To Improve the Ability of Early Screening and Diagnosis in Patients With Diabetic Nephropathy

Diabetic Kidney Disease Clinical Trial

Official title:

Healthy China - The Improvement Projects for the Screening Ability of Diabetes and Its Complications And for the Standardized Ability of Diagnosis and Treatment for Patients With Early Diabetic Nephropathy

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05047471
• Other study ID #: 2021BY01
• Status: Enrolling by invitation
• Start date: December 25, 2021
• Est. completion date: June 2023

Study information

• Verified date: May 2022
• Source: Beijing Great Physician Commonweal Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a large-scale, multi-center, observational study. It is planned to establish a large database of 10,000 patients with type 2 diabetes mellitus to investigate the prevalence, awareness and screening rates of diabetes kidney disease (DKD), and provide real-world data on the efficacy and safety of sodium glucose cotransporter 2 inhibitors (SGLT2i) in patients with type 2 diabetes mellitus (T2DM).

Description:

Among the various complications of diabetes mellitus, DKD is considered as a major threat and is one of the manifestations of diabetic microangiopathy. it is one of the main causes of death for patients with T2DM.

Albuminuria is the earliest manifestation of DKD, which is mostly asymptomatic at the early stage, if the albuminuria is poorly controlled, it may develop into clinical DKD. Therefore, it is very important to improve the patients' awareness of DKD, regularly screen early kidney diseases and use drugs rationally.

In order to promote the standardization of diagnosis and treatment of patients with DKD, improve the knowledge and screening rate of patients with DKD, help the formation of health literacy, healthy behavior and lifestyle, the investigators planned the study.

STUDY OBJECTIVES:

1. To understand the epidemiological disease burden of DKD in China, and to investigate the prevalence rate, awareness rate and screening rate of DKD;

2. To understand the treatment status of patients with DKD in China;

3. To provide real-world data on the efficacy and safety of SGLT2i in the treatment of DKD in China;

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 10000
• Est. completion date: June 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• It is known that patients with T2DM has a history of more than 12 months (the WHO1999 Standard) and is treated with at least one anti-diabetic agent.

• Gender and age: men and women who are at least 18 years old with informed consent.

• Patients are willing and able to provide written informed consent before participating in this study.

Exclusion Criteria:

• Type 1 diabetes mellitus (DM)

• Patients with severe ketosis, diabetic coma, severe infection or severe trauma

• Perioperative patients

• Patients with severe renal impairment and advanced nephropathy (eGFR < 45 ml/min/1.73m2)

• Renal transplant patients

• Patients are participating in or have participated in any other clinical trials in the past 3 months

• Any disease with a life expectancy of less than 2 years according to the clinical judgment of the investigator

• Pregnant or lactating women

• Patients judged by the investigator to be unsuitable for participating in the study.

