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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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18 April 2017 |
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Main ID: |
ChiCTR-IPR-17010329 |
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Date of registration:
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2017-01-04 |
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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 on bone metabolism in type 2 diabetic
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Scientific title:
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Effect of saxagliptin on bone metabolism in type 2 diabetic |
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Date of first enrolment:
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2017-01-09 |
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Target sample size:
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A:40;B:40; |
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Recruitment status: |
Recruiting |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=12662 |
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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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Post-market
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Countries of recruitment
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China
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Contacts
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Name:
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Xiaomei Liu
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Address:
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68 Changle Road, Qinhuai District, Nanjing, Jiangsu, China
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Telephone:
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+86 15366110069 |
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Email:
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lxmxjtu@sina.com |
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Affiliation:
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Nanjing First Hospital, Nanjing Medical University |
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Name:
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Xiaomei Liu
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Address:
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68 Changle Road, Qinhuai District, Nanjing, Jiangsu, China
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Telephone:
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+86 15366110069 |
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Email:
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lxmxjtu@sina.com |
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Affiliation:
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Nanjing First Hospital, Nanjing Medical University |
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Key inclusion & exclusion criteria
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Inclusion criteria: Type 2 diabetes (HbA1c 7.5% to 11.0%, FPG <270mg/dL), equal or more than 18 years old, with the baseline treatment more than 8 weeks (insulin alone or combination therapy of insulin and metformin, the total daily dose of insulin is more than 20 and less than 150 units).
Exclusion criteria: 1. Patiens accepted other drugs during the past 3 month;
2. A history of drug abuse alcohol dependence in the past 5 years;
3. using the intravenous hormone therapy;
4. Pregnancy, breast-feeding,or not using enough contraception(enough refers to the intrauterine device, oral contraceptives, prevent measures);
5. Poor adherence;
6. The probabl basic diseases which may obstruct this study,such as active malignancy, cardiomyopathy, mental disease;
7. There is infection during the past 4 weeks.
Age minimum:
18
Age maximum:
70
Gender:
Both
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Health Condition(s) or Problem(s) studied
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type 2 diabetes
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Intervention(s)
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A:Saxagliptin;B:placebo;
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Secondary Outcome(s)
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OCN;ALP;Ca;P;PTH;
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Source(s) of Monetary Support
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Major Project of Technological Development of Nanjing Medical University
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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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