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Type 2 Diabetes MellitusFLATNCT03805191

A Study for Sufficient Acarbose Decreased Glucose Excursion in Type 2 Diabetic Patients

An observational study of Type 2 Diabetes Mellitus and Poor Glycemic Control, run by Qilu Hospital of Shandong 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 The sponsor has not verified this record for over two years, so it may be out of date.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

This is a multicentre observational study to investigate the improvement in glucose fluctuation of sufficient acarbose therapy on type 2 diabetes patient with high blood glucose fluctuation Read more about this study

Who is it for?
Ages 18 years and older
How many people
900 participants
Where
1 siteChina
Study dates
1 Jan 2019to 30 Dec 2022
Phase
Observational
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: According to the course of diabetes, enrolled patients are divided into three groups: A (< 5Y), B (5-10y), C (> 10Y). According to the level of HbA1c,enrolled patients are divided into three groups:I (7%-8%), II (8%-9%), and III (9%-10%). Then there are nine groups, namely AI, AII, AIII, BI, BII, BIII, CI, CII, and CIII.100 patients are enrolled in each group.All enrolled patiens are 900.

Who may be able to join

  • All enrolled patients sign the informed consent. sign the informed consent form.
  • Clinical diagnosis of T2DM(1999 WHO).
  • No acarbose in nearly 3 months.
  • 7% < HbA1c ≤10% .
  • PPGE >2.2mmol/L and LAGE >4.4mmol/L.
  • MAGE > 3.9 mmol/L.
  • The previous therapy remain the same.
  • Contraception is needed for women of child-bearing age until 28 days after the end.

Who cannot join

  • Women of childbearing potential unable or unwilling to use acceptable birth control, or women who are pregnant or breastfeeding.
  • Replacement or chronic systemic corticosteroid therapy. Cytochrome P450 3A4 enzyme inducer or inhibitor therapy.Antiviral therapy for immunodeficiency disease.
  • History of gastrointestinal disease or surgery including Roemheld Syndrome, severe hernia, intestinal obstruction, intestinal ulcer, gastroenterostomy, enterectomy, bariatric surgery or lap-band procedure.
  • Known immunocompromised status, including but not limited to, individuals who had undergone organ transplantation or acquired immunodeficiency syndrome (AIDS).
  • History of hemoglobinopathy .
  • Any subject who was currently abusing alcohol or other drugs or had done so within the last 12 months.
Show all 24Show fewer
  • There are contraindications listed in the acarbose instructions.
  • History of acute or chronic pancreatitis, or current acute or chronic pancreatitis.
  • Type 1 diabetees mellitus.
  • History of diabetic ketoacidosis or hyperosmolar nonketosis coma in recent 1 month.
  • Patients with clinically apparent hepatobiliary disease, including but not limited to chronic active hepatitis and/or severe hepatic insufficiency. Alanine Aminotransferase(ALT) or Aspartate Aminotransferase(AST) > 3x upper limit of normal (ULN), or serum total bilirubin (TB) >34.2 μmol/L (>2 mg/dL).
  • Patients with following renal disease history or renal disease related features:
  • History of unstable or rapidly progressing renal disease;
  • Patients with moderate /severe renal impairment or end-stage renal disease (eGFR< 60 mL/min/1.73 m2);
  • Urinary albumin: creatinine ratio >1800 mg/g;
  • Serum creatinine (Cr) ≥133 μmol/L (≥1.50 mg/dL) for male subjects; Serum Cr≥124 μmol/L (≥1.40 mg/dL) for female subjects;
  • Conditions of congenital renal glycosuria.
  • Any of the following cardiovascular diseases within 6 months of the enrollment visit:
  • Myocardial infarction;
  • Cardiac surgery or revascularization (coronary artery bypass graft/percutaneous transluminal coronary angioplasty);
  • Unstable angina;
  • Congestive heart failure New York Heart Association Class III or IV;
  • Transient ischemic attack or significant cerebrovascular disease.
  • Any subject , in the judgment of the investigator, was at risk that might affect the interpretation of efficacy or safety data or the conduct ion of the study，including laboratory and physical examination or ECG.

Trial locations and contacts

1 site in 1 country.