Related Conditions & MeSH terms

• Diabetic Kidney Disease
• Diabetic Nephropathies
• Kidney Diseases

Locations

Country	Name	City	State
China	Airport Area of Peking University Third Hospital	Beijing
China	Beijing Haidian Hospital	Beijing
China	Beijing Luhe Hospital, Capital Medical University	Beijing
China	Peking University Third Hospital	Beijing
China	Peking University Third Hospital Yanqing Hospital	Beijing
China	Strategic Support Force Specialty Medical Center	Beijing
China	The 3th Medical Center of Chinese PLA General Hospital	Beijing
China	The 4th Medical Center of Chinese PLA General Hospital	Beijing
China	The 5th Medical Center of Chinese PLA General Hospital	Beijing
China	The 6th Medical Center of Chinese PLA General Hospital	Beijing
China	The 7th Medical Center of Chinese PLA General Hospital	Beijing
China	The 8th Medical Center of Chinese PLA General Hospital	Beijing
China	The First Medical Center of Chinese PLA General Hospital	Beijing
China	Guangdong Provincial People's Hospital	Guangzhou
China	Guangzhou First People's Hospital	Guangzhou
China	Guangzhou Red Cross Hospital	Guangzhou
China	Nanfang Hospital, Southern Medical University	Guangzhou
China	Sun Yat-sen Memorial Hospital, Sun Yat-sen University	Guangzhou
China	Guiyang First People's Hospital	Guiyang
China	Guiyang Second People's Hospital	Guiyang
China	The Affiliated Hospital of Guizhou Medical University	Guiyang
China	The Second Affiliated Hospital of Guizhou Medical University	Guiyang
China	The First Affiliated Hospital of Anhui Medical University	Hefei
China	NanjingNanjing Drum Tower Hospital( the Affiliated Hospital of Nanjing University Medical School)	Nanjin
China	Nanjing First Hospital	Nanjing
China	Nantong First People's Hospital	Nantong
China	Qingdao Eighth People's Hospital	Qingdao
China	Qingdao Third People's Hospital	Qingdao
China	The Affiliated Hospital of Qingdao University	Qingdao
China	People's Hospital of Rizhao	Rizhao
China	Qingpu Branch of Zhongshan Hospital affiliated to Fudan University	Shanghai
China	Shanghai Minhang District Central Hospital	Shanghai
China	Shanghai Xuhui District Central Hospital	Shanghai
China	Wusong Hospital, Zhongshan Hospital affiliated to Fudan University	Shanghai
China	Zhongshan Hospital affiliated to Fudan University	Shanghai
China	Second Affiliated Hospital of Soochow University	Suzhou
China	The First Affiliated Hospital of Soochow University	Suzhou
China	Taizhou Second People's Hospita	Taizhou
China	Weihai Municipal Hospital	Weihai
China	Renmin Hospital of Wuhan University	Wuhan
China	The Central Hospital of Wuhan	Wuhan
China	Tongji Hospital, Tongji Medical College Of HUST	Wuhan
China	Wuhan No. 1 Hospital	Wuhan
China	Wuhan No. 3 Hospital	Wuhan
China	Wuhan No. 4 Hospital	Wuhan
China	The Affiliated Hospital of Xuzhou Medical University	Xuzhou
China	Yixing People's Hospital	Yixing
China	Zhenjiang First People's Hospital	Zhenjiang
China	The Affiliated Hospital of Zunyi Medical University	Zunyi
China	Zunyi First People's Hospital	Zunyi

Sponsors (1)

Lead Sponsor	Collaborator
Yiming Mu

Country where clinical trial is conducted

China, 

References & Publications (14)

Bailey CJ, Gross JL, Hennicken D, Iqbal N, Mansfield TA, List JF. Dapagliflozin add-on to metformin in type 2 diabetes inadequately controlled with metformin: a randomized, double-blind, placebo-controlled 102-week trial. BMC Med. 2013 Feb 20;11:43. doi: 10.1186/1741-7015-11-43. Erratum in: BMC Med. 2013;11:193. — View Citation

Cannon CP, Pratley R, Dagogo-Jack S, Mancuso J, Huyck S, Masiukiewicz U, Charbonnel B, Frederich R, Gallo S, Cosentino F, Shih WJ, Gantz I, Terra SG, Cherney DZI, McGuire DK; VERTIS CV Investigators. Cardiovascular Outcomes with Ertugliflozin in Type 2 Diabetes. N Engl J Med. 2020 Oct 8;383(15):1425-1435. doi: 10.1056/NEJMoa2004967. Epub 2020 Sep 23. — View Citation

Guo K, Zhang L, Zhao F, Lu J, Pan P, Yu H, Bao Y, Chen H, Jia W. Prevalence of chronic kidney disease and associated factors in Chinese individuals with type 2 diabetes: Cross-sectional study. J Diabetes Complications. 2016 Jul;30(5):803-10. doi: 10.1016/j.jdiacomp.2016.03.020. Epub 2016 Mar 17. — View Citation

Jitraknatee J, Ruengorn C, Nochaiwong S. Prevalence and Risk Factors of Chronic Kidney Disease among Type 2 Diabetes Patients: A Cross-Sectional Study in Primary Care Practice. Sci Rep. 2020 Apr 10;10(1):6205. doi: 10.1038/s41598-020-63443-4. — View Citation

