Effect of Liraglutide in Combination With Sulfonylurea (SU) on Blood Glucose Control in Subjects With Type 2 Diabetes
2 other identifiers
interventional
264
1 country
1
Brief Summary
This trial is conducted in Japan. The trial aims for comparison of the effect on glycaemic control of liraglutide in combination with sulphonylurea agent (SU) compared to SU monotherapy, as assessed by HbA1c after 24 weeks and 52 weeks in subjects with type 2 diabetes. Liraglutide will be compared to placebo, in combination with SU. Trial has a randomisation period of 24 weeks followed by a 28 week extension period, in total 52 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 diabetes
Started Oct 2006
Typical duration for phase_3 diabetes
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
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
November 2, 2006
CompletedFirst Posted
Study publicly available on registry
November 3, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedResults Posted
Study results publicly available
March 12, 2010
CompletedMarch 8, 2017
January 1, 2017
1 year
November 2, 2006
February 23, 2010
January 25, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Glycosylated Haemoglobin A1c (HbA1c) After 24 Weeks of Treatment
after 24 weeks of treatment
Secondary Outcomes (12)
Glycosylated Haemoglobin A1c (HbA1c) After 52 Weeks of Treatment
after 52 weeks of treatment
Fasting Plasma Glucose After 24 Weeks of Treatment
after 24 weeks of treatment
Fasting Plasma Glucose After 52 Weeks of Treatment
after 52 weeks of treatment
Postprandial Glucose AUC After 24 Weeks of Treatment
after 24 weeks of treatment
Postprandial Glucose AUC After 52 Weeks of Treatment
after 52 weeks of treatment
- +7 more secondary outcomes
Study Arms (4)
0.6 mg + SU
EXPERIMENTALLiraglutide 0.6 mg + sulphonylurea
0.9 mg + SU
EXPERIMENTALLiraglutide 0.9 mg + sulphonylurea
SU Mono - 1
PLACEBO COMPARATORLiraglutide placebo 0.6 mg + sulphonylurea
SU Mono - 2
PLACEBO COMPARATORLiraglutide placebo 0.9 mg + sulphonylurea
Interventions
Liraglutide 0.6 mg/day or placebo. Injected s.c. (under the skin) once daily.
Eligibility Criteria
You may qualify if:
- Type 2 diabetes
- Diet/exercise therapy with sulfonylurea (SU) for at least eight weeks
- HbA1c greater than or equal to 7.0% and less than 10.0%
- BMI less than 35 kg/m2
You may not qualify if:
- Treatment with insulin within the last 12 weeks
- Treatment with any drug that could interfere with the glucose level
- Any serious medical condition
- Females who are pregnant, have intention of becoming pregnant or are breastfeeding
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 (6)
Seino Y, Rasmussen MF, Clauson P, Kaku K. The once-daily human glucagon-like peptide-1 analog, liraglutide, improves beta-cell function in Japanese patients with type 2 diabetes. J Diabetes Investig. 2012 Aug 20;3(4):388-95. doi: 10.1111/j.2040-1124.2012.00193.x.
PMID: 24843595RESULTKaku K, Rasmussen MF, Clauson P, Seino Y. Improved glycaemic control with minimal hypoglycaemia and no weight change with the once-daily human glucagon-like peptide-1 analogue liraglutide as add-on to sulphonylurea in Japanese patients with type 2 diabetes. Diabetes Obes Metab. 2010 Apr;12(4):341-7. doi: 10.1111/j.1463-1326.2009.01194.x.
PMID: 20380655RESULTAlves C, Batel-Marques F, Macedo AF. A meta-analysis of serious adverse events reported with exenatide and liraglutide: acute pancreatitis and cancer. Diabetes Res Clin Pract. 2012 Nov;98(2):271-84. doi: 10.1016/j.diabres.2012.09.008. Epub 2012 Sep 23.
PMID: 23010561RESULTJensen 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: 25504028RESULTBuse JB, Garber A, Rosenstock J, Schmidt WE, Brett JH, Videbaek N, Holst J, Nauck M. Liraglutide treatment is associated with a low frequency and magnitude of antibody formation with no apparent impact on glycemic response or increased frequency of adverse events: results from the Liraglutide Effect and Action in Diabetes (LEAD) trials. J Clin Endocrinol Metab. 2011 Jun;96(6):1695-702. doi: 10.1210/jc.2010-2822. Epub 2011 Mar 30.
PMID: 21450987DERIVEDHegedus L, Moses AC, Zdravkovic M, Le Thi T, Daniels GH. GLP-1 and calcitonin concentration in humans: lack of evidence of calcitonin release from sequential screening in over 5000 subjects with type 2 diabetes or nondiabetic obese subjects treated with the human GLP-1 analog, liraglutide. J Clin Endocrinol Metab. 2011 Mar;96(3):853-60. doi: 10.1210/jc.2010-2318. Epub 2011 Jan 5.
PMID: 21209033DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Public Access to Clinical Trials
- Organization
- Novo Nordisk A/S
Study Officials
- STUDY DIRECTOR
Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 2006
First Posted
November 3, 2006
Study Start
October 1, 2006
Primary Completion
October 1, 2007
Study Completion
May 1, 2008
Last Updated
March 8, 2017
Results First Posted
March 12, 2010
Record last verified: 2017-01