A Study for Sufficient Acarbose Decreased Glucose Excursion in Type 2 Diabetic Patients (FLAT)
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
Study Overview
Status
Status
Conditions
Conditions
Detailed Description
Study Type
Study Type
Enrollment (Anticipated)
Enrollment
Contacts and Locations
Study Contact
Study Contact
- Name: Jianjun Dong, PhD.MD
- Phone Number: 86-18560083978
- Email: dongjianjun@sdu.edu.cn
Study Contact Backup
- Name: Piyun Gong, MM
- Phone Number: 86-18560087970
- Email: gongpeiyunshanda@163.com
Study Locations
-
-
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Jinan, China
- Recruiting
- Qilu Hospital of Shandong University
-
Contact:
- Jianjun Dong, PhD. MD.
- Phone Number: 86-18560083978
- Email: dongjianjun@sdu.edu.cn
-
Contact:
- Piyun Gong, MM.
- Phone Number: 86-18560087970
- Email: gongpeiyunshanda@163.com
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The extent of change in MAGE
Time Frame: 8 weeks
|
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.
|
8 weeks
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The extent of change in PPGE,LAGE
Time Frame: 8 weeks
|
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).
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8 weeks
|
|
The control rate of HbA1c
Time Frame: 12 weeks
|
When HbA1c<7% was considered as the criteria, the control rate of HbA1c after 12 weeks.
|
12 weeks
|
Other Outcome Measures
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gene polymorphism
Time Frame: 12 weeks
|
Gene polymorphism is detected for enrolled patient with poor acarbose effect.
|
12 weeks
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Lin Liao, MD, Qianfoshan Hospital
- Principal Investigator: Yuping Zhou, MD, Weihai Municipal Hospital
- Principal Investigator: Shuguang Pang, MD, Jinan Central Hospital
- Principal Investigator: Fei Wang, MD, Huangdao Branch of Affiliated Hospital of Medical College,Qingdao University
- Principal Investigator: Yongjun Jin, MD, Yantai Branch of Affiliated Binzhou Medical College
- Principal Investigator: Tianying Xu, MD, People's Hospital of Qihe County
- Principal Investigator: Guangzhen Zhang, MD, Liaocheng People's Hospital
- Principal Investigator: Yunfeng Zhang, MD, Linyi lanshan district diabetes hospital
- Principal Investigator: Lin Sun, MD, Affiliated Hospital of Jining Medical College
- Principal Investigator: Dadong Fei, MD, Zaozhuang Municipal Hospital
- Principal Investigator: Guangling Xu, MD, Guanxian people's hospital of liaocheng city
Publications and helpful links
General 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.
- 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.
- 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.
- 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. Erratum In: Lancet 1999 Aug 14;354(9178):602.
- 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.
- 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.
- Mastrototaro J. The MiniMed Continuous Glucose Monitoring System (CGMS). J Pediatr Endocrinol Metab. 1999;12 Suppl 3:751-8. No abstract available.
- 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.
- 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.
- Guerci B. [Asymptomatic glycemic instability: how to measure it and which clinical applications? ]. Diabetes Metab. 2003 Apr;29(2 Pt 1):179-88. French.
- 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.
- 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.
- 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. Erratum In: Lancet Diabetes Endocrinol. 2014 Feb;2(2):e4.
- 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.
- 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.
- Chen M, Dou J, Zhuang X, Dong L, Ruan D, Ding J, Zhang Y, Tian Y, Zhao J, Wu J, Fu Y, Huang X, Wang S, Lu J. [An analysis of hypoglycemic agents used among patients with type 2 diabetes in Beijing communities]. Zhonghua Nei Ke Za Zhi. 2014 Feb;53(2):112-5. Chinese.
- Ju-Ming L, Xiao-Hui G, Xiao-Feng L, Yan-Bing L, Li Y, Yao-Ming X. Effects of Nateglinide on Postprandial Plasma Glucose Excursion and Metabolism of Lipids in Chinese Patients with Type 2 Diabetes:A 4-week, randomized, active-control, open-label, parallel-group, multicenter trial. Curr Med Res Opin. 2012 Jul 19. doi: 10.1185/03007995.2012.713340. Online ahead of print.
- Zhou J, Li H, Zhang X, Peng Y, Mo Y, Bao Y, Jia W. Nateglinide and acarbose are comparably effective reducers of postprandial glycemic excursions in chinese antihyperglycemic agent-naive subjects with type 2 diabetes. Diabetes Technol Ther. 2013 Jun;15(6):481-8. doi: 10.1089/dia.2013.0046. Epub 2013 Apr 30.
