BALLAST study

JRCT ID: jRCTs041210048

Registered date:06/08/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Type 2 Diabetes Mellitus
• Date of first enrollment: 06/08/2021
• Target sample size: 88
• Study type: Interventional

Intervention(s)

Group A: Luseogliflozin administration group (luseogliflozin + protein intake + exercise therapy)
Group B: Control group (protein intake + exercise therapy)

Outcome(s)

• Primary Outcome: Change in HbA1c from baseline (week 0) to week 52

Secondary Outcome

1. Change in body weight from baseline (week 0) to week 52
2. Change in body composition measured by BIA method from baseline (week 0) to week 52
3. Change in handgrip from baseline (week 0) to week 52
4. Change in frequency of meal intake from baseline (week 0) to week 52
5. Change in HOMA-IR from baseline (week 0) to week 52
6. Change in inflammatory cytokine (IL-6, TNF-alpha) from baseline (week 0) to week 52
7. Frequency of adverse event or disease-or-the-like from baseline (week 0) to week 52

Key inclusion & exclusion criteria

• Age minimum: >= 70age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Patients who meet all of the following criteria are included in this study;
1) Patients with type 2 diabetes mellitus.
2) Male and female aged 65 years or older at giving their consent.
3) Patients who do not take any oral hypoglycemic agents (OHAs) at giving their consent, or who take only one OHA among sulfonylurea, glinide, alpha-glucosidase inhibitor, DPP-4 inhibitor, metformin, or pioglitazone.
4) Patients whose HbA1c is 7.0% or higher and 9.0% or less in case of OHA-untreated patients, or patients whose HbA1c is 6.0% or higher and 8.0% or less in case of patients who take one OHA.
5) Patients whose BMI is 18 kg/m2 or higher and 30 kg/m2 or less at giving their consent.
6) Male whose SMI is 7.0 kg/m2 or higher, or female whose SMI is 5.7 kg/m2 or higher at giving their consent.
7) Male whose handgrip (mean of right and left handgrip) is 28 kg or higher, or female whose handgrip is 18 kg or higher at giving their consent.
8) Patients who provide their consent in a written form by themselves.

Exclude criteria

Patients who fall into any of the following criteria are excluded from participating in the study;
1) Patients with severe renal dysfunction (eGFR of less than 30 mL/min/1.73m2).
2) Patients who are treated with insulin or GLP-1 receptor agonists.
3) Patients who continuously take leucine-containing amino acids within 12 weeks before giving their consent.
4) Patients who have watched the patient participation type movie "recommendation for exercise therapy" (released by Japan Association for Diabetes Education and Care), and who strengthened the exercise therapy.
5) Patients who have history of cerebrovascular or cardiovascular impairment.
6) Patients with heart failure (NYHA classification II to iV)
7) Patients with severe hepatic dysfunction (any of ALT, AST or ALP is more than 3 times of Upper Limit of Normal.
8) Patients who have history of pancreatitis.
9) Patients with diabetic retinopathy (patients with proliferative retinopathy, vitreous hemorrhage, or other severe clinical abnormality).
10) Patients who have history of gastrointestinal tract surgery.
11) Patients who have history of malignant tumor within 5 years before giving their consent.
12) Patients with severe infection or trauma, or in the perioperative period.
13) Patients with excess drinking habit (5 days or more per week)
14) Patients whose latest hemoglobin before giving their consent is less than 11.0 g/dL.
15) Patients who have difficultiey following the instructions of the responsible investigator or subinvestigators.
16) Patients who are participating in other clinical studies.
17) Patients with other conditions that the responsible investigator or subinvestigators think inappropriate to participate in the study.

Related Information

• Primary Sponsor: Yabe Daisuke
• Source(s) of Monetary Support: Taisho Pharmaceutical Co., Ltd.