglutide
Administered subcutaneously (s.c., under the skin) once daily for 4 weeks.
Drug: placebo
Administered subcutaneously (s.c., under the skin) once daily for 4 weeks.
Experimental: Medium Drug: liraglutide
Administered subcutaneously (s.c., under the skin) once daily for 4 weeks.
Drug: placebo
Administered subcutaneously (s.c., under the skin) once daily for 4 weeks.
Experimental: High Drug: liraglutide
Administered subcutaneously (s.c., under the skin) once daily for 4 weeks.
Drug: placebo
Administered subcutaneously (s.c., under the skin) once daily for 4 weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months prior to randomisation
  • Body mass index (BMI) between 20.0 and 28.0 kg/m^2 (both inclusive)

Exclusion Criteria:

  • Use of liraglutide or exenatide within 3 months of randomisation
  • Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the trial physician or hospitalisation for diabetic ketoacidosis during the previous 6 months
  • Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01536665

Locations
Austria
Graz, Austria, 8036
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Lene Jensen Novo Nordisk
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Novo Nordisk
ClinicalTrials.gov Identifier: NCT01536665     History of Changes
Other Study ID Numbers: NN9211-3953, U1111-1123-9882, 2011-004240-22
Study First Received: February 16, 2012
Last Updated: August 21, 2012
Health Authority: Austria: The Austrian Agency for Health and Food Safety (AGES)

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
 Glucagon
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 13, 2013