Type 2 Diabetes
Conditions
Interventions
Metformin gastrointestinal adverse effects in T2DM patients:NA
Metformin without gastrointestinal adverse effects in T2DM patients:NA
Sponsors
Beijing Friendship Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Voluntary participation and signed informed consent, able to understand and willing to comply with the requirements of the study protocol to complete the study; 2)Men and women aged =18 and =75 years; 3)Patients diagnosed with type 2 diabetes mellitus according to the diagnostic criteria for diabetes mellitus promulgated by the World Health Organization (WHO) in 1999; 4) Satisfied at screening: ?Treated with metformin monotherapy with =1000 mg of metformin daily for =8 weeks and discontinued metformin due to gastrointestinal discomfort. (ii) HbA1C >7%, but gastrointestinal adverse effects while taking >500 mg (patients who fulfill either of these two conditions are metformin intolerant). Or patients taking =2000 mg of metformin per day for more than one year (excluding metformin extended-release formulations) without adverse reactions (metformin-tolerant patients). 5)Body mass index BMI =18.5 kg/m2 and =35 kg/m2; 6)No use of microecological agents or antibiotics within 4 weeks prior to enrollment;
Exclusion criteria
Exclusion criteria: 1) Non-type 2 diabetes: type 1 diabetes, gestational diabetes, or other specialized types of diabetes; 2)Patients with severe diabetic complications; 3)Those who have used drugs other than metformin that may affect glucose metabolism, such as other types of hypoglycemic agents, systemic glucocorticosteroids (except for inhalation or topical topical use), and growth hormone within 8 weeks prior to screening; 4)Use of insulin for more than 14 consecutive days within 1 year prior to screening (the time of receiving insulin therapy for gestational diabetes mellitus is not included in this limit); 5) Those who have been treated with any dipeptidyl peptidase 4 (DPP-4) inhibitor or glucose-dependent insulinotropic polypeptide (GIP) or/and glucagon-like peptide-1 (GLP-1) receptor agonist prior to screening; 6)Pregnancy or lactation; 7)Congestive heart failure class III or IV as defined by the New York Heart Association (NYHA); 8)Persons with a history of significant cardiovascular or cerebrovascular disease, defined as myocardial infarction, coronary artery vascular bypass grafting or angioplasty, heart valve disease or repair, unstable angina pectoris, transient ischemic attack, or cerebral vascular accident, within the 6 months prior to screening; 9)Malignant tumor (except cured basal cell carcinoma) within 5 years prior to screening; 10)lower limb edema or generalized edema; 11)Moderate to severe renal insufficiency (eGFR 300 mg/g; 13)Triglyceride value >5.6 mmol/L; 14)active liver disease and/or significant liver function abnormality, with significant liver function abnormality defined as alanine aminotransferase (ALT) > 2.5 times the upper limit of normal and/or aspartate aminotransferase (AST) > 2.5 times the upper limit of normal and/or total bilirubin > 1.5 times the upper limit of normal; 15)The presence of clinically significant arrhythmia on ECG and the need for treatment or intervention that, in the judgment of an investigator, makes participation in this clinical trial unsuitable; 16)Those who are positive for human immunodeficiency virus (HIV) antibodies; those who are positive for antibodies against spirochetes of syphilis; those who are positive for surface antigen of hepatitis B and have a quantitative HBV DNA test value higher than the upper limit; those who are positive for antibodies against hepatitis C and have a quantitative HCV RNA test value higher than the upper limit; 17)History of illicit drug abuse within 12 months prior to screening; 18)Participation in another clinical trial within 90 days prior to screening; 19) have donated whole blood, plasma or platelets within 3 months prior to screening; 20) who, in the opinion of the investigator, are not suitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gastrointestinal Adverse Reactions;intestinal flora;HbA1c; | — |
Secondary
| Measure | Time frame |
|---|---|
| routine blood test;urinalysis;Liver and kidney function;Metabolites (such as bile acids); | — |
Countries
China
Contacts
Public ContactYan Dan
Beijing Friendship Hospital, Capital Medical University
Outcome results
None listed