Efficacy and Safety Comparative Study of Sitagliptin,Vildagliptin and Saxagliptin

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01703637
• Other study ID #: qfsnfm-001
• Status: Recruiting
• Phase: N/A
• First received: October 6, 2012
• Last updated: March 30, 2016
• Start date: October 2012

Study information

• Verified date: March 2016
• Source: Qianfoshan Hospital
• Contact: Lin Liao, MD
• Phone: 8615168888260
• Email: liaolin[@]medmail.com.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 78 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• 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

Locations

Country	Name	City	State
China	YuCheng people's hospital	Dezhou	Shandong
China	Hospital of SINOTRUK	Jinan	Shandong
China	Jinan central hospital	Jinan	Shandong
China	Qianfoshan Hospital	Jinan	Shandong
China	The jinan military region general 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

Sponsors (1)

Lead Sponsor	Collaborator
Lin Liao

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	No
Other	change from baseline in content of NOS		baseline and week 12	No
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	No
Secondary	Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12		Baseline to Week 12	No
Secondary	Change From Baseline in 2-hour Postprandial Glucose at Week 12		Baseline and Week 12	No
Secondary	Change From Baseline in Fasting Insulin at Week 12		Baseline to Week 12	No
Secondary	Change From Baseline in Fasting Glucagon at Week 12		Baseline and Week 12	No
Secondary	Change From Baseline in 2-hour Postprandial Insulin at Week 12		Baseline and Week 12	No
Secondary	Change From Baseline in 2-hour Postprandial Glucagon at Week 12		Baseline and Week 12	No
Secondary	Change From Baseline in abdominal perimeter at Week 12		Baseline and Week 12	No
Secondary	Change From Baseline in Body Weight at Week 12		Baseline and Week 12	No
Secondary	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	No
Secondary	The Proportion of Patients Achieving A1C < 7% and Achieving A1C<6.5% at Week12		Baseline and Week 12	No
Secondary	The side effect of each drug.		Baseline to week 12	No