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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:
ClinicalTrials.gov Identifier:
NCT01536665
First Posted: February 22, 2012
Last Update Posted: February 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  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
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Geometric mean glucagon concentration during hypoglycaemia (nadir glucose (target 2.5 mmol/L) ) [ Time Frame: At week 4 ]

Secondary Outcome Measures:
  • Geometric mean glucagon concentration at plasma glucose levels other than nadir [ Time Frame: At week 4 ]
  • Geometric mean concentrations of adrenaline and noradrenaline at nadir [ Time Frame: At week 4 ]
  • Time from termination of insulin infusion at nadir to reach plasma glucose 4.0 [ Time Frame: At week 4 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01536665


Locations
Austria
Novo Nordisk Investigational Site
Graz, Austria, 8036
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR,1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01536665     History of Changes
Other Study ID Numbers: NN9211-3953
U1111-1123-9882 ( Other Identifier: WHO )
2011-004240-22 ( EudraCT Number )
First Submitted: February 16, 2012
First Posted: February 22, 2012
Last Update Posted: February 8, 2017
Last Verified: February 2017

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