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Main
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Note: This record shows only the 20 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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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00544518 |
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Date of registration:
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15/10/2007 |
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Primary sponsor: |
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Public title:
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Impact of Benfluorex Versus Metformin on Glucose Control and Insulin Secretion in Chinese Type 2 Diabetic Patients
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Scientific title:
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Date of first enrolment:
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October 2007 |
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Target sample size:
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240 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00544518 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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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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Ji qiuhe, Ph.D |
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Address:
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Telephone:
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Email:
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Affiliation:
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Fourth Military Medical University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- For inclusion in the study, participants will be;? Antidiabetic drugs naïve Type 2
diabetes mellitus(WHO standard) with diet control more than 2 weeks; ?or diagnosed
Type 2 diabetes mellitus with no oral antidiabetic drugs more than 6months; ?or Type
2 diabetes mellitus treated with insulin secretagogues more than 1 month; all
patients have HbA1c between 7.0-10.0% and fasting glucose between
7.0mmol/L~13.0mmol/L.
- Ages Eligible for Study: 18 Years --70 Years, Genders:Both
- BMI: 23~40kg/m2
- No using insulin before 3 months
- Consent to do birth control to Women of child-bearing age
- Volunteer to join and sign Information consent form
Exclusion Criteria:
- Patients with ketoacidosis?hyperglycemic hyperosmolar syndrome.
- Patients with severe diabetic complications
- Patient with acute cardiovascular diseases,acute cerebrovascular diseases,with
Vitamin B12?folic acid and iron deficiency,with severe trauma or surgery,severe
infection diseases.
- Allergy to benfluorex or metformin
- ALT?AST> 2 times of upper normal limit,Cr> upper normal limit.
- Having used benfluorex within 3 months before recruiting.
- Patients accepting steroid hormones or malignant tumor treatment
- Patients with drug abuse or bibulous history.
- Patients with severe unconscious low blood glucose history,severe mental illness
history and family history
- Severe hypertensive patients(SBP>160 mmHg,DBP>95mmHg)
- Patient with pancreas diseases.
Age minimum:
18 Years
Age maximum:
70 Years
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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Drug: benfluorex
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Drug: metformin
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Primary Outcome(s)
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The change of HbA1c from baseline to the end of treatment
[Time Frame: 16 weeks]
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Secondary Outcome(s)
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the changes of fasting and after standard meal glucose and insulin level and plasma lipid level
[Time Frame: 16 weeks]
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Secondary ID(s)
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bfls071012
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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