Clinical trial NCT01703637: Efficacy and Safety Comparative Study of Sitagliptin,Vildagliptin and Saxagliptin
Official title: A Multicenter, Randomized, Double-Blind Comparative Study of Efficacy，Tolerance and Safety Between Sitagliptin ,Vildagliptin and Saxagliptin After 12-week Monotherapy in Drug-naive Adult Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: Sitagliptin
Vildagliptin
Saxagliptin
Diabetes Mellitus, Type 2
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2012-10-10
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to explore the differences in efficacy and safety of sitagliptin,vildagliptin and saxagliptin and to find which one is more better in treating type 2 diabetes mellitus.


Eligibility criteria: Inclusion Criteria:

* signed the informed consent
* 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:

* patients in pregnancy or lactation period
* 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

Primary outcomes:
measure: Change From Baseline in Hemoglobin A1c (A1C) Levels at Week 12
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12
timeFrame: Baseline to Week 12
measure: Change From Baseline in 2-hour Postprandial Glucose at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Fasting Insulin at Week 12
timeFrame: Baseline to Week 12
measure: Change From Baseline in Fasting Glucagon at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in 2-hour Postprandial Insulin at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in 2-hour Postprandial Glucagon at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in abdominal perimeter at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Body Weight at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Fasting Plasma Lipids at Week 12
timeFrame: Baseline and Week 12
measure: The Proportion of Patients Achieving A1C < 7% and Achieving A1C<6.5% at Week12
timeFrame: Baseline and Week 12
measure: The side effect of each drug.
timeFrame: Baseline to week 12
Other outcomes:
measure: gene polymorphism study
timeFrame: baseline and week 12
measure: change from baseline in content of NOS
timeFrame: baseline and week 12
Locations:
city: Dezhou
country: China
facility: YuCheng people's hospital
state: Shandong
city: Jinan
country: China
facility: Hospital of SINOTRUK
state: Shandong
city: Jinan
country: China
facility: Jinan central hospital
state: Shandong
city: Jinan
country: China
facility: The jinan military region general hospital
state: Shandong
city: Jinan
country: China
facility: Qianfoshan Hospital
state: Shandong
city: Qingdao
country: China
facility: People's Hospital of Qingdao Chengyang
state: Shandong
city: Zibo
country: China
facility: Zibo central hospital
state: Shandong
city: Zibo
country: China
facility: Zibo eighth people's hospital
state: Shandong
Study officials:
affiliation: Qianfoshan Hospital
name: Lin Liao, MD
role: STUDY_CHAIR
References:
citation: 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.