Type 2 Diabetes MellitusNCT06156696
A Study to Compare the Use of Diabetes Treatment Support System (BAP0527 and Blood Glucose Meter) in Addition to Daily Practice and Treatment With Daily Practice and Treatment Alone in Patients With Type 2 Diabetes Mellitus
A study testing BAP0527 and Blood Glucose Meter in people with Type 2 Diabetes Mellitus, run by Astellas Pharma Inc at 1 site in Japan.
Trial summary
The subjects of this study are patients with type 2 diabetes mellitus. The patients take part in dietetic therapy and exercise therapy, and also receive diabetes education to improve lifestyle habits, but since diet and exercise are lifestyle-based, it is generally difficult to make lifestyle changes and continue… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- BAP0527 and Blood Glucose Meter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 1 siteJapan
- Study dates
- 16 Feb 2024to 10 Sep 2025
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant has been diagnosed with type 2 diabetes for at least 12 weeks (84 days) at visit 1.
- Participants being treated with only diet and exercise therapy, or participants being treated with hypoglycemics other than insulin preparations in addition to diet and exercise therapy, who have continued the same treatment for at least 12 weeks (84 days) as of visit 1.
- Participants who have potential for improvement from self-management of diabetes mellitus, including diet therapy and exercise therapy, and who are willing to improve their self-management of diabetes mellitus, while complying with the rules for participants relating to the use of BAP0527 and the blood glucose meter, as of visit 1.
- Participants who are able to perform outpatient management while participating in this study, as of visit 1.
- Participants have no problems inputting information into BAP0527 or using the blood glucose meter, from the perspective of cognitive function, visual acuity or device operating ability, as of visit 1.
- Participants having and using a smartphone device meeting the following operating system requirements as of visit 1
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- For iOS: Version 13 or later
- For Android: Version 10 or later
- Participants with an HbA1c level >/=8.0% and </=10.0% (central lab measurement) as of visit 1.
- Participants who also meet inclusion criteria from the second to the sixth at visit 2.
- Female participant is not pregnant and at least 1 of the following conditions apply:
- Not a Woman of Childbearing Potential (WOCBP)
- A WOCBP who has a negative urine or serum pregnancy test between the time of providing informed consent and visit 2 and agrees to follow the contraceptive guidance from the time of informed consent through the end of the follow-up period.
- Female participant is consenting not to breastfeed from the time of providing informed consent until the end of the follow-up period.
- Participant agrees not to participate in another interventional study while participating in the present study.
Who cannot join
- Participants diagnosed with a type of diabetes mellitus other than type 2 diabetes mellitus, such as type 1 diabetes mellitus or secondary diabetes mellitus.
- Participants with a history of, or currently receiving treatment for, diabetic ketoacidosis.
- Participants with retinopathy proliferative (however, if treatment such as photocoagulation has been performed and symptoms are stable, the participant may be enrolled).
- Participants diagnosed with clinically problematic cardiovascular or cerebrovascular disease such as myocardial infarction, poorly controlled angina pectoris/coronary artery disease, clinically problematic ventricular arrhythmia, cardiac failure (class III or IV according to the New York Heart Association classification) in the period of 12 weeks (84 days) before visit 1 (including the date of visit 1).
- Participants with chronic disease requiring continuous use (such as oral use or injection) of adrenocortical steroids or immunosuppressants for their systemic action.
- Participants with a concurrent malignant tumor (with a relapse-free period of less than 5 years).
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- Participants with concurrent serious infection.
- Participants with concurrent serious hepatic disorder.
- Participants with drug addiction, alcohol dependence or unstable psychiatric disease.
- Participants using insulin preparations.
- Participants who plan to be hospitalized or receive surgery during the period of participants in this study.
- Participants who have already been assigned in this study.
- Participants who receive any study treatment (including a follow-up period) in the period of 12 weeks (84 days) before visit 1 (including the date of visit 1) or who participate in any study treatment, when 5 half-lives of this treatment have not elapsed as of 12 weeks (84 days) before visit 1.
- Participants who have used a mobile application operating on a smartphone device for managing, or assisting in the management of, diabetes mellitus in the 12 weeks (84 days) before visit 1 (including the date of visit 1), when judged that the possibility of this history of use affecting efficacy evaluation in this study cannot be ruled out.
- Participants with a difference of more than 1.0% in the maximum and minimum HbA1c levels (measured at the hospital) measured in the 12 weeks (84 days) before visit 1 (including the date of visit 1).
- Participants with systolic blood pressure (SBP) >180 mmHg or diastolic blood pressure (DBP) >110 mmHg at rest in a sitting position at either visit 1, visit 2 or both or participants with SBP>160 mmHg or DBP >100 mmHg at rest in a sitting position at both visit 1 and visit 2.
- Participants with concurrent diabetic nephropathy of stage 3 or higher (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73m^2 or urinary albumin >/= 300 mg/gCre [each centrally measured values at visit 1]).
- Participants who have and use a smartphone device on which BAP0527 may not be displayed appropriately, or who plan to buy a new smartphone device on which BAP0527 may not be displayed appropriately between the time of providing informed consent and the end of the treatment period.
- Participants who are employees of Astellas Group, Welldoc, Inc., Roche DC Japan K.K. or a study site, or the CRO involved in the study.
- Participant has any condition, which makes the participant unsuitable for study participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter, Randomized, Open-label Study of Diabetes Treatment Support System (BAP0527 and Blood Glucose Meter) in Patients With Type 2 Diabetes Mellitus
The subjects of this study are patients with type 2 diabetes mellitus. The patients take part in dietetic therapy and exercise therapy, and also receive diabetes education to improve lifestyle habits, but since diet and exercise are lifestyle-based, it is generally difficult to make lifestyle changes and continue self-management for diabetes management.
The objective of this study is to determine whether the use of a diabetes treatment support system (BAP0527 and blood glucose meter, hereafter, this product) would allow type 2 diabetes mellitus patients to control their blood glucose well.
Read more
BAP0527 is a modified Japanese version of BlueStar®, a smartphone application approved by the U.S. Food and Drug Administration to manage and support the treatment of diabetes in adults. The blood glucose meter is a device that measures blood glucose levels from fingertips and palm blood using a dedicated paracentesis device (a device used to draw blood). In this study, BAP0527 will be used in conjunction with the blood glucose meter.
This study is open-label. Open-label means that subjects participating in this study are aware of whether they use this product in addition to their daily practice and treatment. Whether a subject uses this product or not is determined randomly. The subjects in the group using this product will be required to install BAP0527 on their smartphones and record their lifestyle habits (diet, exercise, sleep), medication compliance, blood pressure, pulse, weight, and also blood glucose levels measured by the blood glucose meter. In addition, they will review lifestyle habits according to the messages sent by BAP0527 based on the inputs, and watch educational contents. On the other hand, subjects in the group not using this product will continue to receive the treatment they have taken before participating in the study.
The study period is approximately 10 months. During this period, a subject will visit a hospital approximately 12 times. For subjects in the group who use this product, the duration of use of this product is approximately 6 months.
When a subject visits a hospital, a study doctor will confirm if the subject has a health problem. In addition, laboratory test, body temperature, blood pressure, and pulse will be confirmed. Blood/urine samples will be collected from subjects for laboratory tests.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- BAP0527, Blood Glucose Meter
- Keywords
- type 2 diabetes mellitus (T2DM), BAP0527, Blood Glucose Meter, Diabetes treatment support system, Digital health product, Self-monitoring of blood glucose (SMBG)
- 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.
BAP0527Device
Participants will continuously use BAP0527, while measuring their daily blood glucose levels using the blood glucose meter, and will input daily self-management records such as lifestyle habits (diet, exercise, sleep), use of medication and measurements (blood glucose level, blood pressure, pulse rate, body weight) into BAP0527.
