N/A
N=1,537
Clinical Characteristics, Anti-hyperglycaemic Treatment Pattern and Target Attainment of Type 2 Diabetes Mellitus Patients in Older Population With or Without Albuminuria in China
Type 2 Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT03064841 ↗Enrolled (actual)
1,537
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcome: 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. — 43.4 Percentage of patients
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- No Treatment (Drug)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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. |
43.4 | — |
| SECONDARY Renal Function Level of Patients Measured by Albuminuria |
63.8; 27.6; 7.1; 1.5 | — |
| SECONDARY Renal Function Level of Patients Measured by Estimated Glomerular Filtration Rate (eGFR) |
85.019 | — |
| SECONDARY Renal Function Level of Patients Measured by Chronic Kidney Disease (CKD) Stage |
51.1; 5.4; 43.6 | — |
| SECONDARY Treatment Regimens for T2DM That Patient Are Currently Taking |
2.6; 7.5; 16.8; 28.7; 15.5; 28.3 | — |
| SECONDARY Percentage of Patients Macro-vascular and Micro-vascular Diabetic Complications |
14.9; 11.2; 8.8; 8.6; 14.4; 13.6 | — |
| SECONDARY Percentage of Patients With Hypoglycaemic Occurrence |
28.0 | — |
| SECONDARY Percentage of Patients With Hypoglycaemia Leading to Therapy Change |
7.2 | — |
| SECONDARY Percentage of Patients With Anti-hypertension Therapy Usage |
49.0 | — |
| SECONDARY Percentage of Patients With Lipid Lowering Therapy Usage |
29.2 | — |
| SECONDARY Percentage of Patients With Anti-platelet Therapy Usage |
30.1 | — |
| SECONDARY Follow up Duration of Type 2 Diabetes Related Risk Factors in Clinical Practice |
33.6; 16.1; 17.3; 27.8; 5.3 | — |
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
Data sourced from ClinicalTrials.gov (NCT03064841). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.