Patients with type 2 diabetes mellitus
Conditions
Interventions
magnetic resonance enterography
luseogliflozin administration
Sponsors
Sakaguchi Kazuhiko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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
Exclusion criteria
Exclusion 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 4 times the upper limit of normal, or Child-Pugh classification Class C) 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hourly excretion of glucose into the intestinal lumen after 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Contacts
Public ContactHayato Fukumitsu
Kobe University Hospital
Outcome results
None listed