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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01536665
• Other study ID #: NN9211-3953
• Secondary ID: U1111-1123-98822
• Status: Completed
• Phase: Phase 1
• First received: February 16, 2012
• Last updated: February 6, 2017
• Start date: February 2012
• Est. completion date: August 2012

Study information

• Verified date: February 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Hypoglycemia

Intervention

Drug:
• liraglutide
Administered subcutaneously (s.c., under the skin) once daily for 4 weeks.
• placebo
Administered subcutaneously (s.c., under the skin) once daily for 4 weeks.

Locations

Country	Name	City	State
Austria	Novo Nordisk Investigational Site	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Austria, 

References & Publications (2)

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. — View 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-cont — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Geometric mean glucagon concentration during hypoglycaemia (nadir glucose (target 2.5 mmol/L) )		At week 4
Secondary	Geometric mean glucagon concentration at plasma glucose levels other than nadir		At week 4
Secondary	Geometric mean concentrations of adrenaline and noradrenaline at nadir		At week 4
Secondary	Time from termination of insulin infusion at nadir to reach plasma glucose 4.0		At week 4

External Links

•   Clinical Trials at Novo Nordisk