Multicenter, Randomized, Open-label Study of Diabetes Treatment Support System (BAP0527 and Blood Glucose Meter) in Patients with Type 2 Diabetes Mellitus
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
Yamada Emi
Astellas Pharma Inc.
2-5-1, Nihonbashi-Honcho, Chuo-ku, Tokyo
+81-120-189-371
clinicaltrialregistration@astellas.com
Medical Information Center
Astellas Pharma Inc.
2-5-1, Nihonbashi-Honcho, Chuo-ku, Tokyo
+81-120-189-371
clinicaltrialregistration@astellas.com
Complete
Feb. 01, 2024
Feb. 16, 2024
248
Interventional
randomized controlled trial
open(masking not used)
no treatment control/standard of care control
parallel assignment
treatment purpose
1. Participant has been diagnosed with type 2 diabetes for at least 12 weeks (84 days) at visit 1.
2. 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.
3. 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.
4. Participants who are able to perform outpatient management while participating in this study, as of visit 1.
5.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.
6. Participants having and using a smartphone device meeting the following operating system requirements as of visit 1.
- For iOS: Version 13 or later
- For Android: Version 10 or later
7. Participants with an HbA1c level >/= 8.0 % and </= 10.0 % (central lab measurement) as of visit 1.
8. Participants who also meet inclusion criteria 2 to 6 at visit 2.
9. Female participant:
o Female participant is not pregnant and at least 1 of the following conditions apply:
- Not a Women of Childbearing Potential (WOCBP)
- 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
o Female participant is consenting not to breastfeed from the time of providing informed consent until the end of the follow-up period.
10. Participant agrees not to participate in another interventional study while participating in the present study.
1. Participants diagnosed with a type of diabetes mellitus other than type 2 diabetes mellitus, such as type 1 diabetes mellitus or secondary diabetes mellitus.
2. Participants with a history of, or currently receiving treatment for, diabetic ketoacidosis.
3. Participants with retinopathy proliferative (however, if treatment such as photocoagulation has been performed and symptoms are stable, the participant may be enrolled).
4. 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).
5. Participants with chronic disease requiring continuous use (such as oral use or injection) of adrenocortical steroids or immunosuppressants for their systemic action.
6. Participants with a concurrent malignant tumor (with a relapse-free period of less than 5 years).
7. Participants with concurrent serious infection.
8. Participants with concurrent serious hepatic disorder.
9. Participants with drug addiction, alcohol dependence or unstable psychiatric disease.
10. Participants using insulin preparations.
11. Participants who plan to be hospitalized or receive surgery during the period of participants in this study.
12. Participants who have already been assigned in this study.
13. 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.
14. 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.
15. 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).
16. 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.
17. 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]).
18. 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.
19. 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.
20. Participant has any condition, which makes the participant unsuitable for study participation.
18age old over
No limit
Both
Type 2 Diabetes Mellitus
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.
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.
The 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.
Change from baseline in HbA1c level at Week 24 (central lab measurement)
o Change from baseline in HbA1c level at each assessment time point (except Week 24) (central lab measurement)
o Percentage of participants with a baseline HbA1c level >/= 8.0% who achieved an HbA1c level < 8.0% at Week 24 (central lab measurement)
o Change from baseline in fasting blood glucose level and fasting insulin
level at Week 24 (central lab measurement)
o Percentage of participants with a decreased dose of antidiabetics or reduced number of antidiabetics by Week 24, relative to antidiabetic use at baseline
o Percentage of participants with an increased dose of antidiabetics or newly started hypoglycemics by Week 24, relative to antidiabetic use at baseline
o Change from baseline in HbA1c level at each assessment time point during the follow-up period (central lab measurement)
o Change from Week 24 in HbA1c level at each assessment time point during the follow-up period (central lab measurement)
o 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
o 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
o AEs, deficiencies, laboratory test values (hematology, blood biochemistry, urinalysis), vital signs
Astellas Pharma Inc.
Medical Corporation Shintokai Yokohama Minoru Clinic Institutional Review Board. Even when there are more than one IRB in this trial, only one IRB's name is presented.
1-13-8, Bessho, Minami-ku, Yokohama-shi, Kanagawa
+81-42-648-5551
yminoru-irb@eps.co.jp
Approval
Dec. 15, 2023
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/.
