NCT01536665

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P50-P75 for phase_1 diabetes

Timeline
Completed

Started Feb 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

February 16, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 22, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

February 8, 2017

Status Verified

February 1, 2017

Enrollment Period

6 months

First QC Date

February 16, 2012

Last Update Submit

February 6, 2017

Conditions

DiabetesDiabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

  • Geometric mean glucagon concentration during hypoglycaemia (nadir glucose (target 2.5 mmol/L) )

    At week 4

Secondary Outcomes (3)

  • Geometric mean glucagon concentration at plasma glucose levels other than nadir

    At week 4

  • Geometric mean concentrations of adrenaline and noradrenaline at nadir

    At week 4

  • Time from termination of insulin infusion at nadir to reach plasma glucose 4.0

    At week 4

Study Arms (3)

Low

EXPERIMENTAL
Drug: liraglutideDrug: placebo

Medium

EXPERIMENTAL
Drug: liraglutideDrug: placebo

High

EXPERIMENTAL
Drug: liraglutideDrug: placebo

Interventions

liraglutideDRUG

Administered subcutaneously (s.c., under the skin) once daily for 4 weeks.

HighLowMedium
placeboDRUG

Administered subcutaneously (s.c., under the skin) once daily for 4 weeks.

HighLowMedium

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Graz, 8036, Austria

Location

Related 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. doi: 10.1007/s40262-016-0413-4.

    PMID: 27282158RESULT

  • 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.

    PMID: 25855340RESULT

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 1

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1Glucagon-Like PeptidesProglucagonGastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Global Clinical Registry (GCR,1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2012

First Posted

February 22, 2012

Study Start

February 1, 2012

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

February 8, 2017

Record last verified: 2017-02

Locations

AU(1)