Effect of Liraglutide or Glimepiride Added to Metformin on Blood Glucose Control in Subjects With Type 2 Diabetes
NCT ID: NCT00614120
Last Updated: 2017-03-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
929 participants
INTERVENTIONAL
2008-01-31
2009-02-28
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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Lira 0.6 + Met
Liraglutide 0.6 mg + metformin + glimepiride placebo
liraglutide
0.6 mg/day, s.c. (under the skin) injection
placebo
Glimepiride placebo, capsules
metformin
Tablets, 1.5-2.0 g/day
Lira 1.2 + Met
Liraglutide 1.2 mg + metformin + glimepiride placebo
placebo
Glimepiride placebo, capsules
liraglutide
1.2 mg/day, s.c. (under the skin) injection
metformin
Tablets, 1.5-2.0 g/day
Lira 1.8 + Met
Liraglutide + metformin + glimepiride placebo
placebo
Glimepiride placebo, capsules
liraglutide
1.8 mg/day, s.c. (under the skin) injection
metformin
Tablets, 1.5-2.0 g/day
Glim + Met
Glimepiride 4.0 mg + metformin + liraglutide placebo
glimepiride
Capsules, 4.0 mg/day
metformin
Tablets, 1.5-2.0 g/day
placebo
Liraglutide placebo, s.c. (under the skin) injection
Interventions
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liraglutide
0.6 mg/day, s.c. (under the skin) injection
placebo
Glimepiride placebo, capsules
liraglutide
1.2 mg/day, s.c. (under the skin) injection
liraglutide
1.8 mg/day, s.c. (under the skin) injection
glimepiride
Capsules, 4.0 mg/day
metformin
Tablets, 1.5-2.0 g/day
placebo
Liraglutide placebo, s.c. (under the skin) injection
Eligibility Criteria
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Inclusion Criteria
* Subjects diagnosed with type 2 diabetes and treated with one or more oral antidiabetic drugs (OADs) for the last 3 months
* HbA1c: 7.0-11.0% (both incl.) for subjects on OAD alone
* HbA1c: 7.0-10.0 % (both incl.) for subjects on OAD combination therapy
* BMI less than 45.0 kg/m\^2
Exclusion Criteria
* Impaired liver or/and renal function
* Significant cardiovascular disease over the last 6 months
* Known retinopathy or maculopathy
* Recurrent major hypoglycaemia or hypoglycaemic unawareness
18 Years
80 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), MD, PhD
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Beijing, Beijing Municipality, China
Novo Nordisk Investigational Site
Beijing, Beijing Municipality, China
Novo Nordisk Investigational Site
Chongqing, Chongqing Municipality, China
Novo Nordisk Investigational Site
Fuzhou, Fujian, China
Novo Nordisk Investigational Site
Harbin, Heilongjiang, China
Novo Nordisk Investigational Site
Harbin, Heilongjiang, China
Novo Nordisk Investigational Site
Wuhan, Hubei, China
Novo Nordisk Investigational Site
Nanjing, Jiangsu, China
Novo Nordisk Investigational Site
Suzhou, Jiangsu, China
Novo Nordisk Investigational Site
Wuxi, Jiangsu, China
Novo Nordisk Investigational Site
Xi'an, Shaanxi, China
Novo Nordisk Investigational Site
Shanghai, Shanghai Municipality, China
Novo Nordisk Investigational Site
Hangzhou, Zhejiang, China
Novo Nordisk Investigational Site
Shenyang, , China
Novo Nordisk Investigational Site
Tianjin, , China
Novo Nordisk Investigational Site
Wuhan, , China
Novo Nordisk Investigational Site
Hyderabad, Andhra Pradesh, India
Novo Nordisk Investigational Site
Hyderbad, Andhra Pradesh, India
Novo Nordisk Investigational Site
Ahmedabad, Gujarat, India
Novo Nordisk Investigational Site
Bangalore, Karnataka, India
Novo Nordisk Investigational Site
Kochi, Kerala, India
Novo Nordisk Investigational Site
Mumbai, Maharashtra, India
Novo Nordisk Investigational Site
Pune, Maharashtra, India
Novo Nordisk Investigational Site
New Dehli, New Delhi, India
Novo Nordisk Investigational Site
Bhubaneswar, Odisha, India
Novo Nordisk Investigational Site
Jaipur, Rajasthan, India
Novo Nordisk Investigational Site
Chennai, Tamil Nadu, India
Novo Nordisk Investigational Site
Madurai, Tamil Nadu, India
Novo Nordisk Investigational Site
Kolkata, West Bengal, India
Novo Nordisk Investigational Site
Ghaziabad, , India
Novo Nordisk Investigational Site
Kochi, , India
Novo Nordisk Investigational Site
Kolkata, , India
Novo Nordisk Investigational Site
Kolkata, , India
Novo Nordisk Investigational Site
Mumbai, , India
Novo Nordisk Investigational Site
Mumbai, , India
Novo Nordisk Investigational Site
New Delhi, , India
Novo Nordisk Investigational Site
Patna, , India
Novo Nordisk Investigational Site
Secunderabad, , India
Novo Nordisk Investigational Site
Trivandrum, , India
Novo Nordisk Investigational Site
Visakhapatnam, , India
Novo Nordisk Investigational Site
Goyang, , South Korea
Novo Nordisk Investigational Site
Incheon, , South Korea
Novo Nordisk Investigational Site
Seoul, , South Korea
Novo Nordisk Investigational Site
Seoul, , South Korea
Novo Nordisk Investigational Site
Seoul, , South Korea
Novo Nordisk Investigational Site
Seoul, , South Korea
Novo Nordisk Investigational Site
Seoul, , South Korea
Novo Nordisk Investigational Site
Seoul, , South Korea
Novo Nordisk Investigational Site
Sungnam, , South Korea
Novo Nordisk Investigational Site
Suwon, , South Korea
Countries
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References
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Yang W, Chen L, Ji Q, Liu X, Ma J, Tandon N, Bhattacharyya A, Kumar A, Kim KW, Yoon KH, Bech OM, Zychma M. Liraglutide provides similar glycaemic control as glimepiride (both in combination with metformin) and reduces body weight and systolic blood pressure in Asian population with type 2 diabetes from China, South Korea and India: a 16-week, randomized, double-blind, active control trial(*). Diabetes Obes Metab. 2011 Jan;13(1):81-8. doi: 10.1111/j.1463-1326.2010.01323.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.
Ingwersen SH, Petri KC, Tandon N, Yoon KH, Chen L, Vora J, Yang W. Liraglutide pharmacokinetics and dose-exposure response in Asian subjects with Type 2 diabetes from China, India and South Korea. Diabetes Res Clin Pract. 2015 Apr;108(1):113-9. doi: 10.1016/j.diabres.2015.01.001. Epub 2015 Jan 19.
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.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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NN2211-1796
Identifier Type: -
Identifier Source: org_study_id
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