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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-TRC-13003858 |
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Date of registration:
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2013-10-10 |
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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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The study of Dipeptidyl peptidase-IV inhibitor's efficacy and safety when it is applied on type 2 diabetes whose blood suger was poorly controlled with original oral antidiabetic drug
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Scientific title:
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The study of Dipeptidyl peptidase-IV inhibitor's efficacy and safety when it is applied on type 2 diabetes whose blood suger was poorly controlled with original oral antidiabetic drug |
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Date of first enrolment:
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2013-11-01 |
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Target sample size:
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2 groups:40; |
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Recruitment status: |
Completed |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=5707 |
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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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IV (Phase IV study)
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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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Jing Wang
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Address:
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151 West Yanjiang Road, Guangzhou, China
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Telephone:
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+86 15920423850 |
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Email:
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1045780384@qq.com |
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Affiliation:
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The First Hospital, Guangzhou Medical University |
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Name:
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Tan YuYu
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Address:
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151 West Yanjiang Road, Guangzhou, China
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Telephone:
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+86 020-83062305 |
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Email:
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yy_tan@163.com |
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Affiliation:
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The First Hospital, Guangzhou Medical University |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Signed informed consent;
2. Aged 18 to 70 years type 2 diabetic patients, the original therapy in stable for more than 2 months, poor blood sugar control;
3. visit 1, body mass index (BMI) in 18.5-40 kg/m2 (including 18.5-40 kg/m2).
Exclusion criteria: 1. In patients with type 1.1 diabetes, or secondary diabetes mellitus;
2. pregnancy or breast-feeding women (Mi Ru);
3. diabetic emergencies such as: acute infection, stress, peri operation period, the use of corticosteroids, acute heart, brain, kidney failure state;
4. diabetic ketoacidosis or hyperosmolar nonketotic coma history;
5. The researchers think that patients can not be any situation successfully completed research;
6. plus other antidiabetic drugs, serious adverse drug reaction, are unwilling to continue the medication and the respondent.
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 mellitus
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Intervention(s)
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2 groups: saxagliptin vs Vildagliptin;
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Primary Outcome(s)
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glycosylated hemoglobin;
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Source(s) of Monetary Support
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Pharmaceutical Association
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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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