Efficacy and Safety Comparative Study of Sitagliptin,Vildagliptin and Saxagliptin

March 30, 2016 updated by: Lin Liao

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Dezhou, Shandong, China, 253000
        • Recruiting
        • YuCheng people's hospital
        • Contact:
      • Jinan, Shandong, China, 250010
        • Recruiting
        • Hospital of SINOTRUK
        • Contact:
      • Jinan, Shandong, China, 250010
      • Jinan, Shandong, China, 250010
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Qianfoshan Hospital
        • Contact:
      • Qingdao, Shandong, China, 266100
      • Zibo, Shandong, China, 255000
      • Zibo, Shandong, China, 255000
        • Recruiting
        • Zibo eighth people's hospital
        • Contact:
          • Ling Dai
          • Phone Number: +86 13853388549

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • 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 Names:
  • Onglyza

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Hemoglobin A1c (A1C) Levels at Week 12
Time Frame: Baseline and 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
Time Frame: Baseline to Week 12
Baseline to Week 12
Change From Baseline in 2-hour Postprandial Glucose at Week 12
Time Frame: Baseline and Week 12
Baseline and Week 12
Change From Baseline in Fasting Insulin at Week 12
Time Frame: Baseline to Week 12
Baseline to Week 12
Change From Baseline in Fasting Glucagon at Week 12
Time Frame: Baseline and Week 12
Baseline and Week 12
Change From Baseline in 2-hour Postprandial Insulin at Week 12
Time Frame: Baseline and Week 12
Baseline and Week 12
Change From Baseline in 2-hour Postprandial Glucagon at Week 12
Time Frame: Baseline and Week 12
Baseline and Week 12
Change From Baseline in abdominal perimeter at Week 12
Time Frame: Baseline and Week 12
Baseline and Week 12
Change From Baseline in Body Weight at Week 12
Time Frame: Baseline and Week 12
Baseline and Week 12
Change From Baseline in Fasting Plasma Lipids at Week 12
Time Frame: Baseline and 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
Time Frame: Baseline and Week 12
Baseline and Week 12
The side effect of each drug.
Time Frame: Baseline to week 12
Baseline to week 12

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
gene polymorphism study
Time Frame: 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.
baseline and week 12
change from baseline in content of NOS
Time Frame: baseline and week 12
baseline and week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lin Liao

Investigators

  • Study Chair: Lin Liao, MD, Qianfoshan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

October 6, 2012

First Submitted That Met QC Criteria

October 9, 2012

First Posted (Estimate)

October 10, 2012

Study Record Updates

Last Update Posted (Estimate)

March 31, 2016

Last Update Submitted That Met QC Criteria

March 30, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • qfsnfm-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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