- Wang JS, Lin SD, Lee WJ, Su SL, Lee IT, Tu ST, Tseng YH, Lin SY, Sheu WH. Effects of acarbose versus glibenclamide on glycemic excursion and oxidative stress in type 2 diabetic patients inadequately controlled by metformin: a 24-week, randomized, open-label, parallel-group comparison. Clin Ther. 2011 Dec;33(12):1932-42. doi: 10.1016/j.clinthera.2011.10.014. Epub 2011 Nov 10.
- Lin SD, Wang JS, Hsu SR, Sheu WH, Tu ST, Lee IT, Su SL, Lin SY, Wang SY, Hsieh MC. The beneficial effect of alpha-glucosidase inhibitor on glucose variability compared with sulfonylurea in Taiwanese type 2 diabetic patients inadequately controlled with metformin: preliminary data. J Diabetes Complications. 2011 Sep-Oct;25(5):332-8. doi: 10.1016/j.jdiacomp.2011.06.004. Epub 2011 Aug 2.
- Nomoto H, Miyoshi H, Sugawara H, Ono K, Yanagiya S, Oita M, Nakamura A, Atsumi T. A randomized controlled trial comparing the effects of dapagliflozin and DPP-4 inhibitors on glucose variability and metabolic parameters in patients with type 2 diabetes mellitus on insulin. Diabetol Metab Syndr. 2017 Jul 17;9:54. doi: 10.1186/s13098-017-0255-8. eCollection 2017.
- Makdissi A, Chaudhuri A, Kuhadiya N, Batra M, Dandona P. Comment on: Rizzo et al. Reduction of oxidative stress and inflammation by blunting daily acute glucose fluctuations in patients with type 2 diabetes: role of dipeptidyl peptidase-IV inhibition. Diabetes Care 2012;35:2076-2082. Diabetes Care. 2013 Jun;36(6):e80. doi: 10.2337/dc12-2220. No abstract available.
- Polidori D, Sha S, Mudaliar S, Ciaraldi TP, Ghosh A, Vaccaro N, Farrell K, Rothenberg P, Henry RR. Canagliflozin lowers postprandial glucose and insulin by delaying intestinal glucose absorption in addition to increasing urinary glucose excretion: results of a randomized, placebo-controlled study. Diabetes Care. 2013 Aug;36(8):2154-61. doi: 10.2337/dc12-2391. Epub 2013 Feb 14.
- Deshmukh AB, Patel MC, Mishra B. SGLT2 inhibition: a novel prospective strategy in treatment of diabetes mellitus. Ren Fail. 2013;35(4):566-72. doi: 10.3109/0886022X.2013.766560. Epub 2013 Feb 25.
- Wu H, Liu J, Lou Q, Liu J, Shen L, Zhang M, Lv X, Gu M, Guo X. Comparative assessment of the efficacy and safety of acarbose and metformin combined with premixed insulin in patients with type 2 diabetes mellitus. Medicine (Baltimore). 2017 Sep;96(35):e7533. doi: 10.1097/MD.0000000000007533.
- Wang JS, Lee IT, Lee WJ, Lin SD, Su SL, Tu ST, Tseng YH, Lin SY, Sheu WH. Glycemic excursions are positively associated with HbA1c reduction from baseline after treatment with acarbose in patients with type 2 diabetes on metformin monotherapy. J Diabetes. 2017 Mar;9(3):248-255. doi: 10.1111/1753-0407.12406. Epub 2016 May 31.
- Park S, Choi SB. Induction of long-term normoglycemia without medication in Korean type 2 diabetes patients after continuous subcutaneous insulin infusion therapy. Diabetes Metab Res Rev. 2003 Mar-Apr;19(2):124-30. doi: 10.1002/dmrr.343.
- Naqvi S, Naveed S, Ali Z, Ahmad SM, Asadullah Khan R, Raj H, Shariff S, Rupareliya C, Zahra F, Khan S. Correlation between Glycated Hemoglobin and Triglyceride Level in Type 2 Diabetes Mellitus. Cureus. 2017 Jun 13;9(6):e1347. doi: 10.7759/cureus.1347.
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Anticipated)
Primary Completion
Study Completion (Anticipated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- RD-OI-1257
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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