Clinical Characteristics, Anti-hyperglycaemic Treatment Pattern and Target Attainment of Type 2 Diabetes Mellitus Patients in Older Population With or Without Albuminuria in China

An observational study of Type 2 Diabetes Mellitus, run by Boehringer Ingelheim at 18 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 60 years and older
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: No Treatment
How many people: 1,537 participants
Where: 18 sitesChina
Study dates: 9 Mar 2017to 30 Dec 2017
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 60 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Approximately 1500 patients will be recruited with Type 2 Diabetes Mellitus consecutively from departments of endocrinology from at least 30 hospitals of China.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

18 sites in 1 country.

City, postcode or hospital

18 sites in 1 country

China18 sites

Peking University Shougang Hospital
Beijing, 100043
Beijing Hospital
Beijing
Beijing Pinggu Hospital
Beijing
China Meitan General Hospital
Beijing
First Hospital of Jilin University
Changchun
Chinese Traditional Medicine Hospital of Sichuna Provinc
Chengdu, 610000
West China Hospital
Chengdu, 610041
First Affiliated Hospital of Dalian Medical University
Dalian, 116011
Forth Clinical Hospital of Harbin Medical University
Harbin
The First Affiliated Hospital of Anhui Medical University
Hefei, 230022
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang
Nanjing First Hospital
Nanjing, 210006
Integrated Chinese and Western Medicine Hospital
Nanjing, 210029
Affiliated Hospital of Nantong University
Nantong
The affiliated hospital of medicalcollege qingdao university
Qingdao, 266005
Shengjing Hospital of China Medical University
Shenyang, 110072
Shenzhen People's Hospital
Shenzhen, 518020
The First Affiliated Hospital of Soochow University
Suzhou, 215006

Other trials in China

About this study

Official 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

Conditions: Type 2 Diabetes Mellitus
Being tested: No Treatment
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

No TreatmentDrug
No treatment

Study groups in NCT03064841
Study group	Role	What they receive
Outpatient with confirmed T2DM		subjects with confirmed T2DM Receives: Drug: No Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: At study visit (one day)

Secondary outcomes (11)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Mar 201730 Dec 2017

First posted27 Feb 2017
Study start9 Mar 2017
Primary completion30 Dec 2017
Study completion30 Dec 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Cross-sectional
Enrolment: 1,537 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03064841
Sponsor's protocol ID: 1218.174
Status last verified: Jul 2019
First submitted: 22 Feb 2017
Last updated: 28 Aug 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
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All Type 2 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT03064841
Acronym / sponsor ID: 1218.174
Conditions: Type 2 Diabetes Mellitus
Study type: Observational
Recruitment status: Completed
Enrolment: 1,537 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 9 Mar 2017 (actual)
Primary completion: 30 Dec 2017 (actual)
Study completion: 30 Dec 2017 (actual)
First posted: 27 Feb 2017 (actual)
Results: Posted 28 Aug 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Cross-sectional
Number of arms: 1

Arm	Type	Receives
Outpatient with confirmed T2DM	–	Drug: No Treatmentsubjects with confirmed T2DM

Who may qualify

Ages: 60 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Approximately 1500 patients will be recruited with Type 2 Diabetes Mellitus consecutively from departments of endocrinology from at least 30 hospitals of China.

Key inclusion criteria (3 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
No TreatmentNo treatment	Drug	Outpatient with confirmed T2DM

Primary outcome

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.

11 secondary outcomes

Renal Function Level of Patients Measured by Albuminuria
Time frame: At study visit (one day)
Renal Function Level of Patients Measured by Estimated Glomerular Filtration Rate (eGFR)
Time frame: At study visit (one day)
Renal Function Level of Patients Measured by Chronic Kidney Disease (CKD) Stage
Time frame: At study visit (one day)
Treatment Regimens for T2DM That Patient Are Currently Taking
Time frame: At study visit (one day)
Percentage of Patients Macro-vascular and Micro-vascular Diabetic Complications
Time frame: At study visit (one day)
Percentage of Patients With Hypoglycaemic Occurrence
Time frame: At study visit (one day)
Percentage of Patients With Hypoglycaemia Leading to Therapy Change
Time frame: At study visit (one day)
Percentage of Patients With Anti-hypertension Therapy Usage
Time frame: At study visit (one day)
Percentage of Patients With Lipid Lowering Therapy Usage
Time frame: At study visit (one day)
Percentage of Patients With Anti-platelet Therapy Usage
Time frame: At study visit (one day)
Follow up Duration of Type 2 Diabetes Related Risk Factors in Clinical Practice
Time frame: At study visit (one day)

Results and safety

Results posted to the registry on 28 Aug 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)	1,537	1,520

Primary outcome: 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). Number. Unit: Percentage of patients

Measure	Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM) n = 1520
Value	43.4

Population analysed: Full Analysis Set - Eligible (FAS - E): The FAS - E includes all eligible patients regarding to inclusion and exclusion criteria with an glycated haemoglobin A1c (HbA1c) measurement.

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: From signing the informed consent until completed the visit that day i.e., up to 24hrs.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)	0 of 1,520 (0%)	0 of 1,520 (0%)	0 of 1,520

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

Related trials for Type 2 Diabetes Mellitus

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

18 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Type 2 Diabetes Mellitus, run by Boehringer Ingelheim at 18 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03064841.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.