Efficacy and Safety Comparative Study of Sitagliptin,Vildagliptin and Saxagliptin

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Qianfoshan Hospital
Sponsor:
Information provided by (Responsible Party):
Lin Liao, Qianfoshan Hospital
ClinicalTrials.gov Identifier:
NCT01703637
First received: October 6, 2012
Last updated: November 7, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Type 2 Diabetes Mellitus
Drug: Sitagliptin
Drug: Vildagliptin
Drug: Saxagliptin

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

Resource links provided by NLM:


Further study details as provided by Qianfoshan Hospital:

Primary Outcome Measures:
  • Change From Baseline in Hemoglobin A1c (A1C) Levels at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    Change from baseline reflects the Week 12 value minus the baseline value. A1C represents the percentage of glycosylated hemoglobin


Secondary Outcome Measures:
  • Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12 [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
  • Change From Baseline in 2-hour Postprandial Glucose at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
  • Change From Baseline in Fasting Insulin at Week 12 [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
  • Change From Baseline in Fasting Glucagon at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
  • Change From Baseline in 2-hour Postprandial Insulin at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
  • Change From Baseline in 2-hour Postprandial Glucagon at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
  • Change From Baseline in 2-hour Postprandial Glucagon-like Peptide-1 (GLP-1) at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
  • Change From Baseline in Body Weight at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
  • Change From Baseline in Fasting Plasma Lipids at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    fasting plasma lipid parameters including total cholesterol(TC), triglyceride(TG) and Low density lipoprotein(LDL)

  • The Proportion of Patients Achieving A1C < 7% and Achieving A1C<6.5% at Week12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • gene polymorphism study [ Time Frame: baseline and week 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline and week 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: October 2012
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sitagliptin
Drug: sitagliptin sitagliptin 100mg tablet by mouth , once daily for 12 weeks
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
Other Name: Januvia
Experimental: Vildagliptin
Drug: vildagliptin saxagliptin 50mg tablet by mouth , twice daily for 12 weeks
Drug: 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
Other Name: Galvus
Experimental: Saxagliptin
Drug: saxagliptin saxagliptin 5mg tablet by mouth , once daily for 12 weeks
Drug: 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 Name: Onglyza

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 7.0-9.0%

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01703637

Contacts
Contact: Lin Liao, MD 8615168888260 liaolin@medmail.com.cn

Locations
China, Shandong
YuCheng people's hospital Recruiting
Dezhou, Shandong, China, 253000
Contact: Pengfei Li       lpf9669@163.com   
Qianfoshan Hospital Recruiting
Jinan, Shandong, China, 250012
Contact: Lin Liao, MD    8615168888260    liaolin@medmail.com.cn   
The jinan military region general hospital Recruiting
Jinan, Shandong, China, 250010
Contact: Zhaoshun Jiang       zhaoshunjiang@sohu.com   
Jinan central hospital Recruiting
Jinan, Shandong, China, 250010
Contact: Shuguang Pang       shuguangpang@163.com   
Hospital of SINOTRUK Recruiting
Jinan, Shandong, China, 250010
Contact: Xiling Fu       fxl1936@163.com   
People's Hospital of Qingdao Chengyang Recruiting
Qingdao, Shandong, China, 266100
Contact: Xiaopang Rao       123raoxiaopang@163.com   
Zibo eighth people's hospital Recruiting
Zibo, Shandong, China, 255000
Contact: Ling Dai    +86 13853388549      
Zibo central hospital Recruiting
Zibo, Shandong, China, 255000
Contact: Xiaodong Zhao       19xiaodong@163.com   
Sponsors and Collaborators
Lin Liao
Investigators
Study Chair: Lin Liao, MD Qianfoshan Hospital
  More Information

No publications provided

Responsible Party: Lin Liao, chief of endocrinology department at Qianfoshan Hospital, Qianfoshan Hospital
ClinicalTrials.gov Identifier: NCT01703637     History of Changes
Other Study ID Numbers: qfsnfm-001
Study First Received: October 6, 2012
Last Updated: November 7, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Qianfoshan Hospital:
Sitagliptin
Vildagliptin
Saxagliptin
Diabetes Mellitus, Type 2

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin
Vildagliptin
Saxagliptin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014