Back to resultsThe Effect of Liraglutide Adjunct to Insulin on Glucagon Response to Hypoglycaemia in Subjects With Type 1 Diabetes
Primary Purpose
Diabetes, Diabetes Mellitus, Type 1
Status
Completed
Phase
Phase 1
Locations
Austria
Study Type
Interventional
Intervention
liraglutide
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes
Eligibility 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
Sites / Locations
- Novo Nordisk Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Low
Medium
High
Arm Description
Outcomes
Primary Outcome Measures
Geometric mean glucagon concentration during hypoglycaemia (nadir glucose (target 2.5 mmol/L) )
Secondary Outcome Measures
Geometric mean glucagon concentration at plasma glucose levels other than nadir
Geometric mean concentrations of adrenaline and noradrenaline at nadir
Time from termination of insulin infusion at nadir to reach plasma glucose 4.0
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01536665
Brief Title
The Effect of Liraglutide Adjunct to Insulin on Glucagon Response to Hypoglycaemia in Subjects With Type 1 Diabetes
Official Title
The Effect of Liraglutide Adjunct to Insulin on Glucagon Response to Hypoglycaemia in Subjects With Type 1 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 1
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low
Arm Type
Experimental
Arm Title
Medium
Arm Type
Experimental
Arm Title
High
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
liraglutide
Intervention Description
Administered subcutaneously (s.c., under the skin) once daily for 4 weeks.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Administered subcutaneously (s.c., under the skin) once daily for 4 weeks.
Primary Outcome Measure Information:
Title
Geometric mean glucagon concentration during hypoglycaemia (nadir glucose (target 2.5 mmol/L) )
Time Frame
At week 4
Secondary Outcome Measure Information:
Title
Geometric mean glucagon concentration at plasma glucose levels other than nadir
Time Frame
At week 4
Title
Geometric mean concentrations of adrenaline and noradrenaline at nadir
Time Frame
At week 4
Title
Time from termination of insulin infusion at nadir to reach plasma glucose 4.0
Time Frame
At week 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR,1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Graz
ZIP/Postal Code
8036
Country
Austria
12. IPD Sharing Statement
Citations:
PubMed Identifier
27282158
Citation
Mader JK, Jensen L, Ingwersen SH, Christiansen E, Heller S, Pieber TR. Pharmacokinetic Properties of Liraglutide as Adjunct to Insulin in Subjects with Type 1 Diabetes Mellitus. Clin Pharmacokinet. 2016 Nov;55(11):1457-1463. doi: 10.1007/s40262-016-0413-4.
Results Reference
result
PubMed Identifier
25855340
Citation
Pieber TR, Deller S, Korsatko S, Jensen L, Christiansen E, Madsen J, Heller SR. Counter-regulatory hormone responses to hypoglycaemia in people with type 1 diabetes after 4 weeks of treatment with liraglutide adjunct to insulin: a randomized, placebo-controlled, double-blind, crossover trial. Diabetes Obes Metab. 2015 Aug;17(8):742-50. doi: 10.1111/dom.12473. Epub 2015 May 20.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
The Effect of Liraglutide Adjunct to Insulin on Glucagon Response to Hypoglycaemia in Subjects With Type 1 Diabetes
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