NCT01703637

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable type-2-diabetes-mellitus

Geographic Reach
1 country

8 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

October 6, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 10, 2012

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Last Updated

March 31, 2016

Status Verified

March 1, 2016

Enrollment Period

4.2 years

First QC Date

October 6, 2012

Last Update Submit

March 30, 2016

Conditions

Type 2 Diabetes Mellitus

Keywords

SitagliptinVildagliptinSaxagliptinDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (11)

  • Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12

    Baseline to Week 12

  • Change From Baseline in 2-hour Postprandial Glucose at Week 12

    Baseline and Week 12

  • Change From Baseline in Fasting Insulin at Week 12

    Baseline to Week 12

  • Change From Baseline in Fasting Glucagon at Week 12

    Baseline and Week 12

  • Change From Baseline in 2-hour Postprandial Insulin at Week 12

    Baseline and Week 12

  • +6 more secondary outcomes

Other Outcomes (2)

  • gene polymorphism study

    baseline and week 12

  • change from baseline in content of NOS

    baseline and week 12

Study Arms (3)

Sitagliptin

EXPERIMENTAL

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

Drug: Sitagliptin

Vildagliptin

EXPERIMENTAL

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

Drug: Vildagliptin

Saxagliptin

EXPERIMENTAL

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

Drug: Saxagliptin

Interventions

SitagliptinDRUG

* 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

Also known as: Januvia
Sitagliptin
VildagliptinDRUG

* 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

Also known as: Galvus
Vildagliptin
SaxagliptinDRUG

* 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

Also known as: Onglyza
Saxagliptin

Eligibility Criteria

Age18 Years - 78 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

YuCheng people's hospital

Dezhou, Shandong, 253000, China

RECRUITING

Hospital of SINOTRUK

Jinan, Shandong, 250010, China

RECRUITING

Jinan central hospital

Jinan, Shandong, 250010, China

RECRUITING

The jinan military region general hospital

Jinan, Shandong, 250010, China

RECRUITING

Qianfoshan Hospital

Jinan, Shandong, 250012, China

RECRUITING

People's Hospital of Qingdao Chengyang

Qingdao, Shandong, 266100, China

RECRUITING

Zibo central hospital

Zibo, Shandong, 255000, China

RECRUITING

Zibo eighth people's hospital

Zibo, Shandong, 255000, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 30822272DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sitagliptin PhosphateVildagliptinsaxagliptin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrazinesNitrilesOrganic ChemicalsPyrrolidines

Study Officials

  • Lin Liao, MD

    Qianfoshan Hospital

    STUDY CHAIR

Central Study Contacts

Lin Liao, MD

CONTACT

8615168888260liaolin@medmail.com.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
chief of endocrinology department at Qianfoshan Hospital

Study Record Dates

First Submitted

October 6, 2012

First Posted

October 10, 2012

Study Start

October 1, 2012

Primary Completion

December 1, 2016

Last Updated

March 31, 2016

Record last verified: 2016-03

Locations

CN(8)