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

NCT03805191 | Unknown

• 1 other identifier: RD-OI-1257
• Study Type: observational
• Target: 900
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Type 2 Diabetes Mellitus; Poor Glycemic Control

Keywords

Glycemic excursions; Acarbose; Continuous glucose monitoring

Outcome Measures

Primary Outcomes (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.

  8 weeks

Secondary Outcomes (2)

• The extent of change in PPGE,LAGE

  8 weeks

• The control rate of HbA1c

  12 weeks

Other Outcomes (1)

• Gene polymorphism

  12 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• All enrolled patients sign the informed consent. sign the informed consent form.
• Clinical diagnosis of T2DM(1999 WHO).
• No acarbose in nearly 3 months.
• % \< 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead
• Bayer: collaborator

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, China

RECRUITING

Related Publications (28)

• 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.

  PMID: 24002281 BACKGROUND

• 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.

  PMID: 20001678 BACKGROUND

• 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.

  PMID: 7622004 BACKGROUND

• 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.

  PMID: 9742976 BACKGROUND

• 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.

  PMID: 17259492 BACKGROUND

• 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.

  PMID: 16806560 BACKGROUND

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

  PMID: 10626266 BACKGROUND

• 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.

  PMID: 11475294 BACKGROUND

• 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.

  PMID: 19885298 BACKGROUND

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

  PMID: 12746641 BACKGROUND

• 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.

  PMID: 15866065 BACKGROUND

• 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.

  PMID: 12174318 BACKGROUND

• 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.

  PMID: 24622668 BACKGROUND

• 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.

  PMID: 24809931 BACKGROUND

• 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.

  PMID: 24622656 BACKGROUND

• 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.

  PMID: 24767162 BACKGROUND

• 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.

  PMID: 22809112 BACKGROUND

• 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.

  PMID: 23631607 BACKGROUND

• 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.

  PMID: 22078152 BACKGROUND

• 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.

  PMID: 21813293 BACKGROUND

• 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.

  PMID: 28725273 BACKGROUND

• 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.

  PMID: 23704688 BACKGROUND

• 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.

  PMID: 23412078 BACKGROUND

• 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.

  PMID: 23438184 BACKGROUND

• 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.

  PMID: 28858080 BACKGROUND

• 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.

  PMID: 27043224 BACKGROUND

• 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.

  PMID: 12673780 BACKGROUND

• 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.

  PMID: 28713663 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• 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

  Jining Medical University

  PRINCIPAL INVESTIGATOR

• Dadong Fei, MD

  Zaozhuang Municipal Hospital

  PRINCIPAL INVESTIGATOR

• Guangling Xu, MD

  Guanxian people's hospital of liaocheng city

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianjun Dong, PhD.MD

CONTACT

86-18560083978; dongjianjun@sdu.edu.cn

Piyun Gong, MM

CONTACT

86-18560087970; gongpeiyunshanda@163.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2019
• First Posted: January 15, 2019
• Study Start: January 1, 2019
• Primary Completion: November 30, 2020
• Study Completion: December 30, 2022
• Last Updated: April 12, 2019

Record last verified: 2019-04

Locations

CN (1)