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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ChiCTR |
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Last refreshed on:
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5 June 2017 |
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Main ID: |
ChiCTR-IOR-17011477 |
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Date of registration:
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2017-05-24 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Effect of saxagliptin and Metformin on bone metabolism in patients with newly diagnosed yype 2 diabetes
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Scientific title:
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Effect of saxagliptin and Metformin on bone metabolism in patients with newly diagnosed yype 2 diabetes |
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Date of first enrolment:
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2017-10-01 |
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Target sample size:
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saxagliptin group:30;Metformin group:30; |
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Recruitment status: |
Recruiting |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=18373 |
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Study type:
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Interventional study |
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Study design:
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Randomized parallel controlled trial
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Phase:
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Other
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Contacts
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Name:
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Yang Hangmei
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Address:
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156 North Second Ring Road, Fuzhou, Fujian, China
350500
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Telephone:
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+86 14759155773 |
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Email:
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1093865720@qq.com |
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Affiliation:
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Department of Endocrinology; Fuzhou General Hospital of Nanjing Military Area Command |
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Name:
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Xu Xiangjin
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Address:
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156 North Secondary Ring Road, Gulou District, Fuzhou, Fujian, China
350500
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Telephone:
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+86 14759155773 |
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Email:
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Xu98111@163.com |
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Affiliation:
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Department of Endocrinology; Fuzhou General Hospital of Nanjing Military Area Command |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1) patients with type 2 diabetes mellitus patients, selected in accordance with WHO diagnosis standard in 1999; 2) by the strict diet and exercise control, blood sugar is still not standard (HbA1c 7%~10%);
3) body mass index (BMI) was less than 30kg/ square meters, weight before screening fluctuation range is less than 10% and at least 3 months stability;
Exclusion criteria: 1) acute complications of type 1 diabetes or diabetes, due to pancreatic injury caused by diabetes or secondary diabetes);
2) patients had fractures, osteoporosis disease, is currently taking anti osteoporosis drugs or drugs can cause secondary osteoporosis (Application of glucocorticoids and androgen, calcitonin, the dose of calcium, phosphate and other two known bone metabolic drug treatment);
3) the function of liver and kidney damage or in patients with a history of pancreatitis;
4) with severe cardiovascular disease, immune system, blood system or endocrine system disease;
5) alcoholics;
6) to test drug allergy or taboo;
7) the use of other drugs and drug interactions.
Age minimum:
18
Age maximum:
70
Gender:
Both
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Health Condition(s) or Problem(s) studied
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T2DM
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Intervention(s)
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saxagliptin group:saxagliptin;Metformin group:Metformin;
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Primary Outcome(s)
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glycosylated hemoglobin;FPG;BGP;tPINP;CRP;
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Source(s) of Monetary Support
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Department research funding
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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