Study design and participants
chronic gastrointestinal dysfunction, allergic, flatulence, unstable angina pectoris, neurological disorders, alcoholism, hernia, Cushing’s syndrome, ’s syndrome, hypoglycemic, substance addictions, acromegaly, T2DM, diabetes
INTESTINAL ULCERS, UNSTABLE ANGINA PECTORIS, INTESTINAL OBSTRUCTION, NEUROLOGICAL DISORDERS, DISORDERS, TYPE 1 DIABETES MELLITUS, HYPERTHYROIDISM, ENDOCRINE DISEASES, HEART DISEASES, DIABETIC COMPLICATIONS, ACROMEGALY, DISEASES, SECONDARY DIABETES MELLITUS, DIABETES
This was a 12-week open-label, randomized, parallel-controlled, clinical trial. We enrolled patients with T2DM who had poorly controlled blood glucose levels when using oral hypoglycemic agents, and had been hospitalized in the Department of Endocrinology and Metabolism of the First Affiliated Hospital of Harbin Medical University between June 2022 and March 2023.The inclusion criteria were patients who: 1) were aged 18–70 years old, regardless of sex; 2) had body mass index(BMI) between 19 kg/mThe exclusion criteria were patients who: 1) were allergic or intolerant to α-glucosidase inhibitors, or for whom these drugs had been proven to be ineffective; 2) had severe diabetic complications; 3) had secondary diabetes mellitus, specific types of diabetes, and type 1 diabetes mellitus; 4) had chronic gastrointestinal dysfunction, obvious digestive and absorption disorders, as well as other endocrine diseases, such as hyperthyroidism, Cushing’s syndrome,or acromegaly, etc; 5) had diseases that could be worsened by flatulence (such as Roeheld’s syndrome, severe hernia, intestinal obstruction, following gastrointestinal surgery and intestinal ulcers); 6) had unstable angina pectoris within 6 months prior to the study, had serious heart diseases, or were likely to die during the treatment and follow-up period; 7) had mental and neurological disorders who could not clearly express themselves; 8) were suffering from alcoholism or other substance addictions; 9) were women of childbearing age who were pregnant, lactating, had a positive pregnancy test (urine or blood HCG), intended to become pregnant over the study and follow-up period, or could not take effective contraceptive measures during the study and follow-up period (including measures such as sterilization, intrauterine devices, and oral contraceptives); 10) had participated in clinical trials of other drugs or medical devices in the three months preceding the study’s start date.This study was approved by the Ethics Review Committee of the First Affiliated Hospital of Harbin Medical University (Harbin, China). All participants provided written informed consent prior to registration. All experiments were conducted in accordance with the principles of the Declaration of Helsinki.