Jianjun Dong, PhD.MD contact

86-18560083978

dongjianjun@sdu.edu.cn

Piyun Gong, MM contact

86-18560087970

gongpeiyunshanda@163.com

China1 site, 1 recruiting

  • Qilu Hospital of Shandong University

    Jinan

    Jianjun Dong, PhD. MD., 86-18560083978, dongjianjun@sdu.edu.cn

    Piyun Gong, MM., 86-18560087970, gongpeiyunshanda@163.com

    Recruiting

Other trials in China

About this study

Official title: A Multicentre Observational Study to Investigate the Improvement in Glucose FLuctuation of Sufficient Acarbose Therapy on Type 2 Diabetes Patient With High Blood Glucose Fluctuation

This is a multicentre observational study to investigate the improvement in glucose fluctuation of sufficient acarbose therapy on type 2 diabetes patient with high blood glucose fluctuation

Read the detailed description

Acarbose competitively inhibits the a-glycosidase on the surface of epithelial cells from the duodenum and small intestine, delays the metabolism and assimilation of carbohydrates, and thus effectively decreases postprandial blood glucose(PBG) as well as the risk of hypoglycemia before the next meal.Acarbose is now used as the preferred drug for some patients with prediabetes and newly diagnosed type 2 diabetes millitus(T2DM).This study aims to investigate the glycemic excursions with different courses and glycated hemoglobin A1c(HbA1c) levels after treated three months with acarbose.To minimize gastrointestinal side effects，starting dosage of acarbose of 50 mg is given orally three times daily for 10 days(with the first bite) of each main meal. Glycemic excursions are evaluated using the mean amplitude of glycemic excursions (MAGE), the postprandial glycemic excursions (PPGE) and the largest amplitude of glycemic excursions (LAGE).Freestyle Libre flash glucose monitoring system (FGMS，Abbott Laboratories,USA) was administered in this study. According to the standard Freestyle Libre Pro operating guidelines, the FGMS is installed in all participants to monitor glucose levels of interstitial fluid for 14 consecutive days. The glucose sensor is inserted into the subcutaneous tissue of upper arm at 8:00-9:00 in the morning.Glucose concentrations at 7 preset times per day (before meals, 2-h after meals and at bedtime) were determined with VivaChek Ino Smart（VivaChek Laboratories, Inc., USA) every two weeks.Four days before using acarbose and five weeks after using acarbose, FGMS was using to monitor the continuous glucose.MAGE was calculated for each subject by taking the arithmetic mean of FGM values increased or decreased (from nadirs to peaks or vice versa) when both ascending and descending segments exceeded the value of one standard deviation (SD) of the FGM values for 24-h period.The primary endpoint of the study is the extent of change in MAGE.Secondary endpoints are changes in PPGE,LAGE and HbA1c. Gene polymorphism is detected for enrolled patient with poor acarbose effect.

Keywords
Glycemic excursions, Acarbose, Continuous glucose monitoring
Medical subject headings
Diabetes Mellitus, Type 2

What is being measured

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

  1. The extent of change in MAGE

    Mean absolute glucose excursions (MAGE) was calculated to assess intraday glucose variability. The difference between the consecutive peaks and nadirs exceeding one standard deviation (SD) of the daily mean blood glucose (MBG) level was expressed as absolute glucose excursion (AGE). MAGE was an arithmetic mean of all absolute AGEs.The average MAGE of the last three days of the eighth week are compared with the baseline（The average MAGE of the three days before using acarbose).The extent of change in MAGE is numerical value to to assess glucose variability.

    Measured: 8 weeks

Secondary outcomes (2)

  1. The extent of change in PPGE,LAGE

    Postprandial glucose excursion (PPGE) is calculated as the peak value of glucose after meals minus the glucose level at the beginning of each meal to evaluate the influence of meals on glucose fluctuation.Largest amplitude of glycemic excursions (LAGE) is calculated as the maximum minus the minimum blood glucose levels measured in one day.The average PPGE、LAGE of the last three days of the eighth week compared with the baseline（The average PPGE、LAGE of the three days before using acarbose）.

    Measured: 8 weeks

  2. The control rate of HbA1c

    When HbA1c<7% was considered as the criteria, the control rate of HbA1c after 12 weeks.

    Measured: 12 weeks

Timeline

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

  1. First posted15 Jan 2019
  2. Study start1 Jan 2019
  3. Primary completion30 Nov 2020 (estimated)
  4. Study completion30 Dec 2022 (estimated)

Resources

More details

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

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
900 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03805191
Sponsor's protocol ID
RD-OI-1257
Acronym
FLAT
Status last verified
Apr 2019
First submitted
10 Jan 2019
Last updated
12 Apr 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Xu Y, Wang L, He J, Bi Y, Li M, Wang T, Wang L, Jiang Y, Dai M, Lu J, Xu M, Li Y, Hu N, Li J, Mi S, Chen CS, Li G, Mu Y, Zhao J, Kong L, Chen J, Lai S, Wang W, Zhao W, Ning G; 2010 China Noncommunicable Disease Surveillance Group. Prevalence and control of diabetes in Chinese adults. JAMA. 2013 Sep 4;310(9):948-59. doi: 10.1001/jama.2013.168118.