Blood Glucose MeterDevice
Also called ACCU-CHEK® Guide Me
Participants measure blood glucose using a blood glucose meter in daily life.
| Study group | Role | What they receive |
|---|---|---|
| BAP0527 group | Experimental | Participants use the BAP0527 and Blood Glucose Meter in addition to the usual treatment at each site. Receives: Device: BAP0527; Device: Blood Glucose Meter |
| Usual treatment group | No intervention | Participants receive the usual treatment they received before participating in the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in HbA1c Level at Week 24
The change from Baseline in HbA1c level at Week 24 (central lab measurement) was defined by the formula: HbA1c level at Week 24 - HbA1c level at Baseline. A negative change indicated a reduction/improvement from Baseline (i.e. a favorable outcome). If the HbA1c level at Week 24 was missing, the analysis was conducted using an MMRM under the assumption that data were missing at random (MAR).
Measured: Baseline and Week 24
Secondary outcomes (12)
Change From Baseline in HbA1c Level at Each Assessment Timepoint (Except Week 24)
The change from Baseline in HbA1c level at each assessment time point (except Week 24) (central lab measurement) was defined by the formula: HbA1c level at each assessment time point (Weeks 4 to 20) - HbA1c level at Baseline. A negative change indicated a reduction/improvement from Baseline (i.e. a favorable outcome). If the HbA1c level at each assessment time point (except Week 24) was missing, the analysis was conducted using an MMRM under the assumption that data were MAR.
Measured: Baseline and Weeks 4, 8, 12, 16, and 20
Percentage of Participants With a Baseline HbA1c Level ≥ 8.0% Who Achieved an HbA1c Level < 8.0% at Week 24
The percentage of participants with a Baseline HbA1c level ≥ 8.0% who achieved an HbA1c level < 8.0% at Week 24 (central lab measurement) was defined by the formula: (number of participants with an HbA1c level ≥ 8.0% at Baseline and an HbA1c level < 8.0% at Week 24) / (Number of participants with an HbA1c level ≥ 8.0% at Baseline). If the HbA1c level at Week 24 was missing, the imputed HbA1c level under the assumption of MAR was used.
Measured: Week 24
Change From Baseline Value in Fasting Blood Glucose Level at Week 24
The change from Baseline in fasting blood glucose level at Week 24 (central lab measurement) was defined by the formula: fasting blood glucose level at Week 24 - fasting blood glucose level at Baseline. A negative change indicates a reduction/improvement from Baseline (i.e. a favorable outcome). If the fasting blood glucose level at Week 24 was missing, the analysis was conducted using an MMRM under the assumption that data were MAR.
Measured: Baseline and Week 24
Change From Baseline Value in Fasting Insulin Level at Week 24
The change from Baseline in fasting insulin level at Week 24 (central lab measurement) was defined by the formula: fasting insulin level at Week 24 - fasting insulin level at Baseline. A negative change indicates a reduction/improvement from Baseline (i.e. a favorable outcome). If the fasting insulin level at Week 24 was missing, the analysis was conducted using an MMRM under the assumption that data were MAR.
Measured: Baseline and Week 24
Percentage of Participants With a Decreased Dose of Antidiabetics or Reduced Number of Antidiabetics by Week 24, Relative to Antidiabetic Use at Baseline
The percentage of participants with a decreased dose of antidiabetics or reduced number of antidiabetics by Week 24, relative to antidiabetic use at Baseline, was defined by the formula: (number of participants who use antidiabetics at Baseline and then have a decreased dose of antidiabetics or reduced number of antidiabetics by Week 24 relative to antidiabetic use at Baseline) / (number of participants who use antidiabetics at Baseline). A decreased dose of antidiabetics or reduced number of antidiabetics was defined as cases where the dose of antidiabetics is decreased or the number of antidiabetics is reduced at least once by Week 24 compared with the dose or number of antidiabetics at Baseline.
Measured: Baseline up to Week 24
Percentage of Participants With an Increased Dose of Antidiabetics or Newly Started Hypoglycemics by Week 24, Relative to Antidiabetic Use at Baseline
The percentage of participants with an increased dose of antidiabetics or newly started hypoglycemics by Week 24, relative to antidiabetic use at Baseline, was defined by the formula: (number of participants in the FAS with an increased dose of antidiabetics or newly started hypoglycemics by Week 24 relative to antidiabetic use at Baseline) / (number of participants in the FAS). An increased dose of antidiabetics or newly started hypoglycemics was defined as cases where the dose of antidiabetics is increased at least once or a hypoglycemic is added at least once by Week 24 compared with the dose of antidiabetics or the number of hypoglycemics at Baseline.
