Type 2 Diabetes MellitusBM4DMNCT03477786
Blood Pressure Control for Type 2 Diabetes
A study testing drug adjustment and behavioral modification in people with Type 2 Diabetes Mellitus and Hypertension, run by National Health Research Institutes, Taiwan at 2 sites in Taiwan.
Trial summary
The BP4DM study was initiated as a prospective randomized controlled trial to investigate the renal protection effect for tight blood pressure control for Taiwanese T2DM patients without previously diagnosed CV events. We set our primary outcome for the prevention of microalbuminuria development. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Hypertension
- What is being tested?
- drug adjustment and behavioral modification
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,500 participants
- Where
- 2 sitesTaiwan
- Study dates
- 28 Oct 2013to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria (for both RCT trial and observational cohort study):
- type 2 DM with hypertension
Exclusion Criteria (for both RCT trial and observational cohort study):
- ACR>300 mg/g
- prior history of severe CV events (e.g., MI, stroke, heart failure>NYHA functional class III)
- dialysis, blindness, amputation, liver cirrhosis, cancer under active treatment
- pregnant women
- proteinuria which is unrelated with diabetes
- urinary tract stone > 0.5 cm
Stricter Exclusion Criteria (for RCT trial only):
- unstable BP (SBP>160 or DBP>100)
- unstable glycemic control (HbA1c>10%)
- K>5.0 meq/L
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites, 2 recruiting
- Recruiting
Kaohsiung Medical University Hospital
Kaohsiung City
Kun-Der Lin, PhD
- Recruiting
Min-Sheng General Hospital
Taoyuan
Chih-Cheng Hsu, 886-37-246166 ext. 36336, cch@nhri.org.tw
About this study
Official title: Blood Pressure Control to Reduce Renal Risk for Type 2 Diabetes Mellitus
The BP4DM study was initiated as a prospective randomized controlled trial to investigate the renal protection effect for tight blood pressure control for Taiwanese T2DM patients without previously diagnosed CV events. We set our primary outcome for the prevention of microalbuminuria development. The secondary outcomes include mortality, annual renal function declining rate, and development of cardiovascular events. The recruitment period for the RCT trial is from 2013 Oct to 2019 Dec. In addition, we also intend to continuously follow up all our recruited hypertensive diabetes patients for at least 10 years to observe their clinical outcomes including cardiovascular, renal, retinal outcomes and mortality.
Read the detailed description
The evidence from previous literature shows importance of the blood pressure control in T2DM. About 20% (16-29%) reduction in microalbuminuria development can be reached by continuously lowering blood pressure level from 154/87 mmHg to 144/82 mmHg (the UKPDS), to 134.7/74.8 mmHg (the ADVANCE study), and even to 119.3/64.4 mmHg (the ACCORD study). However, several limitations are also inherent in the above well-known studies. First, most of the recruited participants previous trials were Caucasians. Although 3293 Chinese patients were recruited in the ADVANCE study, they only accounted for 29.6% of total enrollees in that trial. The representative of Asian population is inadequate. There is also lack of domestic evidence-based guideline designated for Taiwanese T2DM patients in optimizing their blood pressure control. In addition, some characteristics in Asian T2DM population are different from what have been observed in the Caucasian T2DM patients. For example, there is BMI discrepancy between T2DM in Western and Eastern countries, more ACEi/ARB side effects (e.g., cough) observed in Asian population, and the possible difference in CKD/ESRD incidence in T2DM between different ethnic groups.
Moreover, the enrollees in most well-known trials (e.g., ADVANCE and ACCORD studies) were those who suffered from at least one cardiovascular risk factor for secondary prevention. To our best knowledge, there is no study designed to evaluate effectiveness of blood pressure control for T2DM patients without previous CV events. Therefore, we initiated a prospective randomized controlled trial to investigate the renal protection effect for tight blood pressure control for Taiwanese T2DM patients without previously diagnosed CV events. We set our primary outcome for the prevention of microalbuminuria development to partly respond to the urgent need for this society in solving the huge burden caused by the high incidence and prevalence of diabetic nephropathy in Taiwan.
The study includes two parts: (1) a RCT trial, (2) an observational cohort study. The recruitment period of this study is from 2013 Oct to 2019 Dec. The RCT trial will be ended in 2019 Dec. In addition, we also intend to continuously follow up all our recruited hypertensive diabetes patients for at least 10 years to observe their clinical outcomes including cardiovascular, renal, retinal outcomes and mortality (the part of the observational cohort study).
- Conditions
- Type 2 Diabetes Mellitus, Hypertension
- Being tested
- drug adjustment and behavioral modification
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
drug adjustment and behavioral modificationCombination product
anti-hypertension drug prescription by physician and case management by health educator
| Study group | Role | What they receive |
|---|---|---|
| tight BP | Active comparator | Interventions: anti-hypertension drug prescription by physician and case management by health educator.
Blood pressure is targeted at 120/80 mmHg in the tight BP control group. Receives: Combination Product: drug adjustment and behavioral modification |
| usual BP | Placebo comparator | Interventions: The physicians follow their usual care patterns to prescribe anti-HT drugs.
Blood pressure is targeted at < 140/90 mmHg in the usual BP control group. Receives: Combination Product: drug adjustment and behavioral modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
development of microalbuminuria
indicator of microalbuminuria: urine ACR
Measured: up to 10 years
Secondary outcomes (3)
mortality
all-cause mortality and CV-specific mortality
Measured: up to 10 years
annual renal function declining rate
indicator of renal function: eGFR assessed by CKD-EPI formula
Measured: up to 10 years
development of cardiovascular events
cardiovascular events include MI, heart failure, and stroke
Measured: up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2018
- Study start28 Oct 2013
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Health Research Institutes, Taiwan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chih-Cheng Hsu, DrPH, Principal investigator, National Health Research Institutes, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03477786
- Sponsor's protocol ID
- PH-107-PP-21
- Acronym
- BM4DM
- Status last verified
- Mar 2018
- First submitted
- 11 Mar 2018
- Last updated
- 26 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Pressure Control to Reduce Renal Risk for Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT03477786
- Acronym / sponsor ID
- BM4DM / PH-107-PP-21
- Conditions
- Type 2 Diabetes Mellitus, Hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- National Health Research Institutes, TaiwanUniversity, hospital or other
- Study start
- 28 Oct 2013 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 26 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The BP4DM study was initiated as a prospective randomized controlled trial to investigate the renal protection effect for tight blood pressure control for Taiwanese T2DM patients without previously diagnosed CV events. We set our primary outcome for the prevention of microalbuminuria development. The secondary outcomes include mortality, annual renal function declining rate, and development of cardiovascular events. The recruitment period for the RCT trial is from 2013 Oct to 2019 Dec. In addition, we also intend to continuously follow up all our recruited hypertensive diabetes patients for at least 10 years to observe their clinical outcomes including cardiovascular, renal, retinal outcomes and mortality.
Detailed description
The evidence from previous literature shows importance of the blood pressure control in T2DM. About 20% (16-29%) reduction in microalbuminuria development can be reached by continuously lowering blood pressure level from 154/87 mmHg to 144/82 mmHg (the UKPDS), to 134.7/74.8 mmHg (the ADVANCE study), and even to 119.3/64.4 mmHg (the ACCORD study). However, several limitations are also inherent in the above well-known studies. First, most of the recruited participants previous trials were Caucasians. Although 3293 Chinese patients were recruited in the ADVANCE study, they only accounted for 29.6% of total enrollees in that trial. The representative of Asian population is inadequate. There is also lack of domestic evidence-based guideline designated for Taiwanese T2DM patients in optimizing their blood pressure control. In addition, some characteristics in Asian T2DM population are different from what have been observed in the Caucasian T2DM patients. For example, there is BMI discrepancy between T2DM in Western and Eastern countries, more ACEi/ARB side effects (e.g., cough) observed in Asian population, and the possible difference in CKD/ESRD incidence in T2DM between different ethnic groups.
Moreover, the enrollees in most well-known trials (e.g., ADVANCE and ACCORD studies) were those who suffered from at least one cardiovascular risk factor for secondary prevention. To our best knowledge, there is no study designed to evaluate effectiveness of blood pressure control for T2DM patients without previous CV events. Therefore, we initiated a prospective randomized controlled trial to investigate the renal protection effect for tight blood pressure control for Taiwanese T2DM patients without previously diagnosed CV events. We set our primary outcome for the prevention of microalbuminuria development to partly respond to the urgent need for this society in solving the huge burden caused by the high incidence and prevalence of diabetic nephropathy in Taiwan.
The study includes two parts: (1) a RCT trial, (2) an observational cohort study. The recruitment period of this study is from 2013 Oct to 2019 Dec. The RCT trial will be ended in 2019 Dec. In addition, we also intend to continuously follow up all our recruited hypertensive diabetes patients for at least 10 years to observe their clinical outcomes including cardiovascular, renal, retinal outcomes and mortality (the part of the observational cohort study).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tight BP | Active comparator | Combination Product: drug adjustment and behavioral modificationInterventions: anti-hypertension drug prescription by physician and case management by health educator. Blood pressure is targeted at 120/80 mmHg in the tight BP control group. |
| usual BP | Placebo comparator | Combination Product: drug adjustment and behavioral modificationInterventions: The physicians follow their usual care patterns to prescribe anti-HT drugs. Blood pressure is targeted at < 140/90 mmHg in the usual BP control group. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| drug adjustment and behavioral modificationanti-hypertension drug prescription by physician and case management by health educator | Combination product | tight BP, usual BP |
Primary outcome
development of microalbuminuria
Time frame: up to 10 years
indicator of microalbuminuria: urine ACR
3 secondary outcomes
mortality
Time frame: up to 10 years
annual renal function declining rate
Time frame: up to 10 years
development of cardiovascular events
Time frame: up to 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2018.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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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.
Chih-Cheng Hsu, DrPH principal investigator
National Health Research Institutes, Taiwan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing drug adjustment and behavioral modification in people with Type 2 Diabetes Mellitus and Hypertension, run by National Health Research Institutes, Taiwan at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 26 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chih-Cheng Hsu, DrPH (886-37-246166 ext. 36336, cch@nhri.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
development of microalbuminuria (time frame: up to 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Mar 2018; AzTrials last refreshed its copy on 2 Nov 2026.