Type 2 Diabetes mellitus
Conditions
Interventions
control group:A dose of 0.50 mg semaglutide injected subcutaneously (under the skin) once weekly
Experimental group:A dose of 0.50 mg semaglutideinjected subcutaneously (under the skin) once weekly and Xiang-Sha-Liu-Jun-Zi tang
Sponsors
Hospital of Chengdu University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1)aged 18-70 years (both inclusive). (2)Diagnosed with type 2 diabetes. (3)Patients who have Gastrointestinal Adverse Reactions and Diagnosed with Spleen-deficiency syndrome during the run-in period. (4)Body mass index (BMI) greater than or equal to 25.0 kg/sqm. (5)HbA1c of 7.0-10.0% ( both inclusive). (6)Participants who have been taking other hypoglycemic drugs, such as insulin, oral hypoglycemic drugsrequires stable treatment for at least 3 months before screening. (7)Intend to use Semaglutide. (8)Signed the informed consent form.
Exclusion criteria
Exclusion criteria: (1)History of type 1 diabetes,Secondary diabetes,gestational diabetes,Female who is pregnant,breast-feeding. (2)Have had acute complications of diabetes in the past 3 months,such as ketoacidosis,lactic acidosis,hyperosmolar coma and other critical illnesses. (3)concomitant with other systemic diseases such as severe impaired renal function(estimated glomerular filtration rate [eGFR] <45 mL/min/1.73 m2), heart failure (New York Heart Association Class IV) or any acute coronary or cerebrovascular event within 90 days before randomization. (4)Patients who are in a state of stress or severely infected. (5)History of pancreatitis (acute or chronic). (6)Family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma. (7)History of Diabetic gastrointestinal disease (for example Esophageal syndrome, diabetic gastroparesis,Diabetes mellitus with diarrhea or constipation). (8)Have had obvious digestive symptoms in the past 1 month,such as: nausea, vomiting, bloating, diarrhea, constipation (including adverse drug reactions, caused by diseases). (9)Have been or are being treated with a other glucagon-like peptide-1 receptor agonists or Dipeptidyl peptidase 4 (DPP-4) inhibitors in the past. (10)Evaluation of the nodules according to TI-RADS,patients were found to be in the TI-RADS 3 categories and above. (11)There was no gastrointestinal reaction ,or have gastrointestinal reactions but did not meet the Spleen-deficiency syndrome within 2 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gastrointestinal Symptom-Rating Scale ;the duration of individual gastrointestinal adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| HOMA2-IR;coefficient of variation;mean blood glucose;body weight;Fasting Plasma C-peptide;estimated HbA1c;fasting plasma glucose;Glucagon;time in range;mean amplitude of glycemic excursions;glycated serum protein;Hip circumference;The TCM symptom score system;Low density lipoprotein cholesterol;inter-quartile range;2-hour postprandial blood glucose;High density liptein cholesterol;waist circumference;HOMA2-%B;body mass index;Large amplitude of glycemic excursions;The standard deviation of blood glucose values;triglyceride;Waist-to-hip ratio;mean of daily differences;total cholesterol; | — |
Countries
China
Contacts
Public ContactChen Qiu
Outcome results
None listed