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Status unknownNCT01703637Updated Mar 31, 2016

Efficacy and Safety Comparative Study of Sitagliptin,Vildagliptin and Saxagliptin

An interventional study of Sitagliptin and Vildagliptin in Type 2 Diabetes Mellitus, sponsored by Lin Liao. Status unknown at 8 sites in China. Open to participants aged 18 Years to 78 Years. Per ClinicalTrials.gov, last updated 2016-03-31.

Sponsored by Lin Liao · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years to 78 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Type 2 Diabetes Mellitus

Keywords

  • Sitagliptin
  • Vildagliptin
  • Saxagliptin
  • Diabetes Mellitus, Type 2
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's planned enrollment of 300 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Lin Liao is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 78 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
300 participants (estimated)

Study arms

  • Experimental
    Sitagliptin

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

    Drug: Sitagliptin

  • Experimental
    Vildagliptin

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

    Drug: Vildagliptin

  • Experimental
    Saxagliptin

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

    Drug: Saxagliptin

Interventions

  • DrugSitagliptin

    * 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

  • DrugVildagliptin

    * 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

  • DrugSaxagliptin

    * 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

06

What researchers measure

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

    Time frame: Baseline and Week 12

Secondary outcomes

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

    Time frame: Baseline to Week 12

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

    Time frame: Baseline and Week 12

  3. Change From Baseline in Fasting Insulin at Week 12

    Time frame: Baseline to Week 12

  4. Change From Baseline in Fasting Glucagon at Week 12

    Time frame: Baseline and Week 12

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

    Time frame: Baseline and Week 12

  6. Change From Baseline in 2-hour Postprandial Glucagon at Week 12

    Time frame: Baseline and Week 12

  7. Change From Baseline in abdominal perimeter at Week 12

    Time frame: Baseline and Week 12

  8. Change From Baseline in Body Weight at Week 12

    Time frame: Baseline and Week 12

  9. 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)

    Time frame: Baseline and Week 12

  10. The Proportion of Patients Achieving A1C < 7% and Achieving A1C<6.5% at Week12

    Time frame: Baseline and Week 12

  11. The side effect of each drug.

    Time frame: Baseline to week 12

Other outcomes

  1. gene polymorphism study

    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

  2. change from baseline in content of NOS

    Time frame: baseline and week 12

07

Study locations

8 of 8 sites recruiting
  • 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
    • Ling Dai · Contact · +86 13853388549
    Recruiting
08

References and documents

Publications

  • 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. PubMed 30822272 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 31, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01703637
Lead sponsor
Lin Liao
Responsible party
Lin Liao (chief of endocrinology department at Qianfoshan Hospital, Qianfoshan Hospital) — Sponsor-investigator
First posted
Oct 10, 2012
Start date
Oct 2012
Primary completion
Dec 2016 (estimated)
Last update
Mar 31, 2016

Study contacts

Lin Liao, MD
Contact
liaolin@medmail.com.cn
8615168888260
Lin Liao, MD
study chair · Qianfoshan Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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