McMurray JJV, Solomon SD, Inzucchi SE, Køber L, Kosiborod MN, Martinez FA, Ponikowski P, Sabatine MS, Anand IS, Belohlávek J, Böhm M, Chiang CE, Chopra VK, de Boer RA, Desai AS, Diez M, Drozdz J, Dukát A, Ge J, Howlett JG, Katova T, Kitakaze M, Ljungman CEA, Merkely B, Nicolau JC, O'Meara E, Petrie MC, Vinh PN, Schou M, Tereshchenko S, Verma S, Held C, DeMets DL, Docherty KF, Jhund PS, Bengtsson O, Sjöstrand M, Langkilde AM; DAPA-HF Trial Committees and Investigators. Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction. N Engl J Med. 2019 Nov 21;381(21):1995-2008. doi: 10.1056/NEJMoa1911303. Epub 2019 Sep 19. — View Citation

Mok KY, Chan PF, Lai LKP, Chow KL, Chao DVK. Prevalence of diabetic nephropathy among Chinese patients with type 2 diabetes mellitus and different categories of their estimated glomerular filtration rate based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation in primary care in Hong Kong: a cross-sectional study. J Diabetes Metab Disord. 2019 Nov 15;18(2):281-288. doi: 10.1007/s40200-018-00382-y. eCollection 2019 Dec. — View Citation

Neal B, Perkovic V, Mahaffey KW, de Zeeuw D, Fulcher G, Erondu N, Shaw W, Law G, Desai M, Matthews DR; CANVAS Program Collaborative Group. Canagliflozin and Cardiovascular and Renal Events in Type 2 Diabetes. N Engl J Med. 2017 Aug 17;377(7):644-657. doi: 10.1056/NEJMoa1611925. Epub 2017 Jun 12. — View Citation

Perkovic V, Jardine MJ, Neal B, Bompoint S, Heerspink HJL, Charytan DM, Edwards R, Agarwal R, Bakris G, Bull S, Cannon CP, Capuano G, Chu PL, de Zeeuw D, Greene T, Levin A, Pollock C, Wheeler DC, Yavin Y, Zhang H, Zinman B, Meininger G, Brenner BM, Mahaffey KW; CREDENCE Trial Investigators. Canagliflozin and Renal Outcomes in Type 2 Diabetes and Nephropathy. N Engl J Med. 2019 Jun 13;380(24):2295-2306. doi: 10.1056/NEJMoa1811744. Epub 2019 Apr 14. — View Citation

Pollock C, Stefánsson B, Reyner D, Rossing P, Sjöström CD, Wheeler DC, Langkilde AM, Heerspink HJL. Albuminuria-lowering effect of dapagliflozin alone and in combination with saxagliptin and effect of dapagliflozin and saxagliptin on glycaemic control in patients with type 2 diabetes and chronic kidney disease (DELIGHT): a randomised, double-blind, placebo-controlled trial. Lancet Diabetes Endocrinol. 2019 Jun;7(6):429-441. doi: 10.1016/S2213-8587(19)30086-5. Epub 2019 Apr 13. — View Citation

Shikata K, Kodera R, Utsunomiya K, Koya D, Nishimura R, Miyamoto S, Tajima N; JDCP study group. Prevalence of albuminuria and renal dysfunction, and related clinical factors in Japanese patients with diabetes: The Japan Diabetes Complication and its Prevention prospective study 5. J Diabetes Investig. 2020 Mar;11(2):325-332. doi: 10.1111/jdi.13116. Epub 2019 Sep 25. — View Citation

Strojek K, Yoon KH, Hruba V, Elze M, Langkilde AM, Parikh S. Effect of dapagliflozin in patients with type 2 diabetes who have inadequate glycaemic control with glimepiride: a randomized, 24-week, double-blind, placebo-controlled trial. Diabetes Obes Metab. 2011 Oct;13(10):928-38. doi: 10.1111/j.1463-1326.2011.01434.x. — View Citation

Wen CP, Chang CH, Tsai MK, Lee JH, Lu PJ, Tsai SP, Wen C, Chen CH, Kao CW, Tsao CK, Wu X. Diabetes with early kidney involvement may shorten life expectancy by 16 years. Kidney Int. 2017 Aug;92(2):388-396. doi: 10.1016/j.kint.2017.01.030. Epub 2017 Jun 1. — View Citation

