Effect of Akkermansia Muciniphila WST01 Strain in Overweight or Obese Patients With Type 2 Diabetes

• Status: Recruiting
• Trial end date: 2022-10-30
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to conduct a randomized, double-blinded, placebo-controlled, multicenter clinical trial, evaluating the glucose-lowering and weight-loss effects of Akkermansia muciniphila WST01 strain in overweight or obese patients with Type 2 Diabetes.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

Criteria

Main Inclusion Criteria:

1. Subjects with type 2 diabetes mellitus;

2. Age 18-60 years;

3. Overweight / obesity (24.0 ≤ BMI ≤ 40.0 kg/m2)；

4. Subjects with or without other obesity related metabolic complications (hypertension, dyslipidemia, hyperuricemia, etc.);

5. Subjects with screening HbA1c ≥ 7.0% and ≤ 10.0%, and the fasting blood glucose ≥ 7.0 mmol/l and ≤ 13.3 mmol/l；

6. Subjects who are not taking any medications to control blood glucose;

7. Subjects control blood glucose only by lifestyle intervention (diet and exercise) for at least 2 months before the screening period;

8. Subjects understand the nature, significance, potential benefits, inconvenience, and risks of the study before it starts；

9. Subjects fully understand the study produces and voluntarily sign the informed consent form.

Main Exclusion Criteria:

1. Subjects with a history of taking hypoglycemic drugs;

2. Subjects who are pregnant or in lactation;

3. Subjects with type 1 diabetes, single gene mutation diabetes, diabetes due to pancreatic injury or other secondary diabetes (such as Cushing's syndrome, thyroid dysfunction or acromegaly, etc.);

4. Subjects who were or are using oral hypoglycemic agents or insulin or incretin to control diabetes;

5. Subjects with liver and kidney dysfunction (alanine transaminase(ALT) / aspartate aminotransferase(AST)≥2.5×the upper limit of normal(ULN) set by the hospital, serum creatinine>1×ULN set by the hospital, or eGFR<60mL/min/1.73m2);

6. Surgery with serious cardiovascular and cerebrovascular diseases (such as heart failure, myocardial infarction, cerebral infarction, acute myocarditis, severe arrhythmia, patients receiving interventional therapy, etc.) or stage III hypertension (systolic blood pressure cannot be controlled below 160 mmHg with three antihypertensive drugs);

7. Subjects with acute diabetic complications such as diabetic ketoacidosis or diabetic hyperosmolar coma in the past 3 months;

8. Subjects with a medical history of malignant tumor (except local skin basal cell carcinoma) in the past 5 years;

9. Subjects with a medical history of intestine, or other digestive tract surgery (such as cholecystectomy) within one year, or other non-gastrointestinal surgery within 6 months;

10. Any condition that in the judgement of the investigator precludes participation.

Details please see the study protocol.