Effect of Liraglutide in Combination With Sulfonylurea (SU) on Blood Glucose Control in Subjects With Type 2 Diabetes
NCT ID: NCT00395746
Last Updated: 2017-03-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
264 participants
INTERVENTIONAL
2006-10-31
2008-05-31
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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0.6 mg + SU
Liraglutide 0.6 mg + sulphonylurea
sulfonylurea
SU agent
liraglutide
Liraglutide 0.6 mg/day or placebo. Injected s.c. (under the skin) once daily.
0.9 mg + SU
Liraglutide 0.9 mg + sulphonylurea
sulfonylurea
SU agent
liraglutide
Liraglutide 0.9 mg/day or placebo. Injected s.c. (under the skin) once daily.
SU Mono - 1
Liraglutide placebo 0.6 mg + sulphonylurea
sulfonylurea
SU agent
SU Mono - 2
Liraglutide placebo 0.9 mg + sulphonylurea
sulfonylurea
SU agent
Interventions
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sulfonylurea
SU agent
liraglutide
Liraglutide 0.6 mg/day or placebo. Injected s.c. (under the skin) once daily.
liraglutide
Liraglutide 0.9 mg/day or placebo. Injected s.c. (under the skin) once daily.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
20 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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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.
Kaku 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.
Alves 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.
Jensen 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.
Buse 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.
Hegedus 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.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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JapicCTI-060324
Identifier Type: REGISTRY
Identifier Source: secondary_id
NN2211-1701
Identifier Type: -
Identifier Source: org_study_id
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