Efficacy and Safety Comparative Study of Sitagliptin,Vildagliptin and Saxagliptin

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Sitagliptin
* Drug: Vildagliptin
* Drug: Saxagliptin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 78 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sitagliptin<br>Drug: sitagliptin sitagliptin 100mg tablet by mouth , once daily for 12 weeks | Drug: Sitagliptin<br>* 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<br>* Other names: Januvia;|
| Experimental: Vildagliptin<br>Drug: vildagliptin saxagliptin 50mg tablet by mouth , twice daily for 12 weeks | Drug: Vildagliptin<br>* 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<br>* Other names: Galvus;|
| Experimental: Saxagliptin<br>Drug: saxagliptin saxagliptin 5mg tablet by mouth , once daily for 12 weeks | Drug: Saxagliptin<br>* 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<br>* Other names: Onglyza;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sitagliptin, Vildagliptin, Saxagliptin, Diabetes Mellitus, Type 2