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

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

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

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: No Treatment

• Study Type: Observational
• Enrollment (Actual): 1537

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Beijing Hospital
  • Beijing, China
    • Beijing Pinggu Hospital
  • Beijing, China, 100043
    • Peking University Shougang Hospital
  • Beijing, China
    • China Meitan General Hospital
  • Changchun, China
    • First Hospital of Jilin University
  • Chengdu, China, 610041
    • West China Hospital
  • Chengdu, China, 610000
    • Chinese Traditional Medicine Hospital of Sichuna Provinc
  • Dalian, China, 116011
    • First Affiliated Hospital of Dalian Medical University
  • Harbin, China
    • Forth Clinical Hospital of Harbin Medical University
  • Hefei, China, 230022
    • The First affiliated Hospital of Anhui Medical University
  • Luoyang, China
    • The First Affiliated Hospital of Henan University of Science and Technology
  • Nanjing, China, 210006
    • Nanjing First Hospital
  • Nanjing, China, 210029
    • Integrated Chinese and Western Medicine Hospital
  • Nantong, China
    • Affiliated Hospital of Nantong University
  • Qingdao, China, 266005
    • The affiliated hospital of medicalcollege qingdao university
  • Shenyang, China, 110072
    • Shengjing Hospital of China Medical University
  • Shenzhen, China, 518020
    • ShenZhen People's Hospital
  • Suzhou, China, 215006
    • The First Affiliated Hospital of Soochow University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Outpatient with confirmed T2DM; subjects with confirmed T2DM	Drug: No Treatment; No treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
Treatment Regimens for T2DM That Patient Are Currently Taking	The treatment regimens for T2DM that patient are currently taking.	At study visit (one day)
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)
Percentage of Patients With Hypoglycaemic Occurrence	The percentage of patients with hypoglycaemic occurrence.	At study visit (one day)
Percentage of Patients With Hypoglycaemia Leading to Therapy Change	The percentage of patients with hypoglycaemia leading to therapy change.	At study visit (one day)
Percentage of Patients With Anti-hypertension Therapy Usage	The percentage of patients with anti-hypertension therapy usage.	At study visit (one day)
Percentage of Patients With Lipid Lowering Therapy Usage	The percentage of patients with lipid lowering therapy usage.	At study visit (one day)
Percentage of Patients With Anti-platelet Therapy Usage	The percentage of patients with anti-platelet therapy usage.	At study visit (one day)
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)

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 9, 2017
• Primary Completion (ACTUAL): December 30, 2017
• Study Completion (ACTUAL): December 30, 2017

Study Registration Dates

• First Submitted: February 22, 2017
• First Submitted That Met QC Criteria: February 22, 2017
• First Posted (ACTUAL): February 27, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 28, 2019
• Last Update Submitted That Met QC Criteria: July 19, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Urologic Diseases; Urological Manifestations; Endocrine System Diseases; Urination Disorders; Proteinuria; Diabetes Mellitus; Diabetes Mellitus, Type 2; Albuminuria
• Other Study ID Numbers: 1218.174

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes