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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

Completed Results posted Last 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.

Timeline
9 March 2017
Primary endpoint
30 December 2017
30 December 2017

Quick facts

Lead sponsorBoehringer Ingelheim
StatusCompleted
Study typeOBSERVATIONAL
Enrollment1,537
Start date9 March 2017
Primary completion30 December 2017
Estimated completion30 December 2017
Sites18 locations across China

Drugs / interventions tested

Conditions studied

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

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.

GroupValue95% CI
Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)43.4
Renal Function Level of Patients Measured by Albuminuria Secondary · 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
GroupValue95% CI
Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)63.8
Micro-albuminuria
GroupValue95% CI
Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)27.6
Macro-albuminuria
GroupValue95% CI
Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)7.1
Missing
GroupValue95% 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).

GroupValue95% CI
Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)85.019± 18.204
Renal Function Level of Patients Measured by Chronic Kidney Disease (CKD) Stage Secondary · 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
GroupValue95% CI
Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)51.1
eGFR < 60 mL/min/1.73m^2
GroupValue95% CI
Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)5.4
Missing eGFR data
GroupValue95% CI
Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)43.6
Treatment Regimens for T2DM That Patient Are Currently Taking Secondary · At study visit (one day)

The treatment regimens for T2DM that patient are currently taking.

No treatment
GroupValue95% CI
Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)2.6
Only diet control and exercise
GroupValue95% CI
Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)7.5
Oral antidiabetic drug (OAD) - Mono therapy
GroupValue95% CI
Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)16.8
OAD - Combined therapy
GroupValue95% CI
Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)28.7
Insulin only
GroupValue95% CI
Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)15.5
OAD and Insulin
GroupValue95% CI
Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)28.3
Missing
GroupValue95% CI
Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)0.6
Percentage of Patients Macro-vascular and Micro-vascular Diabetic Complications Secondary · At study visit (one day)

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

Cardiovascular disease
GroupValue95% CI
Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)14.9
Cerebrovascular disease
GroupValue95% CI
Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)11.2
Peripheral vascular disease
GroupValue95% CI
Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)8.8
Kidney disease
GroupValue95% CI
Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)8.6
Retinopathy
GroupValue95% CI
Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)14.4
Neuropathy
GroupValue95% CI
Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)13.6
Percentage of Patients With Hypoglycaemic Occurrence Secondary · At study visit (one day)

The percentage of patients with hypoglycaemic occurrence.

GroupValue95% CI
Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)28.0
Percentage of Patients With Hypoglycaemia Leading to Therapy Change Secondary · At study visit (one day)

The percentage of patients with hypoglycaemia leading to therapy change.

GroupValue95% CI
Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)7.2
Percentage of Patients With Anti-hypertension Therapy Usage Secondary · At study visit (one day)

The percentage of patients with anti-hypertension therapy usage.

GroupValue95% CI
Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)49.0
Percentage of Patients With Lipid Lowering Therapy Usage Secondary · At study visit (one day)

The percentage of patients with lipid lowering therapy usage.

GroupValue95% CI
Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)29.2
Percentage of Patients With Anti-platelet Therapy Usage Secondary · At study visit (one day)

The percentage of patients with anti-platelet therapy usage.

GroupValue95% CI
Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)30.1
Follow up Duration of Type 2 Diabetes Related Risk Factors in Clinical Practice Secondary · 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
GroupValue95% CI
Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)33.6
Follow-up duration - within 3 to 6 months
GroupValue95% CI
Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)16.1
Follow-up duration - within 6 to 12 months
GroupValue95% CI
Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)17.3
Follow-up duration - More than 12 months
GroupValue95% CI
Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)27.8
Missing follow-up duration
GroupValue95% 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.

Verify or expand the search:

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Trials testing the same drug.

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Trials by the same sponsor.

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Data sources for this page

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.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing