| Trial ID: | L5757 |
| Source ID: | NCT01703637
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| Associated Drug: |
Sitagliptin
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| Title: |
Efficacy and Safety Comparative Study of Sitagliptin,Vildagliptin and Saxagliptin
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| Acronym: |
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| Status: |
UNKNOWN
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| Study Results: |
NO
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| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
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| Interventions: |
DRUG: Sitagliptin|DRUG: Vildagliptin|DRUG: Saxagliptin
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| Outcome Measures: |
Primary: Change From Baseline in Hemoglobin A1c (A1C) Levels at Week 12, Change from baseline reflects the Week 12 value minus the baseline value. A1C represents the percentage of glycosylated hemoglobin, Baseline and Week 12 | Secondary: Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12, Baseline to Week 12|Change From Baseline in 2-hour Postprandial Glucose at Week 12, Baseline and Week 12|Change From Baseline in Fasting Insulin at Week 12, Baseline to Week 12|Change From Baseline in Fasting Glucagon at Week 12, Baseline and Week 12|Change From Baseline in 2-hour Postprandial Insulin at Week 12, Baseline and Week 12|Change From Baseline in 2-hour Postprandial Glucagon at Week 12, Baseline and Week 12|Change From Baseline in abdominal perimeter at Week 12, Baseline and Week 12|Change From Baseline in Body Weight at Week 12, Baseline and Week 12|Change From Baseline in Fasting Plasma Lipids at Week 12, fasting plasma lipid parameters including total cholesterol(TC), triglyceride(TG) and Low density lipoprotein(LDL), Baseline and Week 12|The Proportion of Patients Achieving A1C < 7% and Achieving A1C<6.5% at Week12, Baseline and Week 12|The side effect of each drug., Baseline to week 12 | Other: gene polymorphism study, We will choose 6 mutation types of CYP3A4 common in Chinese,and make blood medicinal concentration assay of participants with these gene types,and then analyse the association between different gene types and the change of glucose level or HbA1c or rate of adverse event., baseline and week 12|change from baseline in content of NOS, baseline and week 12
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| Sponsor/Collaborators: |
Sponsor: Lin Liao
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
|
| Enrollment: |
300
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
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| Start Date: |
2012-10
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| Completion Date: |
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| Results First Posted: |
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| Last Update Posted: |
2016-03-31
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| Locations: |
YuCheng people's hospital, Dezhou, Shandong, 253000, China|Hospital of SINOTRUK, Jinan, Shandong, 250010, China|Jinan central hospital, Jinan, Shandong, 250010, China|The jinan military region general hospital, Jinan, Shandong, 250010, China|Qianfoshan Hospital, Jinan, Shandong, 250012, China|People's Hospital of Qingdao Chengyang, Qingdao, Shandong, 266100, China|Zibo central hospital, Zibo, Shandong, 255000, China|Zibo eighth people's hospital, Zibo, Shandong, 255000, China
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| URL: |
https://clinicaltrials.gov/show/NCT01703637
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