Measured: Baseline up to Week 24
Change From Baseline in HbA1c Level in the Follow-up Period
The change from Baseline in HbA1c level at each assessment time point in the follow-up period (central lab measurement) is defined by the formula: HbA1c level at each assessment time point (Weeks 28 to 36) - HbA1c level at Baseline. A negative change indicates a reduction/improvement from Baseline (i.e. a favorable outcome). If the HbA1c level at each assessment time point (Weeks 28 to 36) was missing, the analysis was conducted using an MMRM under the assumption that data were MAR.
Measured: Baseline and Weeks 28, 32 and 36
Change From Week 24 in HbA1c Level in the Follow-up Period
The change from Week 24 in HbA1c level at each assessment time point in the follow-up period (central lab measurement) is defined by the formula: HbA1c level at each assessment time point (Weeks 28 to 36) - HbA1c level at Week 24. A negative change indicates a reduction/improvement from Week 24 (i.e. a favorable outcome). If the HbA1c level at each assessment time point (Weeks 28 to 36) was missing, the analysis was conducted using an MMRM under the assumption that data were MAR.
Measured: Week 24 and Weeks 28, 32 and 36
Percentage of Participants With a Decreased Dose of Antidiabetics or Reduced Number of Antidiabetics by Week 12 of the Follow-up Period, Relative to Antidiabetic Use at Week 24
The percentage of participants with a decreased dose of antidiabetics or reduced number of antidiabetics by Week 12 of the follow-up period, relative to antidiabetic use at Week 24, is defined by the formula: (number of participants who start the follow-up, use antidiabetics at Week 24, and have a decreased dose of antidiabetics or reduced number of antidiabetics between Week 28 and Week 36 relative to antidiabetic use at Week 24) / (number of participants who start the follow-up and use antidiabetics at Week 24). A decreased dose of antidiabetics or reduced number of antidiabetics was defined as cases where the dose of antidiabetics was decreased or the number of antidiabetics was reduced at least once between Week 28 and Week 36 compared with the dose or number of antidiabetics at Week 24.
Measured: Week 24 up to Week 36
Percentage of Participants With an Increased Dose of Antidiabetics or Newly Started Hypoglycemics by Week 12 of the Follow-up Period, Relative to Antidiabetic Use at Week 24
The percentage of participants with an increased dose of antidiabetics or newly started hypoglycemics by Week 12 of the follow-up period, relative to antidiabetic use at Week 24, is defined by the formula: (Number of participants in the FAS2 with an increased dose of antidiabetics or newly started hypoglycemics between Week 28 and Week 36 relative to antidiabetic use at Week 24) / (Number of participants in the FAS2). An increased dose of antidiabetics or newly started hypoglycemics is defined as cases where the dose of antidiabetics is increased at least once or a hypoglycemic is added at least once between Week 28 and Week 36 compared with the dose of antidiabetics or the number of hypoglycemics at Week 24.
Measured: Week 24 up to Week 36
Number of Participants With Adverse Events (AEs)
An AE is any untoward medical occurrence in a patient, clinical study participant, user or other person, temporally associated with the use of study intervention, whether or not considered related to the study intervention. NOTE: An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. This includes events related to the device used in the clinical study, if applicable, and events related to the (study) procedures.
A device-related AE is an AE that is related to the use of a device used in the clinical study. This includes AEs caused by an omission in the instruction manual for the use, dispensing or operation of a device used in the clinical study, or a deficiency in the device used in the clinical study. It also includes AEs occurring due to the improper use (including intentional improper use) of a device used in the clinical study.
