The Efficacy and Safety Study in Patients With Type 2 Diabetes Mellitus
NCT ID: NCT01608724
Last Updated: 2016-02-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
2165 participants
INTERVENTIONAL
2012-11-30
2014-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Open label
Saxagliptin, oral 5mg once a day(Q. D.)
Saxagliptin
oral, 5 mg once a day (Q.D.)
Interventions
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Saxagliptin
oral, 5 mg once a day (Q.D.)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Men or women who are \>18 years of age at time of consenting upon Visit 1
* HbA1c \>7.5% and ≤11.0% Patients should be drug naive or treated with metformin alone on stable doses of for at least continues 8 weeks prior to Visit 1
* Drug naive patients are defined as patients who have not received medical treatment for diabetes (insulin and/or oral hypo)
Exclusion Criteria
* Insulin therapy within one year of enrolment (with the exception of insulin therapy during a hospitalization or use in gestational diabetes)
* Previous treatment with any DPP-IV inhibitors or GLP-1 analogue
* History of administration of any antihyperglycemic therapy (other than metformin) during the 8 weeks prior to Visit 1(12 weeks for previous TZD)
* Treatment with systemic glucocorticoids other than replacement therapy
* Inhaled, local injected and topical use of glucocorticoids is allowed
18 Years
99 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Simon Fisher
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Baotou, , China
Research Site
Beijing, , China
Research Site
Benxi, , China
Research Site
Changchun, , China
Research Site
Chengdu, , China
Research Site
Chongqing, , China
Research Site
Dalian, , China
Research Site
Dongguan, , China
Research Site
Foshan, , China
Research Site
Fuzhou, , China
Research Site
Guangzhou, , China
Research Site
Guiyang, , China
Research Site
Haikou, , China
Research Site
Hangzhou, , China
Research Site
Hhht, , China
Research Site
Hubei, , China
Research Site
Jimo, , China
Research Site
Jinan, , China
Research Site
Kunming, , China
Research Site
Linyi, , China
Research Site
Nanjing, , China
Research Site
Nantong, , China
Research Site
Qingdao, , China
Research Site
Shanghai, , China
Research Site
Shantou, , China
Research Site
Shenyang, , China
Research Site
Shiyan, , China
Research Site
Suzhou, , China
Research Site
Taiyuan, , China
Research Site
Tianjin, , China
Research Site
Ürümqi, , China
Research Site
Wenzhou, , China
Research Site
Wuhan, , China
Research Site
Wuxi, , China
Research Site
Xi'an, , China
Research Site
Zhanjiang, , China
Research Site
Zhengzhou, , China
Countries
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Other Identifiers
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D1680L00008
Identifier Type: -
Identifier Source: org_study_id
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