The Effect of Liraglutide Adjunct to Insulin on Glucagon Response to Hypoglycaemia in Subjects With Type 1 Diabetes
NCT ID: NCT01536665
Last Updated: 2017-02-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
45 participants
INTERVENTIONAL
2012-02-29
2012-08-31
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Low
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.
Medium
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.
High
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Body mass index (BMI) between 20.0 and 28.0 kg/m\^2 (both inclusive)
Exclusion Criteria
* 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
18 Years
64 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR,1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Graz, , Austria
Countries
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References
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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.
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.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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U1111-1123-9882
Identifier Type: OTHER
Identifier Source: secondary_id
2011-004240-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NN9211-3953
Identifier Type: -
Identifier Source: org_study_id
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