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Diabetes Mellitus, Type 2Phase 4VISA-T2DMNCT02999841

Effect of Acarbose and Vildagliptin on Visceral Fat Distribution in Newly Diagnosed Type 2 Diabetes Patients

A Phase 4 study testing Acarbose and Vildagliptin in people with Diabetes Mellitus, Type 2 and Obesity, run by Peking University at 1 site 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Focusing on newly diagnosed type 2 diabetes participants with overweight and obesity (24kg/m2 ≤ body mass index ≤ 30kg/m2). 50 participants per arm (acarbose \& lifestyle combination / vildagliptin \& lifestyle combination), using abdominal computed tomography scans and other methods to evaluate the effects of… Read more about this study

Who is it for?
Ages 30 to 70 years
Conditions the study is for
Diabetes Mellitus, Type 2, Obesity
What is being tested?
Acarbose and Vildagliptin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteChina
Study dates
Mar 2016to Jan 2018
Phase
Phase 4
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 30 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All patients was diagnosed within the past 12 months with type 2 diabetes patients (WHO, 1999 criteria ).
  • Not received oral anti-diabetic drugs or has been on short-term(1month) treatment that had been discontinued 3 months before enrollment.
  • 30 ≤ Age ≤ 70 years old, male or female.
  • HbA1c between 7% and 9% (7.0% ≤ HbA1c ≤9.0%).
  • 24 ≤ BMI ≤ 30 kg/m2.
  • Written Informed consent.

Who cannot join

  • Subject with type 1 diabetes or gestational diabetes mellitus and other specific types DM.
  • Those who can not tolerate AGI or who is suffering GI disease.
  • Subject with repeated severe hypoglycemia and/or unawareness of hypoglycemia.
  • Known or suspected allergy to trial product(s) or related products.
  • Females of child bearing potential who are pregnant, breast-feeding or have the intention of becoming pregnant or not using adequate contraceptive methods throughout the trial
  • Impaired liver function, defined as ALT≥2 or AST≥ 2 times upper referenced limit times upper normal limit.
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  • Any other clinically significant condition or major systemic diseases, including serious coronary heart disease, cardiovascular disease, cancer, TB, acute infection.
  • Endocrine diseases (hypo thyroidism, hyperthyroidism,Cushing's syndrome).
  • Uncontrolled hypertension(SBP≥180mmHg and/or DBP≥100mmHg).
  • Diabetic ketoacidosis; or hyperosmolar non-ketotic coma.
  • Concomitant treatment which influences blood glucose and bodyweight.
  • Impaired renal function(Cr≥ 1.5 mg/dl in male or Cr≥1.4 mg/dl in female).
  • Mental disorders; drug or other substance misuse.
  • Participation in any drug clinical trials during the past 3 months before enrolment.

Trial locations and contacts

1 site in 1 country.

Linong Ji, MD contact

+86 10 8832 4108

China1 site, 1 recruiting

  • Beijing Pinggu Hospital

    Beijing, Beijing Municipality, 101200

    Yufeng Li, MD, +86 139 1108 0328

    Yufeng Li, MD

    Recruiting

Other trials in China

About this study

Official title: Effect of Acarbose and Vildagliptin on Visceral Fat Distribution in Overweight and Obesity Patients With Newly Diagnosed Type 2 Diabetes Mellitus: A Randomized Control Study

Focusing on newly diagnosed type 2 diabetes participants with overweight and obesity (24kg/m2 ≤ body mass index ≤ 30kg/m2).

50 participants per arm (acarbose \& lifestyle combination / vildagliptin \& lifestyle combination), using abdominal computed tomography scans and other methods to evaluate the effects of acarbose and vildagliptin on visceral fat distribution in overweight and obesity patients with newly diagnosed type 2 diabetes.

Being tested
Acarbose, Vildagliptin
Keywords
Visceral fat
Medical subject headings
Diabetes Mellitus, Type 2, Obesity

What participants receive

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

  • AcarboseDrug

    Also called Glucobay (Acarbose Tablets)

    1-2 week: 50mg tid; 3-24 week: 100mg tid.

  • VildagliptinDrug

    Also called Galvus (Vidagliptin Tablets)

    1-24 week: 50mg bid

Study groups in NCT02999841
Study groupRoleWhat they receive
Group AExperimentalAcarbose
Receives: Drug: Acarbose
Group BActive comparatorVildagliptin
Receives: Drug: Vildagliptin

What is being measured

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

  1. Change of the visceral fat area in square centimeter assessed by abdominal CT scans from baseline to 24 weeks.

    Measured: 24 weeks

Secondary outcomes (13)