Measured: From Day 1 up to Week 36
Number of Participants Who Experienced Device Deficiency
A deficiency in a device is the situation where a device used in the clinical study is broadly in a poor condition in relation to quality, safety or performance, such as device damage or malfunctions, regardless of whether this occurs at the stage of design, dispensing, storage or use.
Measured: From Day 1 up to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start16 Feb 2024
- Primary completion2 Jul 2025
- Study completion10 Sep 2025
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.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 248 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06156696
- Sponsor's protocol ID
- 0527-CL-0002
- Other IDs
- jRCT2032230521
- Status last verified
- Jul 2026
- First submitted
- 26 Nov 2023
- Last updated
- 30 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Open-label Study of Diabetes Treatment Support System (BAP0527 and Blood Glucose Meter) in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT06156696
- Acronym / sponsor ID
- 0527-CL-0002
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- type 2 diabetes mellitus (T2DM), BAP0527, Blood Glucose Meter, Diabetes treatment support system, Digital health product, Self-monitoring of blood glucose (SMBG)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 248 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- 16 Feb 2024 (actual)
- Primary completion
- 2 Jul 2025 (actual)
- Study completion
- 10 Sep 2025 (actual)
- First posted
- 5 Dec 2023 (actual)
- Results
- Posted 30 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The subjects of this study are patients with type 2 diabetes mellitus. The patients take part in dietetic therapy and exercise therapy, and also receive diabetes education to improve lifestyle habits, but since diet and exercise are lifestyle-based, it is generally difficult to make lifestyle changes and continue self-management for diabetes management.
The objective of this study is to determine whether the use of a diabetes treatment support system (BAP0527 and blood glucose meter, hereafter, this product) would allow type 2 diabetes mellitus patients to control their blood glucose well.
BAP0527 is a modified Japanese version of BlueStar®, a smartphone application approved by the U.S. Food and Drug Administration to manage and support the treatment of diabetes in adults. The blood glucose meter is a device that measures blood glucose levels from fingertips and palm blood using a dedicated paracentesis device (a device used to draw blood). In this study, BAP0527 will be used in conjunction with the blood glucose meter.
This study is open-label. Open-label means that subjects participating in this study are aware of whether they use this product in addition to their daily practice and treatment. Whether a subject uses this product or not is determined randomly. The subjects in the group using this product will be required to install BAP0527 on their smartphones and record their lifestyle habits (diet, exercise, sleep), medication compliance, blood pressure, pulse, weight, and also blood glucose levels measured by the blood glucose meter. In addition, they will review lifestyle habits according to the messages sent by BAP0527 based on the inputs, and watch educational contents. On the other hand, subjects in the group not using this product will continue to receive the treatment they have taken before participating in the study.
The study period is approximately 10 months. During this period, a subject will visit a hospital approximately 12 times. For subjects in the group who use this product, the duration of use of this product is approximately 6 months.
When a subject visits a hospital, a study doctor will confirm if the subject has a health problem. In addition, laboratory test, body temperature, blood pressure, and pulse will be confirmed. Blood/urine samples will be collected from subjects for laboratory tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BAP0527 group | Experimental | Device: BAP0527, Device: Blood Glucose MeterParticipants use the BAP0527 and Blood Glucose Meter in addition to the usual treatment at each site. |
| Usual treatment group | No intervention | –Participants receive the usual treatment they received before participating in the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Participant has been diagnosed with type 2 diabetes for at least 12 weeks (84 days) at visit 1.
- Participants being treated with only diet and exercise therapy, or participants being treated with hypoglycemics other than insulin preparations in addition to diet and exercise therapy, who have continued the same treatment for at least 12 weeks (84 days) as of visit 1.
- Participants who have potential for improvement from self-management of diabetes mellitus, including diet therapy and exercise therapy, and who are willing to improve their self-management of diabetes mellitus, while complying with the rules for participants relating to the use of BAP0527 and the blood glucose meter, as of visit 1.
- Participants who are able to perform outpatient management while participating in this study, as of visit 1.
- Participants have no problems inputting information into BAP0527 or using the blood glucose meter, from the perspective of cognitive function, visual acuity or device operating ability, as of visit 1.
