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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lin Liao

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2012

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 6, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 10, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 31, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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