Examination of gastrointestinal effects of imeglimin

JRCT ID: jRCTs051220192

Registered date:15/03/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patients with type 2 diabetes
• Date of first enrollment: 15/03/2023
• Target sample size: 10
• Study type: Interventional

Intervention(s)

magnetic resonance enterography
Imeglimin

Outcome(s)

• Primary Outcome: FDG excretion per hour into the intestinal lumen

Secondary Outcome

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

Key inclusion & exclusion criteria

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

Include 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

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. Other patients deemed inappropriate by the investigators in charge of this clinical study

Related Information

• Primary Sponsor: Kazuhiko Sakaguchi