Clinical trial NCT03064841: Clinical Characteristics, Anti-hyperglycaemic Treatment Pattern and Target Attainment of Type 2 Diabetes Mellitus Patients in Older Population With or Without Albuminuria in China
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2017-02-27
Enrollment: 1537
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Approximately 1500 patients will be recruited with Type 2 Diabetes Mellitus consecutively from departments of endocrinology from at least 30 hospitals of China.

Brief 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


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: At study visit (one day)
Secondary outcomes:
measure: Renal Function Level of Patients Measured by Albuminuria
timeFrame: At study visit (one day)
measure: Renal Function Level of Patients Measured by Estimated Glomerular Filtration Rate (eGFR)
timeFrame: At study visit (one day)
measure: Renal Function Level of Patients Measured by Chronic Kidney Disease (CKD) Stage
timeFrame: At study visit (one day)
measure: Treatment Regimens for T2DM That Patient Are Currently Taking
timeFrame: At study visit (one day)
measure: Percentage of Patients Macro-vascular and Micro-vascular Diabetic Complications
timeFrame: At study visit (one day)
measure: Percentage of Patients With Hypoglycaemic Occurrence
timeFrame: At study visit (one day)
measure: Percentage of Patients With Hypoglycaemia Leading to Therapy Change
timeFrame: At study visit (one day)
measure: Percentage of Patients With Anti-hypertension Therapy Usage
timeFrame: At study visit (one day)
measure: Percentage of Patients With Lipid Lowering Therapy Usage
timeFrame: At study visit (one day)
measure: Percentage of Patients With Anti-platelet Therapy Usage
timeFrame: At study visit (one day)
measure: Follow up Duration of Type 2 Diabetes Related Risk Factors in Clinical Practice
timeFrame: At study visit (one day)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Shougang Hospital
city: Beijing
country: China
facility: Beijing Hospital
city: Beijing
country: China
facility: Beijing Pinggu Hospital
city: Beijing
country: China
facility: China Meitan General Hospital
city: Changchun
country: China
facility: First Hospital of Jilin University
city: Chengdu
country: China
facility: Chinese Traditional Medicine Hospital of Sichuna Provinc
city: Chengdu
country: China
facility: West China Hospital
city: Dalian
country: China
facility: First Affiliated Hospital of Dalian Medical University
city: Harbin
country: China
facility: Forth Clinical Hospital of Harbin Medical University
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University
city: Luoyang
country: China
facility: The First Affiliated Hospital of Henan University of Science and Technology
city: Nanjing
country: China
facility: Nanjing First Hospital
city: Nanjing
country: China
facility: Integrated Chinese and Western Medicine Hospital
city: Nantong
country: China
facility: Affiliated Hospital of Nantong University
city: Qingdao
country: China
facility: The affiliated hospital of medicalcollege qingdao university
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: