Examination of gastrointestinal effects of luseogliflozin

JRCT ID: jRCTs051240181

Registered date:11/11/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patients with type 2 diabetes mellitus
• Date of first enrollment: 11/11/2024
• Target sample size: 30
• Study type: Interventional

Intervention(s)

magnetic resonance enterography
luseogliflozin administration

Outcome(s)

• Primary Outcome: Hourly excretion of glucose into the intestinal lumen after 12 weeks

Secondary Outcome

Changes in HbA1c, fasting blood glucose, body weight and various clinical parameters before and after treatment with luseogliflozin
Relationship between intestinal glucose excretion and various clinical parameters in luseogliflozin-administered and -non-administered groups
Urinary glucose excretion during PET testing
No occurrence of disease
Changes in the intestinal environment from the start of luseogliflozin administration to 12 weeks after the start of treatment

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 80age old
• Gender: Both

Include criteria

1. Patients with type 2 diabetes whose HbA1c is 6% or higher but less than 8%
2. Patients taking only diet and exercise therapy or DPP-4 inhibitors without dosage modification as treatment for diabetes for at least 2 months prior to obtaining consent
3. Patients without known malignancy, history of bowel resection, or inflammatory bowel disease in the lower gastrointestinal tract
4. Patients who are over 20 years old and within 80 years old at the time of obtaining consent
5. Patients who have given their voluntary written consent to participate in this clinical study

Exclude criteria

1. Patients with the following contraindications to butylscopolamine bromide
2. Patients with dementia or psychiatric disorders
3. Patients with intestinal perforation or obstruction
4. Patients with metals in the body that are not amenable to PET/MRE testing
5. Pregnant or breast feeding patients
6. Patients with claustrophobia
7. Patients with a history of hypersensitivity to luseogliflozin
8. Patients with severe renal dysfunction (eGFR<30 mL/min/1.73m2)
9. Patients with severe hepatic dysfunction(AST and ALT more than 2.5 times the upper limit of normal)
10. Patients who have used antibiotics or anti-parasitic drugs within 1 month prior to eligibility verification
11. Patients who have taken PPIs (proton pump inhibitors), steroids, immunosuppressive drugs, probiotic drugs, osmotic laxatives, amino acid preparations, or bile acid secretion promoters within 1 month prior to eligibility verification
12. Other patients deemed inappropriate by the clinical study investigator or sub-investigator

Related Information

• Primary Sponsor: Sakaguchi Kazuhiko
• Source(s) of Monetary Support: Taisho Pharmaceutical Co.