| Trial ID: | L5976 |
| Source ID: | NCT02617732
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| Associated Drug: |
Tianqi Capsule
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| Title: |
Effects of Tianqi Capsule on Glucose Variability in Patients With Type 2 Diabetes.
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
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| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Tianqi capsule|DRUG: placebo
|
| Outcome Measures: |
Primary: Change from baseline in mean amplitude of glycemic excursions (MAGE) and mean of daily differences (MODD) at 12 weeks., Glucose variability is evaluated by continuous glucose monitoring system, the main parameters include mean amplitude of glycemic excursions (MAGE)(mmol/L) and mean of daily differences (MODD)(mmol/L). The amplitude of glycemic excursions（AGE）is obtained by continuous glucose, MAGE is calculated using the criterion that both segments of the amplitude of glycemic excursions (AGE) exceed 1 SD, the calculations were carried out as described below, using the formula: MAGE (mg/dL)=∑AGE/n (n=number of glycemic excursions\>1 SD). The MODD was calculated as the mean of the absolute difference of glucose values from corresponding times of day from two consecutive days., 12 weeks | Secondary: Change from baseline in serum lipid and lipoprotein at 12 weeks., Serum lipid and lipoprotein including: triglyceride (TC) (mmol/L); total cholesterol (TG) (mmol/L); low density lipoprotein cholesterol (LDL-C) (mmol/L); high density lipoprotein cholesterol (HDL-C) (mmol/L), 12 weeks|Change from baseline in hemoglobin A1c(HbA1c) at 12 weeks, 12 weeks|Liver Function Examination, Liver function examination including alanine aminotransferase (ALT) (U/L) and aspartate transaminase (AST) (U/L)., 4 weeks|Renal Function Examination, Renal function examination including blood urea nitrogen(BUN)（mmol/L）and urine creatinine(UCr) (mmol/d)., 4 weeks
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| Sponsor/Collaborators: |
Sponsor: Peking Union Medical College Hospital
|
| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
100
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: TREATMENT
|
| Start Date: |
2016-01
|
| Completion Date: |
2018-02
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| Results First Posted: |
|
| Last Update Posted: |
2015-12-01
|
| Locations: |
Peking Union Medical College Hospital traditional Chinese medicine department, Beijing, Beijing, 100730, China
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| URL: |
https://clinicaltrials.gov/show/NCT02617732
|
