Clinical Characteristics, Anti-hyperglycaemic Treatment Pattern and Target Attainment of Type 2 Diabetes Mellitus Patients in Older Population With or Without Albuminuria in China
CompletedResults postedLast updated 28 August 2019
What this trial tests
trial testing No Treatment in Type 2 Diabetes Mellitus in 1,537 participants. Completed in 30 December 2017.
60 and older, any sex, with Type 2 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.Primary· 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.
Group
Value
95% CI
Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)
43.4
Renal Function Level of Patients Measured by AlbuminuriaSecondary· 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 s
Normal
Group
Value
95% CI
Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)
63.8
Micro-albuminuria
Group
Value
95% CI
Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)
27.6
Macro-albuminuria
Group
Value
95% CI
Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)
7.1
Missing
Group
Value
95% CI
Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)
1.5
Renal Function Level of Patients Measured by Estimated Glomerular Filtration Rate (eGFR)Secondary· At study visit (one day)
The renal function level of patients was measured by estimated glomerular filtration rate (eGFR).
Group
Value
95% CI
Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)
85.019
± 18.204
Renal Function Level of Patients Measured by Chronic Kidney Disease (CKD) StageSecondary· 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.
eGFR >=60 mL/min/1.73m^2
Group
Value
95% CI
Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)
51.1
eGFR < 60 mL/min/1.73m^2
Group
Value
95% CI
Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)
5.4
Missing eGFR data
Group
Value
95% CI
Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)
43.6
Treatment Regimens for T2DM That Patient Are Currently TakingSecondary· At study visit (one day)
The treatment regimens for T2DM that patient are currently taking.
No treatment
Group
Value
95% CI
Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)
2.6
Only diet control and exercise
Group
Value
95% CI
Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)
7.5
Oral antidiabetic drug (OAD) - Mono therapy
Group
Value
95% CI
Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)
16.8
OAD - Combined therapy
Group
Value
95% CI
Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)
28.7
Insulin only
Group
Value
95% CI
Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)
15.5
OAD and Insulin
Group
Value
95% CI
Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)
28.3
Missing
Group
Value
95% CI
Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)
0.6
Percentage of Patients Macro-vascular and Micro-vascular Diabetic ComplicationsSecondary· At study visit (one day)
The percentage of patients macro-vascular and micro-vascular diabetic complications.
Cardiovascular disease
Group
Value
95% CI
Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)
14.9
Cerebrovascular disease
Group
Value
95% CI
Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)
11.2
Peripheral vascular disease
Group
Value
95% CI
Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)
8.8
Kidney disease
Group
Value
95% CI
Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)
8.6
Retinopathy
Group
Value
95% CI
Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)
14.4
Neuropathy
Group
Value
95% CI
Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)
13.6
Percentage of Patients With Hypoglycaemic OccurrenceSecondary· At study visit (one day)
The percentage of patients with hypoglycaemic occurrence.
Group
Value
95% CI
Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)
28.0
Percentage of Patients With Hypoglycaemia Leading to Therapy ChangeSecondary· At study visit (one day)
The percentage of patients with hypoglycaemia leading to therapy change.
Group
Value
95% CI
Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)
7.2
Percentage of Patients With Anti-hypertension Therapy UsageSecondary· At study visit (one day)
The percentage of patients with anti-hypertension therapy usage.
Group
Value
95% CI
Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)
49.0
Percentage of Patients With Lipid Lowering Therapy UsageSecondary· At study visit (one day)
The percentage of patients with lipid lowering therapy usage.
Group
Value
95% CI
Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)
29.2
Percentage of Patients With Anti-platelet Therapy UsageSecondary· At study visit (one day)
The percentage of patients with anti-platelet therapy usage.
Group
Value
95% CI
Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)
30.1
Follow up Duration of Type 2 Diabetes Related Risk Factors in Clinical PracticeSecondary· 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.
Follow-up duration - within 3 months
Group
Value
95% CI
Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)
33.6
Follow-up duration - within 3 to 6 months
Group
Value
95% CI
Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)
16.1
Follow-up duration - within 6 to 12 months
Group
Value
95% CI
Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)
17.3
Follow-up duration - More than 12 months
Group
Value
95% CI
Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)
27.8
Missing follow-up duration
Group
Value
95% CI
Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)
5.3
Sponsor's own description
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
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 28 August 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03064841.