Clinical Characteristics, Anti-hyperglycaemic Treatment Pattern and Target Attainment of Type 2 Diabetes Mellitus Patients in Older Population With or Without Albuminuria in China

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Clinical Characteristics, Anti-hyperglycaemic Treatment Pattern and Target Attainment of Type 2 Diabetes Mellitus Patients in Older Population With or Without Albuminuria in China: A Nationwide Cross-sectional Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03064841
• Other study ID #: 1218.174
• Status: Completed
• Start date: March 9, 2017
• Est. completion date: December 30, 2017

Study information

• Verified date: July 2019
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a multi-centre, cross-sectional, non-interventional study assessing blood glucose target attainment, anti-hyperglycaemic treatment pattern and the clinical characteristics in older outpatients with Type 2 Diabetes Mellitus (T2DM) in hospitals of China. This study is designed to collect information of older T2DM patients in a real life setting

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1537
• Est. completion date: December 30, 2017
• Est. primary completion date: December 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion criteria

• Patient should fully know and understand the content of consent form, and the patient is willing and able to sign an informed consent form

• Outpatient with confirmed T2DM (According to the American Diabetes Association criteria 2015 [R16-1532])

• Age=60 years

Exclusion criteria

• Patients with type 1 diabetes mellitus or secondary DM

• Patients who are participating in any other clinical study, including any questionnaire-based study, any interventional study (including diet/counselling based intervention), or any clinical study in which any medications (including Chinese herbal medications) are administered

Related Conditions & MeSH terms

• Albuminuria
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• No Treatment
No treatment

Locations

Country	Name	City	State
China	Beijing Hospital	Beijing
China	Beijing Pinggu Hospital	Beijing
China	China Meitan General Hospital	Beijing
China	Peking University Shougang Hospital	Beijing
China	First Hospital of Jilin University	Changchun
China	Chinese Traditional Medicine Hospital of Sichuna Provinc	Chengdu
China	West China Hospital	Chengdu
China	First Affiliated Hospital of Dalian Medical University	Dalian
China	Forth Clinical Hospital of Harbin Medical University	Harbin
China	The First Affiliated Hospital of Anhui Medical University	Hefei
China	The First Affiliated Hospital of Henan University of Science and Technology	Luoyang
China	Integrated Chinese and Western Medicine Hospital	Nanjing
China	Nanjing First Hospital	Nanjing
China	Affiliated Hospital of Nantong University	Nantong
China	The affiliated hospital of medicalcollege qingdao university	Qingdao
China	Shengjing Hospital of China Medical University	Shenyang
China	Shenzhen People's Hospital	Shenzhen
China	The First Affiliated Hospital of Soochow University	Suzhou

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Patients Attained Blood Glucose Control Target Defined as Glycated Haemoglobin A1c (HbA1c)<7%, According to 2015 American Diabetes Association (ADA) and 2013 Chinese Diabetes Society (CDS) Guidelines.	The percentage of patients attaining blood glucose control target defined as HbA1c<7%, according to 2015 American Diabetes Association (ADA) and 2013 Chinese Diabetes Society (CDS) guidelines.	At study visit (one day)
Secondary	Renal Function Level of Patients Measured by Albuminuria	The renal function level of patients was measured by albuminuria into following categories - normal, micro-albuminuria, macro-albuminuria and missing data.; Albuminuria was measured using either as a random spot urine sample, a 24-h urine sample, or a timed urine sample. Normal was defined as < 30 mg/g, <30 mg/24h, and < 20 µg/min with the random spot urine sample, the 24-h urine sample, and the timed urine sample, respectively. Micro-albuminuria was defined as 30 - 300 mg/g, 30 - 300 mg/24h, and 20 - 200 µg/min with the random spot urine sample, the 24-h urine sample, and the timed urine sample, respectively. Macro-albuminuria was defined as >300 mg/g, >300 mg/24h, and >200 µg/min with the random spot urine sample, the 24-h urine sample, and the timed urine sample, respectively.	At study visit (one day)
Secondary	Renal Function Level of Patients Measured by Estimated Glomerular Filtration Rate (eGFR)	The renal function level of patients was measured by estimated glomerular filtration rate (eGFR).	At study visit (one day)
Secondary	Renal Function Level of Patients Measured by Chronic Kidney Disease (CKD) Stage	The renal function level of patients was measured by CKD into following categories - eGFR = 60 milliLitre/minute/1.73 meter ^ 2 (mL/min/1.73m^2), eGFR < 60 mL/min/1.73m^2 and missing data.	At study visit (one day)
Secondary	Treatment Regimens for T2DM That Patient Are Currently Taking	The treatment regimens for T2DM that patient are currently taking.	At study visit (one day)
Secondary	Percentage of Patients Macro-vascular and Micro-vascular Diabetic Complications	The percentage of patients macro-vascular and micro-vascular diabetic complications.	At study visit (one day)
Secondary	Percentage of Patients With Hypoglycaemic Occurrence	The percentage of patients with hypoglycaemic occurrence.	At study visit (one day)
Secondary	Percentage of Patients With Hypoglycaemia Leading to Therapy Change	The percentage of patients with hypoglycaemia leading to therapy change.	At study visit (one day)
Secondary	Percentage of Patients With Anti-hypertension Therapy Usage	The percentage of patients with anti-hypertension therapy usage.	At study visit (one day)
Secondary	Percentage of Patients With Lipid Lowering Therapy Usage	The percentage of patients with lipid lowering therapy usage.	At study visit (one day)
Secondary	Percentage of Patients With Anti-platelet Therapy Usage	The percentage of patients with anti-platelet therapy usage.	At study visit (one day)
Secondary	Follow up Duration of Type 2 Diabetes Related Risk Factors in Clinical Practice	The follow up duration of type 2 diabetes related risk factors was summarized using the situation of lab test including serum creatinine, uric acid, high density lipoprotein cholesterol, low density lipoprotein cholesterol, triglyceride and total cholesterol.	At study visit (one day)

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