Gifu Metformin and Seirogan Study

JRCT ID: jRCTs041220146

Registered date:24/02/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Type 2 Diabetes Mellitus
• Date of first enrollment: 24/02/2023
• Target sample size: 30
• Study type: Interventional

Intervention(s)

Group A:500 mg of metformin hydrochloride taken orally three times a day after each meal.
Group B:500 mg of metformin hydrochloride taken orally three times a day after each meal. In addition, Seirogan Quick C, 2 caps (90 mg of wood creosote as the main ingredient) is taken orally three times a day after each meal.
Study subjects will continue for up to 12 (+-2) weeks from the start of the intervention.

Outcome(s)

• Primary Outcome: Number of days of diarrhoea from baseline to 4 weeks after observation point

Secondary Outcome

1. number of days of diarrhea from baseline to 1 week.
2. number of days of diarrhea from baseline to 12 (+-2) weeks.
3. rate of metformin medication retention from baseline to 4 (+-1) weeks.
4. average number of bowel movements per day from baseline to 4 (+-1) weeks.
5. average number of bowel movements per day from baseline to 12 (+-2) weeks.
6. change in stool properties (Bristol scale) from baseline to 4 (+-1) weeks.
7. change in stool properties (Bristol scale) from baseline to 12 (+-2) weeks.
8. incidence of gastrointestinal symptoms(abdominal cramping, nausea and vomitting ) from baseline to 12 (+-2) weeks.
9. change in HbA1c from baseline to 12 (+-2) weeks.
10. weight change from baseline to 12 (+-2) weeks.
11. change in body composition (BIA method) from baseline to 12 (+-2) weeks.
12. change in energy intake/nutrient ratios (FFQ) from baseline to 12 (+-2) weeks.
13. change in gut microbiota from baseline to 4 (+-1) weeks.
14. change in gut microbiota from baseline to 12 (+-2) weeks.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 75age old
• Gender: Both

Include criteria

Patients who meet all of the following criteria are included in this study;
1) Patients with type 2 diabetes.
2) Patients aged 18 years and over but less than 75 yearsat the time of obtaining consent.
3) Patients not receiving treatment with (1) hypoglycaemic drugs at the time of obtaining consent, or (2) Patients using one or two of the following drugs as hypoglycaemic agents: sulfonylureas, glinides, thiazolidinediones or SGLT-2 inhibitors.
4) Patients whome HbA1c is 6.5~9.0% at the time of obtaining consent if they are (1) not receiving treatment with hypoglycaemic agents or using one or two thiazolidinediones or SGLT2 inhibition, or (2) using one or two sulfonylureas or glinides, 7. 0~9.0% patients
5) Patients with a BMI of 18 kg/m2 or higher at giving their consent.
6) Patients whose provide their consent in a written from by themselves.

Exclude criteria

excluded from the study.
1)Patients who had diarrhoea symptoms for at least 3 days in the week prior to enrolment
2)Patients with chronic diarrhoea, including inflammatory bowel disease, and patients using lactic acid bacteria or other intestinal regulators.
3)Patients who have been taking biguanide drugs continuously within the past four weeks, or who are using a wood creosote-containing antidiarrhoeal drug.
4)Patients on treatment with insulin or GLP-1 receptor agonists, DPP-4 inhibitors, alpha-glucosidase inhibitors or imeglimine with in the past four weeks.
5)Patients with severe renal impairment (eGFR < 45 mL/min/1.73 m2)
6)Patients with severe hepatic dysfunction (blood levels of either ALT, AST or ALP exceeding 2.5 times the upper limit of normal [ULN]), cirrhosis
7)Patients with severe diabetic retinopathy (proliferative retinopathy, vitreous haemorrhage or more clinically significant abnormalities)
8)Patients with a history of gastrointestinal surgery (not including endoscopic procedures)
9)Patients with a history of malignancy within the last five years
10)Patients with severe infections, pre- or post-operative or severe trauma.
11) Patients with a diagnosis of alcohol dependence
12) Pregnant or lactating women
13) Patients who have difficulty in complying with the instructions of the principal investigator or research assistant.
14) Patients participating in other clinical trials, clinical research, etc.
15) Other patients deemed unsuitable for the study by the principal investigator or a sub-investigator.

Related Information

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