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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-17010318 |
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Date of registration:
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2017-01-04 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The influence of saxagliptin as add-on therapy to premixed insulin on the glucolipid metabolism in elderly, insulin-requiring patients with type 2 diabetes mellitus.
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Scientific title:
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The influence of saxagliptin as add-on therapy to premixed insulin on the glucolipid metabolism in elderly, insulin-requiring patients with type 2 diabetes mellitus. |
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Date of first enrolment:
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2017-01-01 |
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Target sample size:
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observation group:30;control 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=17490 |
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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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Xu Yan
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Address:
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108 Xiaotun Road, Fengtai District, Beijing
100166
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Telephone:
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+86 18811089567 |
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Email:
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xuyan9250@163.com |
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Affiliation:
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Peking University Shougang Hospital |
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Name:
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Xu Yan
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Address:
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108 Xiaotun Road, Fengtai District, Beijing
100166
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Telephone:
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+86 18811089567 |
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Email:
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xuyan9250@163.com |
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Affiliation:
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Peking University Shougang Hospital |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Age greater than or equal to 65 years;
2. Always have lifestyle intervention and has been the use of premixed insulin 30 r more than 12 weeks, but a poor blood sugar control;
3. HbA1c:between 6.5% and 10.0%;
4. Good compliance.
Exclusion criteria: T1DM; Pregnancy or lactation plan the next six months pregnant women;anemia; Patients with cardiocerebrovascular events; Patients with ketosis;cancer; Stress/infection;Patients with anorexia nervosa and gastrointestinal short circuit operation; Severe heart liver kidney and gastrointestinal disorders; Research before the administration of drugs affect carbohydrate steady-state.
Age minimum:
65
Age maximum:
85
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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observation group:saxagliptin plus to insulin;control group:insulin;
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Primary Outcome(s)
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pancreatic function;lipids;body fat percentage;
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Secondary Outcome(s)
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inflammatory marks;body weight;
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Source(s) of Monetary Support
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scientific research fund of Peking University Shougang Hospital in 2016
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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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