Key exclusion criteria (20 listed)
- Participants diagnosed with a type of diabetes mellitus other than type 2 diabetes mellitus, such as type 1 diabetes mellitus or secondary diabetes mellitus.
- Participants with a history of, or currently receiving treatment for, diabetic ketoacidosis.
- Participants with retinopathy proliferative (however, if treatment such as photocoagulation has been performed and symptoms are stable, the participant may be enrolled).
- Participants diagnosed with clinically problematic cardiovascular or cerebrovascular disease such as myocardial infarction, poorly controlled angina pectoris/coronary artery disease, clinically problematic ventricular arrhythmia, cardiac failure (class III or IV according to the New York Heart Association classification) in the period of 12 weeks (84 days) before visit 1 (including the date of visit 1).
- Participants with chronic disease requiring continuous use (such as oral use or injection) of adrenocortical steroids or immunosuppressants for their systemic action.
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 |
|---|---|---|
| BAP0527Participants will continuously use BAP0527, while measuring their daily blood glucose levels using the blood glucose meter, and will input daily self-management records such as lifestyle habits (diet, exercise, sleep), use of medication and measurements (blood glucose level, blood pressure, pulse rate, body weight) into BAP0527. | Device | BAP0527 group |
| Blood Glucose MeterAlso: ACCU-CHEK® Guide MeParticipants measure blood glucose using a blood glucose meter in daily life. | Device | BAP0527 group |
Primary outcome
Change From Baseline in HbA1c Level at Week 24
Time frame: Baseline and Week 24
The change from Baseline in HbA1c level at Week 24 (central lab measurement) was defined by the formula: HbA1c level at Week 24 - HbA1c level at Baseline. A negative change indicated a reduction/improvement from Baseline (i.e. a favorable outcome). If the HbA1c level at Week 24 was missing, the analysis was conducted using an MMRM under the assumption that data were missing at random (MAR).
12 secondary outcomes
Change From Baseline in HbA1c Level at Each Assessment Timepoint (Except Week 24)
Time frame: Baseline and Weeks 4, 8, 12, 16, and 20
Percentage of Participants With a Baseline HbA1c Level ≥ 8.0% Who Achieved an HbA1c Level < 8.0% at Week 24
Time frame: Week 24
Change From Baseline Value in Fasting Blood Glucose Level at Week 24
Time frame: Baseline and Week 24
Change From Baseline Value in Fasting Insulin Level at Week 24
Time frame: Baseline and Week 24
Percentage of Participants With a Decreased Dose of Antidiabetics or Reduced Number of Antidiabetics by Week 24, Relative to Antidiabetic Use at Baseline
Time frame: Baseline up to Week 24
Percentage of Participants With an Increased Dose of Antidiabetics or Newly Started Hypoglycemics by Week 24, Relative to Antidiabetic Use at Baseline
Time frame: Baseline up to Week 24
Change From Baseline in HbA1c Level in the Follow-up Period
Time frame: Baseline and Weeks 28, 32 and 36
Change From Week 24 in HbA1c Level in the Follow-up Period
Time frame: Week 24 and Weeks 28, 32 and 36
Percentage of Participants With a Decreased Dose of Antidiabetics or Reduced Number of Antidiabetics by Week 12 of the Follow-up Period, Relative to Antidiabetic Use at Week 24
Time frame: Week 24 up to Week 36
Percentage of Participants With an Increased Dose of Antidiabetics or Newly Started Hypoglycemics by Week 12 of the Follow-up Period, Relative to Antidiabetic Use at Week 24
Time frame: Week 24 up to Week 36
Number of Participants With Adverse Events (AEs)
Time frame: From Day 1 up to Week 36
Number of Participants Who Experienced Device Deficiency
Time frame: From Day 1 up to Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BAP0527 and Blood Glucose Meter in people with Type 2 Diabetes Mellitus, run by Astellas Pharma Inc at 1 site in Japan.
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 15 inclusion and 20 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 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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 30 Sep 2026). 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?
Change From Baseline in HbA1c Level at Week 24 (time frame: Baseline and Week 24). 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 30 Sep 2026.