    PubMed 24002281

  • Poolsup N, Suksomboon N, Rattanasookchit S. Meta-analysis of the benefits of self-monitoring of blood glucose on glycemic control in type 2 diabetes patients: an update. Diabetes Technol Ther. 2009 Dec;11(12):775-84. doi: 10.1089/dia.2009.0091.

    PubMed 20001678

  • The relationship of glycemic exposure (HbA1c) to the risk of development and progression of retinopathy in the diabetes control and complications trial. Diabetes. 1995 Aug;44(8):968-83.

    PubMed 7622004

  • Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998 Sep 12;352(9131):837-53.

    PubMed 9742976

  • Monnier L, Colette C, Dunseath GJ, Owens DR. The loss of postprandial glycemic control precedes stepwise deterioration of fasting with worsening diabetes. Diabetes Care. 2007 Feb;30(2):263-9. doi: 10.2337/dc06-1612.

    PubMed 17259492

  • Maia FF, Araujo LR. Efficacy of continuous glucose monitoring system (CGMS) to detect postprandial hyperglycemia and unrecognized hypoglycemia in type 1 diabetic patients. Diabetes Res Clin Pract. 2007 Jan;75(1):30-4. doi: 10.1016/j.diabres.2006.05.009. Epub 2006 Jun 27.

    PubMed 16806560

  • Mastrototaro J. The MiniMed Continuous Glucose Monitoring System (CGMS). J Pediatr Endocrinol Metab. 1999;12 Suppl 3:751-8. No abstract available.

    PubMed 10626266

  • Ginsberg BH. The FDA panel advises approval of the first continuous glucose sensor. Diabetes Technol Ther. 1999 Summer;1(2):203-4. doi: 10.1089/152091599317431. No abstract available.

    PubMed 11475294

  • Monnier L, Colette C, Owens DR. Glycemic variability: the third component of the dysglycemia in diabetes. Is it important? How to measure it? J Diabetes Sci Technol. 2008 Nov;2(6):1094-100. doi: 10.1177/193229680800200618.

    PubMed 19885298

  • Guerci B. [Asymptomatic glycemic instability: how to measure it and which clinical applications? ]. Diabetes Metab. 2003 Apr;29(2 Pt 1):179-88. French.

    PubMed 12746641

  • Hirsch IB, Brownlee M. Should minimal blood glucose variability become the gold standard of glycemic control? J Diabetes Complications. 2005 May-Jun;19(3):178-81. doi: 10.1016/j.jdiacomp.2004.10.001.

    PubMed 15866065

  • Del Prato S. In search of normoglycaemia in diabetes: controlling postprandial glucose. Int J Obes Relat Metab Disord. 2002 Sep;26 Suppl 3:S9-17. doi: 10.1038/sj.ijo.0802172.

    PubMed 12174318

  • Yang W, Liu J, Shan Z, Tian H, Zhou Z, Ji Q, Weng J, Jia W, Lu J, Liu J, Xu Y, Yang Z, Chen W. Acarbose compared with metformin as initial therapy in patients with newly diagnosed type 2 diabetes: an open-label, non-inferiority randomised trial. Lancet Diabetes Endocrinol. 2014 Jan;2(1):46-55. doi: 10.1016/S2213-8587(13)70021-4. Epub 2013 Oct 18.

    PubMed 24622668

  • Li S, Xiao J, Ji L, Weng J, Jia W, Lu J, Zhou Z, Guo X, Liu J, Shan Z, Zhu D, Chen L, Zhao Z, Tian H, Ji Q, Ge J, Li Q, Lin L, Yang Z, He J, Yang W; China National Diabetes and Metabolic Disorders Study Investigators. BMI and waist circumference are associated with impaired glucose metabolism and type 2 diabetes in normal weight Chinese adults. J Diabetes Complications. 2014 Jul-Aug;28(4):470-6. doi: 10.1016/j.jdiacomp.2014.03.015. Epub 2014 Apr 1.

    PubMed 24809931

  • Ma RC. Acarbose: an alternative to metformin for first-line treatment in type 2 diabetes? Lancet Diabetes Endocrinol. 2014 Jan;2(1):6-7. doi: 10.1016/S2213-8587(13)70107-4. Epub 2013 Oct 18. No abstract available.

    PubMed 24622656

Questions about this trial

What is this clinical trial studying?

An observational study of Type 2 Diabetes Mellitus and Poor Glycemic Control, run by Qilu Hospital of Shandong 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 8 inclusion and 24 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 12 Apr 2019. 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.

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 Jianjun Dong, PhD.MD (86-18560083978, dongjianjun@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The extent of change in MAGE (time frame: 8 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 NCT03805191, which also lists 28 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 12 Apr 2019; AzTrials last refreshed its copy on 30 Oct 2026.

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