Type 2 Diabetes Mellitus
Conditions
Keywords
Sitagliptin, Vildagliptin, Saxagliptin, Diabetes Mellitus, Type 2
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.
Interventions
DRUGSitagliptin
* 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
DRUGVildagliptin
* 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
DRUGSaxagliptin
* 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
Sponsors
Lin Liao
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 78 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Hemoglobin A1c (A1C) Levels at Week 12 | Baseline and Week 12 | Change from baseline reflects the Week 12 value minus the baseline value. A1C represents the percentage of glycosylated hemoglobin |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 | — |
| 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 | Baseline and Week 12 | fasting plasma lipid parameters including total cholesterol(TC), triglyceride(TG) and Low density lipoprotein(LDL) |
Other
| Measure | Time frame | Description |
|---|---|---|
| gene polymorphism study | baseline and week 12 | 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. |
| change from baseline in content of NOS | baseline and week 12 | — |
Countries
China
Contacts
Primary ContactLin Liao, MD
Outcome results
None listed