  1. Change of body weight in kilograms measured by investigators from baseline to 24 weeks.

    Measured: 24 weeks

  2. Change of waist circumstance in centimeters measured by investigators from baseline to 24 weeks.

    Measured: 24 weeks

  3. Change of body mass index in kg/m^2 measured by investigators from baseline to 24 weeks.

    Measured: 24 weeks

  4. Change of the subcutaneous fat area in square centimeters assessed by abdominal CT scans from baseline to 24 weeks.

    Measured: 24 weeks

  5. Change of hemoglobin A1c in percents from baseline to 24 weeks.

    Measured: 24 weeks

  6. Change of hemoglobin fasting plasma glucose in millimols per liter from baseline to 24 weeks.

    Measured: 24 weeks

  7. Change of hemoglobin 2-hour-post-prandial plasma glucose in millimols per liter from baseline to 24 weeks.

    Measured: 24 weeks

  8. Change of triglyceride in millimols per liter from baseline to 24 weeks.

    Measured: 24 weeks

  9. Change of total cholesterol in millimols per liter from baseline to 24 weeks.

    Measured: 24 weeks

  10. Change of low-density lipoprotein-cholesterol in millimols per liter from baseline to 24 weeks.

    Measured: 24 weeks

  11. Change of high-density lipoprotein-cholesterol in millimols per liter from baseline to 24 weeks.

    Measured: 24 weeks

  12. Change of insulin in international units per liter from baseline to 24 weeks.

    Measured: 24 weeks

  13. Change of brain natriuretic peptide in nanograms per milliliter from baseline to 24 weeks.

    Measured: 24 weeks

Timeline

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

  1. First posted21 Dec 2016 (estimated)
  2. Study startMar 2016
  3. Primary completionDec 2017 (estimated)
  4. Study completionJan 2018 (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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02999841
Sponsor's protocol ID
2119000273
Acronym
VISA-T2DM
Status last verified
Dec 2016
First submitted
15 Mar 2016
Last updated
21 Dec 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No: Do not share data.

Publications

  • Ibrahim MM. Subcutaneous and visceral adipose tissue: structural and functional differences. Obes Rev. 2010 Jan;11(1):11-8. doi: 10.1111/j.1467-789X.2009.00623.x. Epub 2009 Jul 28.

    PubMed 19656312

  • Schernthaner GH, Schernthaner G. Insulin resistance and inflammation in the early phase of type 2 diabetes: potential for therapeutic intervention. Scand J Clin Lab Invest Suppl. 2005;240:30-40. doi: 10.1080/00365510500236119.

    PubMed 16112958

  • Monami M, Iacomelli I, Marchionni N, Mannucci E. Dipeptydil peptidase-4 inhibitors in type 2 diabetes: a meta-analysis of randomized clinical trials. Nutr Metab Cardiovasc Dis. 2010 May;20(4):224-35. doi: 10.1016/j.numecd.2009.03.015. Epub 2009 Jun 9.

    PubMed 19515542

  • Kodama N, Tahara N, Tahara A, Honda A, Nitta Y, Mizoguchi M, Kaida H, Ishibashi M, Abe T, Ikeda H, Narula J, Fukumoto Y, Yamagishi S, Imaizumi T. Effects of pioglitazone on visceral fat metabolic activity in impaired glucose tolerance or type 2 diabetes mellitus. J Clin Endocrinol Metab. 2013 Nov;98(11):4438-45. doi: 10.1210/jc.2013-2920. Epub 2013 Sep 12.

    PubMed 24030946

  • Yang X, Zhang X, Sun C, Zhao C, Kong X, Zhao M, Ji L, Li Y. Effect of acarbose and vildagliptin on plasma trimethylamine N-oxide levels in patients with type 2 diabetes mellitus: a 6-month, two-arm randomized controlled trial. Front Endocrinol (Lausanne). 2025 May 6;16:1575087. doi: 10.3389/fendo.2025.1575087. eCollection 2025.

    PubMed 40395816

  • Zhang X, Ren H, Zhao C, Shi Z, Qiu L, Yang F, Zhou X, Han X, Wu K, Zhong H, Li Y, Li J, Ji L. Metagenomic analysis reveals crosstalk between gut microbiota and glucose-lowering drugs targeting the gastrointestinal tract in Chinese patients with type 2 diabetes: a 6 month, two-arm randomised trial. Diabetologia. 2022 Oct;65(10):1613-1626. doi: 10.1007/s00125-022-05768-5. Epub 2022 Aug 5.

    PubMed 35930018

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Acarbose and Vildagliptin in people with Diabetes Mellitus, Type 2 and Obesity, run by Peking University at 1 site 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 6 inclusion and 14 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 21 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Linong Ji, MD (+86 10 8832 4108), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of the visceral fat area in square centimeter assessed by abdominal CT scans from baseline to 24 weeks. (time frame: 24 weeks). 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 NCT02999841, which also lists 6 linked publications.

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 21 Dec 2016; AzTrials last refreshed its copy on 8 Nov 2026.

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