diabetes
Conditions
Interventions
Group 2:metformin hydrochloride tablets
Group 3:metformin hydrochloride sustained-release tablets (III)
Sponsors
Department of Endocrinoly, Peking University First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) People met the diagnostic criteria for Guideline for the prevention and treaent of type 2 diabetes mellitus in China (2020 edition), newly diagnosed with type 2 diabetes, and no previous use of hypoglycemic drugs; 2) Adult males and nonpregnant non-lactating females aged 18-80 years old (including boundary values); 3) Glycosylated hemoglobin HbA1c: > 6.5%, = 9%; 4) Sign informed consent before the trial, fully understand the trial content, process and possible adverse reactions, and be able to communicate well with researchers.
Exclusion criteria
Exclusion criteria: 1) Diagnosed with type 1 diabetes; 2) Used other hypoglycemic drugs in the last 8 weeks before the trial; 3) Use of any psychotropic drugs or drugs deemed unsuitable by the investigator within 14 days prior to the trial; 4) Severe renal failure, eGFR<60ml/min/1.73m2; 5) Diseases that cause tissue hypoxia (especially exacerbations of acute or chronic diseases), such as decompensated heart failure, respiratory failure, recent myocardial infarction and shock; 6) Severe infection, trauma, major surgery, clinical hypotension and hypoxia; 7) Liver insufficiency, acute alcoholism, alcoholism; 8) People whose vitamin B12, folic acid deficiency is difficult to correct; 9) Have participated in any clinical trial within 90 days prior to the trial or plan to participate in other clinical trials during the trial; 10) Blood loss or blood donation of more than 300mL (excluding female menstrual blood loss) within 90 days before the trial, or received blood transfusion; 11) Esophageal reflux, gastric bleeding, or peptic ulcer disease in the 180 days prior to the trial, heartburn more than once a week, or any surgical procedure (such as cholecystectomy) that may interfere with drug absorption; 12) Have a history of specific allergies (asthma, urticaria, eczema, etc.), or atopy (such as allergies to two or more drugs, foods or pollen), or are known to be allergic to components or analogizes of this drug; 13) Subjects with partners refuse to use effective contraception for 180 days from screening to completion of the trial. The pregnancy test of female subject was positive. 14) With diseases that may lead to tissue hypoxia (particularly acute or worsening of chronic diseases), with acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma; 15) Subjects may not be able to complete the trial for other reasons or be deemed by the investigator to be unsuitable for the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of hemoglobin a1c (HbA1c) from baseline to 24 weeks after treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change of hemoglobin a1c (HbA1c) from baseline to 12 weeks after treatment;Changes of fasting plasma glucose (FPG) from baseline to 2 weeks, 4 weeks, 12 weeks and 24 weeks after treatment;Changes of body weight and waist circumference from baseline at each post-treatment visit;Gastrointestinal adverse reactions; | — |
Countries
China
Contacts
Public ContactJunqing Zhang
Department of Endocrinoly, Peking University First Hospital
Outcome results
None listed