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NCT Number: 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

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

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Hospital, Beijing, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

no treatment

Drug

No treatment

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.

    Time frame: 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 outcomes

  1. Renal Function Level of Patients Measured by Albuminuria

    Time frame: 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.

  2. Renal Function Level of Patients Measured by Estimated Glomerular Filtration Rate (eGFR)

    Time frame: At study visit (one day)

    The renal function level of patients was measured by estimated glomerular filtration rate (eGFR).

  3. Renal Function Level of Patients Measured by Chronic Kidney Disease (CKD) Stage

    Time frame: 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.

  4. Treatment Regimens for T2DM That Patient Are Currently Taking

    Time frame: At study visit (one day)

    The treatment regimens for T2DM that patient are currently taking.

  5. Percentage of Patients Macro-vascular and Micro-vascular Diabetic Complications

    Time frame: At study visit (one day)

    The percentage of patients macro-vascular and micro-vascular diabetic complications.

  6. Percentage of Patients With Hypoglycaemic Occurrence

    Time frame: At study visit (one day)

    The percentage of patients with hypoglycaemic occurrence.

  7. Percentage of Patients With Hypoglycaemia Leading to Therapy Change

    Time frame: At study visit (one day)

    The percentage of patients with hypoglycaemia leading to therapy change.

  8. Percentage of Patients With Anti-hypertension Therapy Usage

    Time frame: At study visit (one day)

    The percentage of patients with anti-hypertension therapy usage.

  9. Percentage of Patients With Lipid Lowering Therapy Usage

    Time frame: At study visit (one day)

    The percentage of patients with lipid lowering therapy usage.

  10. Percentage of Patients With Anti-platelet Therapy Usage

    Time frame: At study visit (one day)

    The percentage of patients with anti-platelet therapy usage.

  11. Follow up Duration of Type 2 Diabetes Related Risk Factors in Clinical Practice

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Feb 27, 2017
Registry last updated
Aug 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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