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

February 6, 2017 updated by: Novo Nordisk A/S

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8036
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Geometric mean glucagon concentration during hypoglycaemia (nadir glucose (target 2.5 mmol/L) )
Time Frame: At week 4
At week 4

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

February 16, 2012

First Submitted That Met QC Criteria

February 16, 2012

First Posted (Estimate)

February 22, 2012

Study Record Updates

Last Update Posted (Estimate)

February 8, 2017

Last Update Submitted That Met QC Criteria

February 6, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN9211-3953
  • U1111-1123-9882 (Other Identifier: WHO)
  • 2011-004240-22 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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