Efficacy and Safety Comparative Study of Sitagliptin,Vildagliptin and Saxagliptin
NCT ID: NCT01703637
Last Updated: 2016-03-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
300 participants
INTERVENTIONAL
2012-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Sitagliptin
Drug: sitagliptin sitagliptin 100mg tablet by mouth , once daily for 12 weeks
Sitagliptin
* before breakfast：a tablet of sitagliptin; a tablet of vildagliptin's dummy; a tablet of saxagliptin's dummy
* before dinner：a tablet of sitagliptin's dummy; a tablet of vildagliptin's dummy; a tablet of saxagliptin's dummy
Vildagliptin
Drug: vildagliptin saxagliptin 50mg tablet by mouth , twice daily for 12 weeks
Vildagliptin
* before breakfast：a tablet of vildagliptin; a tablet of sitagliptin's dummy; a tablet of saxagliptin's dummy
* before dinner：a tablet of vildagliptin; a tablet of sitagliptin's dummy; a tablet of saxagliptin's dummy
Saxagliptin
Drug: saxagliptin saxagliptin 5mg tablet by mouth , once daily for 12 weeks
Saxagliptin
* before breakfast：a tablet of saxagliptin; a tablet of vildagliptin's dummy; a tablet of sitagliptin's dummy
* before dinner：a tablet of saxagliptin's dummy; a tablet of vildagliptin's dummy; a tablet of sitagliptin's dummy
Interventions
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Sitagliptin
* before breakfast：a tablet of sitagliptin; a tablet of vildagliptin's dummy; a tablet of saxagliptin's dummy
* before dinner：a tablet of sitagliptin's dummy; a tablet of vildagliptin's dummy; a tablet of saxagliptin's dummy
Vildagliptin
* before breakfast：a tablet of vildagliptin; a tablet of sitagliptin's dummy; a tablet of saxagliptin's dummy
* before dinner：a tablet of vildagliptin; a tablet of sitagliptin's dummy; a tablet of saxagliptin's dummy
Saxagliptin
* before breakfast：a tablet of saxagliptin; a tablet of vildagliptin's dummy; a tablet of sitagliptin's dummy
* before dinner：a tablet of saxagliptin's dummy; a tablet of vildagliptin's dummy; a tablet of sitagliptin's dummy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* diagnosed with T2DM
* women of childbearing potential were required to have a negative urine; pregnancy test,and agreed to use adequate contraception throughout the; study and for up to 4 weeks after completion
* glycosylated hemoglobin ranged in 6.5-9.5%
Exclusion Criteria
* ever received any kind of oral Hypoglycemic drug in recent 3 months
* patients were currently receiving treatment with a cytochrome P450 3A4 inducer or depressor,a systemic corticosteroid,or a human immunodeficiency virus anti-viral medication
* gastrointestinal surgery that could affect drug absorption
* patients with haemoglobinopathy or rapidly progressing renal disease, or autoimmune skin disorder
* a recent history of alcohol or drug abuse within the past 12 months
* any contraindication listed in the package inserts of the study drugs
* a history of acute or chronic Pancreatitis or currently
* type 1 diabetes; a history of diabetic ketoacidosis or hyperosmolar nonketonic coma
* New York Heart Association class III or IV congestive heart failure; left ventricular ejection fraction ≤ 40%; a major cardiovascular event within the past 6 months
* significant abnormal liver function, defined as aspartate aminotransferase or alanine aminotransferase \> 2 times the upper limit of normal or total bilirubin \>34 µmol/L (\> 2 mg/dL); or a history of positive serologic evidence of infectious liver disease
* clinical signs or symptoms of active liver disease and/or significant abnormal liver function
* patients with any clinically significant abnormality identified on physical examination, electrocardiogram (ECG), or laboratory tests that, in the judgment of the investigator, would compromise the patients' safety or successful participation in the clinical study
* fasting plasma glucose level \> 13.3mmol/l
* creatinine clearance rate ≤ 90ml/min
18 Years
78 Years
ALL
No
Sponsors
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Lin Liao
OTHER
Responsible Party
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Lin Liao
chief of endocrinology department at Qianfoshan Hospital
Principal Investigators
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Lin Liao, MD
Role: STUDY_CHAIR
Qianfoshan Hospital
Locations
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YuCheng people's hospital
Dezhou, Shandong, China
Hospital of SINOTRUK
Jinan, Shandong, China
Jinan central hospital
Jinan, Shandong, China
The jinan military region general hospital
Jinan, Shandong, China
Qianfoshan Hospital
Jinan, Shandong, China
People's Hospital of Qingdao Chengyang
Qingdao, Shandong, China
Zibo central hospital
Zibo, Shandong, China
Zibo eighth people's hospital
Zibo, Shandong, China
Countries
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Central Contacts
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Facility Contacts
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Ling Dai
Role: primary
References
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Zhou XJ, Ding L, Liu JX, Su LQ, Dong JJ, Liao L. Efficacy and short-term side effects of sitagliptin, vildagliptin and saxagliptin in Chinese diabetes: a randomized clinical trial. Endocr Connect. 2019 Apr;8(4):318-325. doi: 10.1530/EC-18-0523.
Other Identifiers
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qfsnfm-001
Identifier Type: -
Identifier Source: org_study_id
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