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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03064841

Enrollment

1537

Registered

2017-02-27

Start date

2017-03-09

Completion date

2017-12-30

Last updated

2019-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

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

Interventions

DRUGNo Treatment

No treatment

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

60 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.	At study visit (one day)	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.

Secondary

Measure	Time frame	Description
Renal Function Level of Patients Measured by Estimated Glomerular Filtration Rate (eGFR)	At study visit (one day)	The renal function level of patients was measured by estimated glomerular filtration rate (eGFR).
Renal Function Level of Patients Measured by Chronic Kidney Disease (CKD) Stage	At study visit (one day)	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.
Treatment Regimens for T2DM That Patient Are Currently Taking	At study visit (one day)	The treatment regimens for T2DM that patient are currently taking.
Percentage of Patients Macro-vascular and Micro-vascular Diabetic Complications	At study visit (one day)	The percentage of patients macro-vascular and micro-vascular diabetic complications.
Percentage of Patients With Hypoglycaemic Occurrence	At study visit (one day)	The percentage of patients with hypoglycaemic occurrence.
Renal Function Level of Patients Measured by Albuminuria	At study visit (one day)	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.
Percentage of Patients With Anti-hypertension Therapy Usage	At study visit (one day)	The percentage of patients with anti-hypertension therapy usage.
Percentage of Patients With Lipid Lowering Therapy Usage	At study visit (one day)	The percentage of patients with lipid lowering therapy usage.
Percentage of Patients With Anti-platelet Therapy Usage	At study visit (one day)	The percentage of patients with anti-platelet therapy usage.
Follow up Duration of Type 2 Diabetes Related Risk Factors in Clinical Practice	At study visit (one day)	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.
Percentage of Patients With Hypoglycaemia Leading to Therapy Change	At study visit (one day)	The percentage of patients with hypoglycaemia leading to therapy change.

Countries

China

Participant flow

Recruitment details

Patients were recruited into the study in the order of their clinical visits scheduled. First 7 consented and suitable patients were recruited for each site on each day, or fewer if without enough patients. One study visit was planned for each patient.The data was collected for this study from 09th March, 2017 to 30th December, 2017.

Pre-assignment details

All subjects were screened for eligibility to participate in trial. Subjects attended specialist sites to ensure that they (the subjects) met all implemented inclusion/exclusion criteria. Subjects were not to be included in the study if any of specific entry criteria was violated.

Participants by arm

Arm	Count
Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM) Outpatients with confirmed type 2 diabetes mellitus (T2DM), whose treatments patterns included only diet control and exercise; oral antidiabetic drug (OAD)-mono therapy; OAD-combined therapy; insulin only; OAD and insulin both.	1,520
Total	1,520

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Inclusion/exclusion criteria violation	4
Overall Study	No glycated haemoglobinA1c measurement	11
Overall Study	Screen failure	2

Baseline characteristics

Characteristic	Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)	—
Age, Continuous	67.7 Years STANDARD_DEVIATION 5.86	—
Race and Ethnicity Not Collected	—	— Participants
Sex: Female, Male Female	819 Participants	—
Sex: Female, Male Male	701 Participants	—

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 1,520
other Total, other adverse events	0 / 1,520
serious Total, serious adverse events	0 / 1,520

Outcome results

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.