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Efficacy and Safety Comparative Study of Sitagliptin,Vildagliptin and Saxagliptin

Primary Purpose

Type 2 Diabetes Mellitus

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Sitagliptin
Vildagliptin
Saxagliptin
Sponsored by
Lin Liao
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Sitagliptin, Vildagliptin, Saxagliptin, Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - 78 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • YuCheng people's hospitalRecruiting
  • Hospital of SINOTRUKRecruiting
  • Jinan central hospitalRecruiting
  • The jinan military region general hospitalRecruiting
  • Qianfoshan HospitalRecruiting
  • People's Hospital of Qingdao ChengyangRecruiting
  • Zibo central hospitalRecruiting
  • Zibo eighth people's hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Sitagliptin

Vildagliptin

Saxagliptin

Arm Description

Drug: sitagliptin sitagliptin 100mg tablet by mouth , once daily for 12 weeks

Drug: vildagliptin saxagliptin 50mg tablet by mouth , twice daily for 12 weeks

Drug: saxagliptin saxagliptin 5mg tablet by mouth , once daily for 12 weeks

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12
Change From Baseline in 2-hour Postprandial Glucose at Week 12
Change From Baseline in Fasting Insulin at Week 12
Change From Baseline in Fasting Glucagon at Week 12
Change From Baseline in 2-hour Postprandial Insulin at Week 12
Change From Baseline in 2-hour Postprandial Glucagon at Week 12
Change From Baseline in abdominal perimeter at Week 12
Change From Baseline in Body Weight at Week 12
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)
The Proportion of Patients Achieving A1C < 7% and Achieving A1C<6.5% at Week12
The side effect of each drug.

Full Information

First Posted
October 6, 2012
Last Updated
March 30, 2016
Sponsor
Lin Liao
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1. Study Identification

Unique Protocol Identification Number
NCT01703637
Brief Title
Efficacy and Safety Comparative Study of Sitagliptin,Vildagliptin and Saxagliptin
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2012 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lin Liao

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Sitagliptin, Vildagliptin, Saxagliptin, Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sitagliptin
Arm Type
Experimental
Arm Description
Drug: sitagliptin sitagliptin 100mg tablet by mouth , once daily for 12 weeks
Arm Title
Vildagliptin
Arm Type
Experimental
Arm Description
Drug: vildagliptin saxagliptin 50mg tablet by mouth , twice daily for 12 weeks
Arm Title
Saxagliptin
Arm Type
Experimental
Arm Description
Drug: saxagliptin saxagliptin 5mg tablet by mouth , once daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Sitagliptin
Other Intervention Name(s)
Januvia
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Vildagliptin
Other Intervention Name(s)
Galvus
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Saxagliptin
Other Intervention Name(s)
Onglyza
Intervention Description
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
Primary Outcome Measure Information:
Title
Change From Baseline in Hemoglobin A1c (A1C) Levels at Week 12
Description
Change from baseline reflects the Week 12 value minus the baseline value. A1C represents the percentage of glycosylated hemoglobin
Time Frame
Baseline and Week 12
Secondary Outcome Measure Information:
Title
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12
Time Frame
Baseline to Week 12
Title
Change From Baseline in 2-hour Postprandial Glucose at Week 12
Time Frame
Baseline and Week 12
Title
Change From Baseline in Fasting Insulin at Week 12
Time Frame
Baseline to Week 12
Title
Change From Baseline in Fasting Glucagon at Week 12
Time Frame
Baseline and Week 12
Title
Change From Baseline in 2-hour Postprandial Insulin at Week 12
Time Frame
Baseline and Week 12
Title
Change From Baseline in 2-hour Postprandial Glucagon at Week 12
Time Frame
Baseline and Week 12
Title
Change From Baseline in abdominal perimeter at Week 12
Time Frame
Baseline and Week 12
Title
Change From Baseline in Body Weight at Week 12
Time Frame
Baseline and Week 12
Title
Change From Baseline in Fasting Plasma Lipids at Week 12
Description
fasting plasma lipid parameters including total cholesterol(TC), triglyceride(TG) and Low density lipoprotein(LDL)
Time Frame
Baseline and Week 12
Title
The Proportion of Patients Achieving A1C < 7% and Achieving A1C<6.5% at Week12
Time Frame
Baseline and Week 12
Title
The side effect of each drug.
Time Frame
Baseline to week 12
Other Pre-specified Outcome Measures:
Title
gene polymorphism study
Description
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.
Time Frame
baseline and week 12
Title
change from baseline in content of NOS
Time Frame
baseline and week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
78 Years
Accepts Healthy Volunteers
No
Eligibility 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lin Liao, MD
Phone
8615168888260
Email
liaolin@medmail.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lin Liao, MD
Organizational Affiliation
Qianfoshan Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
YuCheng people's hospital
City
Dezhou
State/Province
Shandong
ZIP/Postal Code
253000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pengfei Li
Email
lpf9669@163.com
Facility Name
Hospital of SINOTRUK
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250010
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiling Fu
Email
fxl1936@163.com
Facility Name
Jinan central hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250010
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shuguang Pang
Email
shuguangpang@163.com
Facility Name
The jinan military region general hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250010
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhaoshun Jiang
Email
zhaoshunjiang@sohu.com
Facility Name
Qianfoshan Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lin Liao, MD
Phone
8615168888260
Email
liaolin@medmail.com.cn
Facility Name
People's Hospital of Qingdao Chengyang
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266100
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaopang Rao
Email
123raoxiaopang@163.com
Facility Name
Zibo central hospital
City
Zibo
State/Province
Shandong
ZIP/Postal Code
255000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaodong Zhao
Email
19xiaodong@163.com
Facility Name
Zibo eighth people's hospital
City
Zibo
State/Province
Shandong
ZIP/Postal Code
255000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ling Dai
Phone
+86 13853388549

12. IPD Sharing Statement

Citations:
PubMed Identifier
30822272
Citation
Zhou XJ, Ding L, Liu JX, Su LQ, Dong JJ, Liao L. Efficacy and short-term side effects of sitagliptin, vildagliptin and saxagliptin in Chinese diabetes: a randomized clinical trial. Endocr Connect. 2019 Apr;8(4):318-325. doi: 10.1530/EC-18-0523.
Results Reference
derived

Learn more about this trial

Efficacy and Safety Comparative Study of Sitagliptin,Vildagliptin and Saxagliptin

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