Effect of Liraglutide on Blood Glucose Control in Japanese Subjects With Type 2 Diabetes
Effect of Liraglutide on Glycaemic Control in Japanese Subjects With Type 2 Diabetes.
2 other identifiers
interventional
226
1 country
1
Brief Summary
This trial is conducted in Japan. The aim of this research trial is to evaluate the effect of treatment with liraglutide or placebo on blood glucose control after 14 weeks in Japanese subjects with type 2 diabetes. Liraglutide or placebo is administered by injection once daily in the evening. The trial is a multi-national trial with treatment concealed to participating subjects, investigators and the sponsor. Treatment allocation is random with equal chance of being assigned to each group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 diabetes
Started Jan 2005
1 active site
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
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 8, 2005
CompletedFirst Posted
Study publicly available on registry
September 12, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2006
CompletedJanuary 25, 2017
January 1, 2017
1.3 years
September 8, 2005
January 24, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
HbA1c
after 14 weeks treatment
Secondary Outcomes (3)
Glycaemic control parameters (fasting plasma glucose, post prandial plasma glucose) after 14-week treatment
Body weight after 14 weeks.
Safety and tolerability
Interventions
Eligibility Criteria
You may qualify if:
- Subjects diagnosed with type 2 diabetes and treated with diet therapy with or without single oral drug therapy
- % =\< HbA1c \< 10.0 %
- Body Mass Index (BMI) \< 30.0 kg/m\^2
You may not qualify if:
- Subjects treated with thiazolidinediones or insulin
- Subjects with any serious medical conditions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (1)
Novo Nordisk Investigational Site
Tokyo, 1000005, Japan
Related Publications (2)
Seino Y, Rasmussen MF, Zdravkovic M, Kaku K. Dose-dependent improvement in glycemia with once-daily liraglutide without hypoglycemia or weight gain: A double-blind, randomized, controlled trial in Japanese patients with type 2 diabetes. Diabetes Res Clin Pract. 2008 Aug;81(2):161-8. doi: 10.1016/j.diabres.2008.03.018. Epub 2008 May 20.
PMID: 18495285RESULTJensen TM, Saha K, Steinberg WM. Is there a link between liraglutide and pancreatitis? A post hoc review of pooled and patient-level data from completed liraglutide type 2 diabetes clinical trials. Diabetes Care. 2015 Jun;38(6):1058-66. doi: 10.2337/dc13-1210. Epub 2014 Dec 12.
PMID: 25504028RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 8, 2005
First Posted
September 12, 2005
Study Start
January 1, 2005
Primary Completion
May 1, 2006
Study Completion
May 1, 2006
Last Updated
January 25, 2017
Record last verified: 2017-01