臨床研究等提出・公開システム

A randomised, open-label trial to assess the effect of tirzepatide or semaglutide versus conventional treatment on gut microbiota in Japanese patients with type 2 diabetes

Osaka Metropolitan Diabetes & Obesity Trial 1 (OMDOT-1)

Emoto Masanori

Department of Metabolism, Endocrinology, and Molecular Medicine, Osaka Metropolitan University Graduate School of Medicine

1-4-3, Asahi-machi, Abeno-ku, Osaka, 545-8585, Japan

emoto-m@omu.ac.jp

Morioka Tomoaki

Department of Metabolism, Endocrinology, and Molecular Medicine, Osaka Metropolitan University Graduate School of Medicine

1-4-3, Asahi-machi, Abeno-ku, Osaka, 545-8585, Japan

+81-6-6645-3806

moriokatmed@omu.ac.jp

Recruiting

May. 07, 2024

Interventional

randomized controlled trial

open(masking not used)

no treatment control/standard of care control

parallel assignment

other

1. Patients with type 2 diabetes attending the facility during the trial period
2. Age >= 20 years and <80 year at the time of signing informed consent
3. Diagnosed with type 2 diabetes at least 180 days prior to screeing
4. Currently treated with metformin
5. If receiving oral antihyperglycemic drugs other than metformin and/or insulin, the type of drugs has not changed for at least 3 months (changes in dosage of the same drug are allowed).
6. HbA1c >= 7.0% and <10% at screening
7. BMI >= 23 kg/m2 at screening and beeing stable within 5% for the past 3 months
8. Able to carry out stable diet and exercise therapy during the research period

1. History of type 1 diabetes
2. History of either chronic or acute pancreatitis
3. Uncontrolled and potentially unstable diabetic retinopathy or maculopathy at screening
4. Any history or evidence of chronic liver disease other than metabolic dysfunction-associated fatty liver disease (MAFLD) or AST and/or ALT >3x upper limit of normal range
5. Impaired renal function, defined as eGFR <30 mL/min/1.73 m2 at screening
6. Pregnant women, those who may be pregnant, or those who are breastfeeding
7. History of autoimmune disease, history of inflammatory bowell disease, history of organ transplantation or awaiting an organ transplant, or confirmed diagnosis of malignancy within 5 years prior to screening.
8. Treatment with any medication for the indication of obesity (mazindol) within 3 months before screening
9. Treatment with incretin-related anti-diabetes drugs other than DPP-4 inhibitors, such as GLP-1R agonists (liraglutide, dulaglutide, lixisenatide, exenatide, semaglutide), GLP-1R/GIPR dual agonist (tirzepatide), within 3 months before screening
10. Treatment with alpha-glucosidase inhibitors for type 2 diabetes wihtin 3 months before screening
11. Treatment with glucocorticoid
12. Treatment with any antibiotics or antiviral drugs within 1 month before the date of fecal collection
13. Patients who are judged to be ineligible to be the subject of this trial by the investigators, e.g., patients not expected to comply with the protocol requirements or not expected to complete the trial as scheduled

Both

Type 2 diabetes

arm A (control/non-treated group): current anti-diabetes treatment will continue for 16 weeks.
arm B (tirzepatide group): tirzepatide will be administered subcutaneously (s.c.) at a starting dose of 2.5 mg/week for 4 weeks, then at a maintenance dose of 5.0 mg/week for 12 weeks.
arm C: (semaglutide group): semaglutide will be administered s.c. at a starting dose of 0.25 mg/week for 4 weeks, then at a maintenance dose of 0.5~1.0 mg/week for 12 weeks.

diabetes

D003924

Changes in the composition, gene functions and pathways of gut microbiota by metagenomic analysis at 16 week

1. Changes in the composition of gut microbiota over time (0, 4, 8, 12, 16 weeks)
2. Relationship between changes in clinical parameters (body weight, blood glucose/HbA1c, serum lipids, fatty liver index (FLI), urinary albumin-to-creatinine ratio (UACR), bone metabolism markers) and blood metabolites and changes in the composition/gene functions of gut microbiota
3. Differences in the gut microbiota composition/gene function changes between responders and non-responders for blood glucose/body weight after treatment.

+81-6-6645-3456

April. 08, 2024

Yes

Information on individual research subjects is anonymized and managed in the cloud using the electric data collection management system "REDCap." This system also performs allocation to research subjects who are judged to be eligible. This system can only be accessed by a limited number of research personnel.

none