type 2 diabetes
Conditions
Interventions
Recombinant anti human GLP-1 receptor humanized monoclonal antibody injection group:This study is a randomized controlled clinical study. Patients with type 2 diabetes who were poorly treated with met
placebo:This study is a randomized controlled clinical study. Patients with type 2 diabetes who were poorly treated with metformin were selected. The treatment was divided into 24 weeks in the first s
Sponsors
Nanjing First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Men or women who are = 18 years old and = 75 years old when signing the informed consent form; 2) Subjects with type 2 diabetes who meet the diagnostic criteria for diabetes issued by the World Health Organization (WHO) in 1999; 3) Has received stable treatment with metformin for at least 8 weeks before screening (= 1500mg/day or maximum tolerable dose = 1000mg/day); 4) During screening, HbAlc = 7.5% and = 10.5% (local laboratory), and at random, HbAlc = 7.0% and = 10.5%; 5) During screening, FPG = 13.9mmol/L (local laboratory), and before randomization, FPG = 13.9mmol/L (central laboratory); 6) Body mass index (BMI) = 19.0 kg/m2 and<35.0 kg/m2 during screening; 7) Willing to follow the research protocol requirements for dietary and exercise interventions throughout the entire research process; Willing to use experimental drugs according to the research protocol requirements, conduct self monitoring of blood glucose (SMBG) in a timely manner, and keep records; 8) Able to understand and willing to sign a written informed consent form and comply with the research protocol.
Exclusion criteria
Exclusion criteria: 1) Known or suspected allergy to GLP-1 analogues or related drugs, or allergic constitution (allergic to = Class 2 substances, including all contact, inhalation, and ingestion allergens); 2) Clinically diagnosed type 1 diabetes, diabetes caused by pancreatic injury or other special types of diabetes; 3) Any anti diabetes drugs other than metformin were used within 8 weeks before screening; 4) Previously used any DPP-4 inhibitor or GLP-1 analogue with poor safety or efficacy; 5) Received insulin treatment for more than 14 consecutive days within 6 months prior to screening; 6) Screening for spatiotemporal C-peptide450 mL) or receiving blood transfusion before randomization; 17) Serious injuries, infections, or surgeries that may affect blood sugar control have occurred within one month prior to screening and before randomization; 18) Any unstable or treatable endocrine system disease related to blood sugar (such as hyperthyroidism, acromegaly syndrome, Cushing's syndrome), judged by the researcher as unsuitable for participation in the study; 19) Having used drugs with weight control effects or undergone surgery that can cause weight instability within the first 2 months of screening, or currently in the weight loss plan and not in the maintenance stage; 20) Clinically significant gastric emptying abnormalities (such as gastric outlet obstruction), severe chronic gastrointestinal diseases (such as active ulcers occurring within 6 months), long-term use of drugs that have a direct impact on gastrointestinal peristalsis, or receiving stomach medication Intestinal surgery (excluding gastrointestinal endoscopic surgery that has been det
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dynamic blood glucose monitoring; | — |
Secondary
| Measure | Time frame |
|---|---|
| bone density; | — |
Countries
China
Contacts
Public ContactMa Jianhua
Nanjing First Hospital
Outcome results
None listed