Clinical Characteristics, Anti-hyperglycaemic Treatment Pattern and Target Attainment of Type 2 Diabetes Mellitus Patients in Older Population With or Without Albuminuria in China
1 other identifier
observational
1,537
1 country
18
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2017
Shorter than P25 for all trials
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 22, 2017
CompletedFirst Posted
Study publicly available on registry
February 27, 2017
CompletedStudy Start
First participant enrolled
March 9, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2017
CompletedResults Posted
Study results publicly available
August 28, 2019
CompletedAugust 28, 2019
July 1, 2019
10 months
February 22, 2017
December 19, 2018
July 19, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (11)
Renal Function Level of Patients Measured by Albuminuria
At study visit (one day)
Renal Function Level of Patients Measured by Estimated Glomerular Filtration Rate (eGFR)
At study visit (one day)
Renal Function Level of Patients Measured by Chronic Kidney Disease (CKD) Stage
At study visit (one day)
Treatment Regimens for T2DM That Patient Are Currently Taking
At study visit (one day)
Percentage of Patients Macro-vascular and Micro-vascular Diabetic Complications
At study visit (one day)
- +6 more secondary outcomes
Study Arms (1)
Outpatient with confirmed T2DM
subjects with confirmed T2DM
Interventions
Eligibility Criteria
Approximately 1500 patients will be recruited with Type 2 Diabetes Mellitus consecutively from departments of endocrinology from at least 30 hospitals of China.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Peking University Shougang Hospital
Beijing, 100043, China
Beijing Hospital
Beijing, China
Beijing Pinggu Hospital
Beijing, China
China Meitan General Hospital
Beijing, China
First Hospital of Jilin University
Changchun, China
Chinese Traditional Medicine Hospital of Sichuna Provinc
Chengdu, 610000, China
West China Hospital
Chengdu, 610041, China
First Affiliated Hospital of Dalian Medical University
Dalian, 116011, China
Forth Clinical Hospital of Harbin Medical University
Harbin, China
The First Affiliated Hospital of Anhui Medical University
Hefei, 230022, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, China
Nanjing First Hospital
Nanjing, 210006, China
Integrated Chinese and Western Medicine Hospital
Nanjing, 210029, China
Affiliated Hospital of Nantong University
Nantong, China
The affiliated hospital of medicalcollege qingdao university
Qingdao, 266005, China
Shengjing Hospital of China Medical University
Shenyang, 110072, China
Shenzhen People's Hospital
Shenzhen, 518020, China
The First Affiliated Hospital of Soochow University
Suzhou, 215006, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Boehringer Ingelheim Call Centre
- Organization
- Boehringer Ingelheim
Study Officials
- STUDY CHAIR
Boehringer Ingelheim
Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 22, 2017
First Posted
February 27, 2017
Study Start
March 9, 2017
Primary Completion
December 30, 2017
Study Completion
December 30, 2017
Last Updated
August 28, 2019
Results First Posted
August 28, 2019
Record last verified: 2019-07