Effect of Liraglutide on Blood Glucose Control in Subjects With Type 2 Diabetes
NCT ID: NCT00393718
Last Updated: 2017-03-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
400 participants
INTERVENTIONAL
2006-11-30
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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Liraglutide
Liraglutide 0.9 mg + glibenclamide placebo
liraglutide
0.9 mg/day. Injected s.c. (under the skin) once daily.
placebo
glibenclamide placebo. Given orally once or twice daily.
Glibenclamide
Glibenclamide 1.25-2.5 mg + liraglutide placebo
glibenclamide
1.25-2.5 mg tablet. Given orally once or twice daily.
placebo
liraglutide placebo. Injected s.c. (under the skin) once daily.
Interventions
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liraglutide
0.9 mg/day. Injected s.c. (under the skin) once daily.
glibenclamide
1.25-2.5 mg tablet. Given orally once or twice daily.
placebo
liraglutide placebo. Injected s.c. (under the skin) once daily.
placebo
glibenclamide placebo. Given orally once or twice daily.
Eligibility Criteria
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Inclusion Criteria
* Diet/exercise therapy with or without an oral anti-diabetic drug for at least eight weeks
* HbA1c greater than or equal to 7.0% and less than 10.0%
* BMI (Body Mass Index) 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, Nishida T, Kaku K. Efficacy and safety of the once-daily human GLP-1 analogue, liraglutide, vs glibenclamide monotherapy in Japanese patients with type 2 diabetes. Curr Med Res Opin. 2010 May;26(5):1013-22. doi: 10.1185/03007991003672551.
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.
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.
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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NN2211-1700
Identifier Type: -
Identifier Source: org_study_id
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