Efficacy and Safety of Liraglutide in Combination With Insulin Therapy Compared to Insulin Alone in Japanese Subjects With Type 2 Diabetes
NCT ID: NCT01572740
Last Updated: 2018-02-07
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
257 participants
INTERVENTIONAL
2012-04-05
2013-03-27
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety and Tolerability of Liraglutide in Japanese Subjects With Type 2 Diabetes
NCT01615978
A Trial Comparing the Safety and Efficacy of Semaglutide Once Weekly in Monotherapy or in Combination With One OAD in Japanese Subjects With Type 2 Diabetes
NCT02207374
A Study of LY2189265 in Japanese Participants With Type 2 Diabetes Mellitus
NCT01558271
Safety and Efficacy of Oral Semaglutide Versus Dulaglutide Both in Combination With One OAD (Oral Antidiabetic Drug) in Japanese Subjects With Type 2 Diabetes
NCT03015220
A Research Study of How the Medicine NNC0480-0389 Taken With Semaglutide Works in the Body of Healthy Japanese Men
NCT04878406
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Lira+Insulin
liraglutide
Liraglutide administered subcutaneously (s.c., under the skin) for 36 weeks combined with insulin therapy.
insulin
All subjects will continue their pre-trial insulin therapy (basal, premixed or basal-bolus regimen) during the trial. Insulin dose is fixed for the first 16 weeks and for the subsequent 20 weeks, insulin dose is individually adjusted.
Placebo+Insulin
placebo
Liraglutide placebo administered subcutaneously (s.c., under the skin) for 36 weeks combined with insulin therapy.
insulin
All subjects will continue their pre-trial insulin therapy (basal, premixed or basal-bolus regimen) during the trial. Insulin dose is fixed for the first 16 weeks and for the subsequent 20 weeks, insulin dose is individually adjusted.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
liraglutide
Liraglutide administered subcutaneously (s.c., under the skin) for 36 weeks combined with insulin therapy.
placebo
Liraglutide placebo administered subcutaneously (s.c., under the skin) for 36 weeks combined with insulin therapy.
insulin
All subjects will continue their pre-trial insulin therapy (basal, premixed or basal-bolus regimen) during the trial. Insulin dose is fixed for the first 16 weeks and for the subsequent 20 weeks, insulin dose is individually adjusted.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Current insulin therapy (basal insulin, premixed insulin or basal-bolus regimen) in addition to diet and exercise therapy for at least 12 weeks prior to trial start. Their therapy is stable and fluctuation of total daily insulin dose is within plus/minus 20% for at least 12 weeks prior to trial start and current total daily insulin dose equal to or greater than 10 (I)U/day
* Glycosylated haemoglobin (HbA1c) between 7.5 and 11.0% (both inclusive)
* Body Mass Index (BMI) below 45.0 kg/m\^2
Exclusion Criteria
* Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic episode during last 12 months) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months
* Known proliferative retinopathy or maculopathy requiring treatment according to the investigator
* Treatment with glucagon-like peptide-1 (GLP-1) receptor agonist within 12 weeks prior to screening
* Treatment with any oral antidiabetic drugs (OADs) within 12 weeks prior to screening
20 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novo Nordisk A/S
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Novo Nordisk Investigational Site
Chuo-ku, Tokyo, , Japan
Novo Nordisk Investigational Site
Ebina-shi, Kanagawa, , Japan
Novo Nordisk Investigational Site
Ebina-shi, , Japan
Novo Nordisk Investigational Site
Kashiwara-shi, Osaka, , Japan
Novo Nordisk Investigational Site
Katsushika-ku, Tokyo, , Japan
Novo Nordisk Investigational Site
Koriyama-shi, Fukushima, , Japan
Novo Nordisk Investigational Site
Miyazaki, , Japan
Novo Nordisk Investigational Site
Naka-shi, Ibaraki, , Japan
Novo Nordisk Investigational Site
Niigata-shi, Niigata, , Japan
Novo Nordisk Investigational Site
Nishinomiya-shi, Hygo, , Japan
Novo Nordisk Investigational Site
Okawa-shi, Fukuoka, , Japan
Novo Nordisk Investigational Site
Osaka-shi, Osaka, , Japan
Novo Nordisk Investigational Site
Ota-ku, Tokyo, , Japan
Novo Nordisk Investigational Site
Oyama-shi, Tochigi, , Japan
Novo Nordisk Investigational Site
Ōita, , Japan
Novo Nordisk Investigational Site
Sapporo-shi, Hokkaido, , Japan
Novo Nordisk Investigational Site
Sapporo-shi, Hokkaido, , Japan
Novo Nordisk Investigational Site
Sendai, , Japan
Novo Nordisk Investigational Site
Shimotsuke-shi, Tochigi, , Japan
Novo Nordisk Investigational Site
Shizuoka, , Japan
Novo Nordisk Investigational Site
Takatsuki-shi, Osaka, , Japan
Novo Nordisk Investigational Site
Tokyo, , Japan
Novo Nordisk Investigational Site
Yokohama, , Japan
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Seino Y, Kaneko S, Fukuda S, Osonoi T, Shiraiwa T, Nishijima K, Bosch-Traberg H, Kaku K. Combination therapy with liraglutide and insulin in Japanese patients with type 2 diabetes: A 36-week, randomized, double-blind, parallel-group trial. J Diabetes Investig. 2016 Jul;7(4):565-73. doi: 10.1111/jdi.12457. Epub 2016 Jan 23.
Kaneko S, Nishijima K, Bosch-Traberg H, Kaku K, Seino Y. Efficacy and safety of adding liraglutide to existing insulin regimens in Japanese patients with type 2 diabetes mellitus: A post-hoc analysis of a phase 3 randomized clinical trial. J Diabetes Investig. 2018 Jul;9(4):840-849. doi: 10.1111/jdi.12793. Epub 2018 Feb 5.
Related Links
Access external resources that provide additional context or updates about the study.
Clinical Trials at Novo Nordisk
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
U1111-1122-4320
Identifier Type: OTHER
Identifier Source: secondary_id
JapicCTI-121802
Identifier Type: OTHER
Identifier Source: secondary_id
NN2211-3925
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.