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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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ClinicalTrials.gov |
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Last refreshed on:
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7 December 2015 |
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Main ID: |
NCT02605772 |
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Date of registration:
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12/11/2015 |
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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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Safety and Efficacy of Acarbose+Saxagliptin Compared With Metformin+Saxagliptin in Patients With Type 2 Diabetes
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Scientific title:
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A Randomized, Non-inferiority, Open-label Clinical Trial to Evaluate the Safety and Efficacy of GAcarbose+Saxagliptin Compared With Metformin+Saxagliptin in Patients With Type 2 Diabetes in Chinese |
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Date of first enrolment:
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December 2015 |
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Target sample size:
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100 |
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Recruitment status: |
Not yet recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02605772 |
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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: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Newly diagnosed type 2 diabetes mellitus(course of disease less than one year) who
has not receive drug treatment.
- T2DM patients who has not receive drug treatment for three months at least.
- HbA1c for 7.5-10%.
Exclusion Criteria:
- New or worsening signs or symptoms of coronary heart disease
- Medical history of active liver disease and kidney disease
- Poorly controlled hypertension(systolic blood pressure>160mmHg or diastolic blood
pressure>95mmHg)
- A clinically important hematological disorder
- A history of intolerance or hypersensitivity or any contraindication to study
medications (including saxagliptin, metformin, acarbose)
- Is pregnant or breast feeding or is expecting to conceive or donate eggs
- A medical history of drug abuse
- Can not be followed -up on time
- Endocrinological diseases(eg: hyperthyroidism?hypothyroidisn and cushing syndrom)
- Gastrointestinal diseases
- Mental disorser
- Hypoxic disease
Age minimum:
20 Years
Age maximum:
75 Years
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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Drug: Acarbose
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Drug: Saxagliptin
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Drug: Metformin
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Primary Outcome(s)
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redunction of Hemoglobin A1c (HbA1c) Levels (%) in two groups respectively after three months intervention
[Time Frame: baseline(0 week), week twelve]
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Secondary Outcome(s)
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Proportion of patients who achieve target of HbA1c<6.5% in two groups respectively at the end of study
[Time Frame: baseline(0 week), week twelve]
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Difference of Homeostasis model assessment of insulin resistance (HOMA-IR) and Homeostasis model assessment beta cell function index (HOMA-ß) between two groups after three months intervention
[Time Frame: baseline(0 week), week twelve]
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Secondary ID(s)
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FifthSunYetSen
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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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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