Wiviott SD, Raz I, Bonaca MP, Mosenzon O, Kato ET, Cahn A, Silverman MG, Zelniker TA, Kuder JF, Murphy SA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Ruff CT, Gause-Nilsson IAM, Fredriksson M, Johansson PA, Langkilde AM, Sabatine MS; DECLARE-TIMI 58 Investigators. Dapagliflozin and Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med. 2019 Jan 24;380(4):347-357. doi: 10.1056/NEJMoa1812389. Epub 2018 Nov 10. — View Citation

Zinman B, Wanner C, Lachin JM, Fitchett D, Bluhmki E, Hantel S, Mattheus M, Devins T, Johansen OE, Woerle HJ, Broedl UC, Inzucchi SE; EMPA-REG OUTCOME Investigators. Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. N Engl J Med. 2015 Nov 26;373(22):2117-28. doi: 10.1056/NEJMoa1504720. Epub 2015 Sep 17. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	MD of the Percentage change of HbA1c	the mean difference of the Percentage change from baseline of HbA1c between SGLT2i group and non-SGLT2i group	at 6 months
Other	MD the Percentage change from baseline of other laboratory test parameters of interest	the mean difference of the Percentage change from baseline of other laboratory test parameters of interest in SGLT2i group and non-SGLT2i group	at 6 months
Primary	Prevalence of DKD	Prevalence of DKD (UACR > 30 mg/g); The prevalence of microalbuminuria (30 mg/g = UACR = 300 mg/g); The prevalence of massive proteinuria (UACR > 300 mg/g).	at the time of screening
Primary	Awareness rate	Awareness rate=(The number of people who know their abnormal albuminuria)/(The number of people with diabetes mellitus complicated with albuminuria)	at the time of screening
Primary	Screening rate	Screening rate=(The number of people @who have checked urine protein within one year)/(The number of people involved in total diabetes)	at the time of screening
Primary	Prescription proportion of various anti-diabetic drugs for patients with DKD	Prescription ratio of a certain hypoglycemic agent =(The number of people using a certain hypoglycemic agent)/(Total number of DKD)	at the time of screening
Primary	risk factors of albuminuria: medication categories	Assess whether taking different categories of medications is a risk factor for albuminuria	at the time of screening
Primary	risk factors of albuminuria: Course of disease	It is defined as the years of diagnosis of diabetes. According to the "Date of Diagnosis" in the questionnaire collected during the screening, the course years of diabetes patients are divided into quartiles for evaluation	at the time of screening
Primary	risk factors of albuminuria: Age	According to the "date of birth" in the questionnaire collected during the screening, the age of diabetic patients is divided into quartiles for evaluation	at the time of screening
Primary	risk factors of albuminuria: Current smoking	According to the "Current smoking" in the questionnaire collected during the screening to evaluate whether smoking is the risk of albuminuria	at the time of screening
Primary	risk factors of albuminuria: gender	According to the "gender" in the questionnaire collected during the screening to evaluate whether gender is the risk of albuminuria	at the time of screening
Primary	risk factors of albuminuria: Drinking	According to the " Drinking " in the questionnaire collected during the screening to evaluate whether Drinking is the risk of albuminuria	at the time of screening
Primary	risk factors of albuminuria: Glycosylated hemoglobin	Baseline glycosylated hemoglobin is divided into quartiles for evaluation	at baseline
Primary	risk factors of albuminuria: Hypertension	It is defined as the adults' systolic blood pressure which is greater than or equal to 140mmHg and/or diastolic blood pressure which is greater than or equal to 90mmHg. "hypertension" and "non-hypertension" for evaluation	at baseline
Primary	risk factors of albuminuria: Increase in Low density lipoprotein cholesterol (LDL-C)	It is defined as more than 3.37mmol/L, "elevated" and "normal" for evaluation	at baseline
Secondary	MD of the change of UACR	the mean difference of the change of UACR from baseline between SGLT2i and non-SGLT2i group	at 6 months
Secondary	OR of the incidence of the adverse events	the odds ratio of the incidence of the adverse events of interest during the 6-month observation period between SGLT2i and non-SGLT2i group	at 6 months

External Links

•   Guideline for the prevention and treatment of type 2 diabetes mellitus in China (2020 edition)
•   Standards of Medical Care in Diabetes-2021. Diabetes Care.