Safety and Tolerability of Liraglutide in Japanese Subjects With Type 2 Diabetes
NCT ID: NCT01615978
Last Updated: 2017-01-25
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
15 participants
INTERVENTIONAL
2003-12-31
2004-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Fixed dose: 5 mcg/kg
liraglutide
5 mcg/kg daily for 14 days. Injected subcutaneously once daily
placebo
Liraglutide placebo administered to subjects randomised at each dose level in the ratio of 3:1
Escalated dose: 10 mcg/kg
liraglutide
Initial dose of 5 mcg/kg for 7 days followed by 10 mcg/kg for 7 days. Injected subcutaneously once daily
placebo
Liraglutide placebo administered to subjects randomised at each dose level in the ratio of 3:1
Interventions
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liraglutide
5 mcg/kg daily for 14 days. Injected subcutaneously once daily
liraglutide
Initial dose of 5 mcg/kg for 7 days followed by 10 mcg/kg for 7 days. Injected subcutaneously once daily
placebo
Liraglutide placebo administered to subjects randomised at each dose level in the ratio of 3:1
Eligibility Criteria
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Inclusion Criteria
* Duration of diabetes for more than 12 weeks
* Subjects currently on diet therapy (OHA-naïve) or treated with OHA (oral hypoglycaemic agent)
* monotherapy for more than 12 weeks
* HbA1c (Glycated haemoglobin A1c) between 6.0-9.0 %, both inclusive
* Body Mass Index (BMI): 18.5-30.0 kg/m\^2
Exclusion Criteria
* Proliferative retinopathy or maculopathy requiring acute treatment
* Impaired hepatic function
* Impaired renal function
* Cardiac problems
* Uncontrolled treated/untreated hypertension
* Current treatment with insulin preparations or TZDs (thiazolidinediones)
* Current treatment or expected at the screening to start treatment with systemic corticosteroids
20 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
Tokyo, , Japan
Countries
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References
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Kageyama S, Hirao K, Shimizu A, Matsumura Y, Zdravkovic M, Rasmussen MF, Irie S. Tolerability, pharmacokinetics, and pharmacodynamics of liraglutide, long-acting human GLP-1 analogue - Phase 1 studies in Japanese healthy subjects with type 2 diabetes. Endocrinology and Diabetology 2007; 24 (6): 95-104
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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NN2211-1591
Identifier Type: -
Identifier Source: org_study_id
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