Patients with type 2 diabetes
Conditions
Interventions
magnetic resonance enterography
Imeglimin
Sponsors
Kazuhiko Sakaguchi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with type 2 diabetes medically considered to require glycemic control with additional medication 2. Patients not taking imeglimin for at least 1 month prior to obtaining consent 3. [Imeglimin alone group] patients not taking metformin for at least 1 month prior to obtaining consent, and [Imeglimin and metformin combination group] patients taking metformin (more than 1000 mg per day) for at least 1 month prior to obtaining consent 4. Patients without the lower gastrointestinal tract disease 5. Patients who are over 20 years old and within 80 years old at the time of obtaining consent 6. 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. Other patients deemed inappropriate by the investigators in charge of this clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| FDG excretion per hour into the intestinal lumen | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in fasting blood glucose level before and after imeglimin administration Changes in insulin level before and after imeglimin administration Changes in glycoalbumin before and after imeglimin administration Clinical parameters such as HbA1c, blood glucose level, and other parameters New occurrence of adverse disease Gastrointestinal symptoms Bristol stool scale | — |
Contacts
Public ContactYamada Tomoko
Kobe University Hospital
Outcome results
None listed