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Type 2 Diabetes MellitusNCT01703637

Efficacy and Safety Comparative Study of Sitagliptin,Vildagliptin and Saxagliptin

A study testing Sitagliptin, Vildagliptin and Saxagliptin in people with Type 2 Diabetes Mellitus, run by Lin Liao at 8 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 78 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Sitagliptin, Vildagliptin and Saxagliptin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
8 sitesChina
Study dates
Oct 2012to Dec 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 78 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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%

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

8 sites in 1 country.

Lin Liao, MD contact

8615168888260

liaolin@medmail.com.cn

8 sites in 1 country

China8 sites, 8 recruiting

  • YuCheng people's hospital

    Dezhou, Shandong, 253000

    Pengfei Li, lpf9669@163.com

    Recruiting

  • Hospital of SINOTRUK

    Jinan, Shandong, 250010

    Xiling Fu, fxl1936@163.com

    Recruiting

  • Jinan central hospital

    Jinan, Shandong, 250010

    Shuguang Pang, shuguangpang@163.com

    Recruiting

  • The jinan military region general hospital

    Jinan, Shandong, 250010

    Zhaoshun Jiang, zhaoshunjiang@sohu.com

    Recruiting

  • Qianfoshan Hospital

    Jinan, Shandong, 250012

    Lin Liao, MD, 8615168888260, liaolin@medmail.com.cn

    Recruiting

  • People's Hospital of Qingdao Chengyang

    Qingdao, Shandong, 266100

    Xiaopang Rao, 123raoxiaopang@163.com

    Recruiting

  • Zibo central hospital

    Zibo, Shandong, 255000

    Xiaodong Zhao, 19xiaodong@163.com

    Recruiting

  • Zibo eighth people's hospital

    Zibo, Shandong, 255000

    Ling Dai, +86 13853388549

    Recruiting

Other trials in China

About this study

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

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.

Being tested
Sitagliptin, Vildagliptin, Saxagliptin
Keywords
Sitagliptin, Vildagliptin, Saxagliptin, Diabetes Mellitus, Type 2
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SitagliptinDrug

    Also called Januvia

    • 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

  • VildagliptinDrug

    Also called Galvus

    • 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

  • SaxagliptinDrug

    Also called Onglyza

    • 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
Study groups in NCT01703637
Study groupRoleWhat they receive
SitagliptinExperimentalDrug: sitagliptin sitagliptin 100mg tablet by mouth , once daily for 12 weeks
Receives: Drug: Sitagliptin
VildagliptinExperimentalDrug: vildagliptin saxagliptin 50mg tablet by mouth , twice daily for 12 weeks
Receives: Drug: Vildagliptin
SaxagliptinExperimentalDrug: saxagliptin saxagliptin 5mg tablet by mouth , once daily for 12 weeks
Receives: Drug: Saxagliptin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Baseline and Week 12

Secondary outcomes (11)

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

    Measured: Baseline to Week 12

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

    Measured: Baseline and Week 12

  3. Change From Baseline in Fasting Insulin at Week 12

    Measured: Baseline to Week 12

  4. Change From Baseline in Fasting Glucagon at Week 12

    Measured: Baseline and Week 12

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

    Measured: Baseline and Week 12

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

    Measured: Baseline and Week 12

  7. Change From Baseline in abdominal perimeter at Week 12

    Measured: Baseline and Week 12

  8. Change From Baseline in Body Weight at Week 12

    Measured: 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)

    Measured: Baseline and Week 12

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

    Measured: Baseline and Week 12

  11. The side effect of each drug.

    Measured: Baseline to week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2012 (estimated)
  2. Study startOct 2012
  3. Primary completionDec 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01703637
Sponsor's protocol ID
qfsnfm-001
Status last verified
Mar 2016
First submitted
6 Oct 2012
Last updated
31 Mar 2016
Results posted
No
Data monitoring committee
Yes

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

Questions about this trial

What is this clinical trial studying?

A study testing Sitagliptin, Vildagliptin and Saxagliptin in people with Type 2 Diabetes Mellitus, run by Lin Liao at 8 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Lin Liao, MD (8615168888260, liaolin@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Hemoglobin A1c (A1C) Levels at Week 12 (time frame: Baseline and Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01703637, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2016.

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