Type 2 diabetes
Conditions
Interventions
Trial group:Participants who met the inclusion criteria were discontinued at the time of the next dose of GLP-1 daily or GLP-1 weekly, respectively, and switched to Mazdutide 2mg once weekly, followed
Sponsors
Tianjin Medical University Chu Hsien-I Memorial Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age ranging from 18 to 70 years old (including the boundary values), regardless of gender; 2. T2DM with HbA1c levels between 6.5% and 9.0% (48 mmol/mol to 75 mmol/mol); 3. Body mass index (BMI) > 24 kg/m^2; 4. Currently receiving a stable daily or weekly formulation of a GLP-1 RA monotherapy for at least three months; 5. May concurrently use up to three antihyperglycemic agents, including metformin, a-glucosidase inhibitors, thiazolidinediones, SGLT2 inhibitors, or sulfonylureas; 6. Able to fully comprehend the study procedures and willing to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1.T1DM; 2.Individuals or family members with a history of medullary thyroid carcinoma, having type 2 multiple endocrine neoplasia, with serum calcitonin >= 50 ng/L (pg/mL), or thyroid function-related indicators such as TSH > 6 mIU/L or 3×ULN (if diagnosed with MAFLD during the screening period or within 6 months before screening, ALT 3×ULN, or total bilirubin (TBIL) > 2×ULN; 4.The eGFR estimated by CKD-EPI formula = 5.64 mmol/L (500 mg/dl), or blood amylase or lipase > 2.0×ULN; 16.A history of alcohol abuse or drug addiction; 17.A history of taking special medications (more than 2 doses per week) (such as moderate anticholinergic drugs, antiparkinsonian drugs, antiepileptic drugs, antipsychotic drugs, benzodiazepines and sedatives, morphine and narcotic analgesics, stimulant drugs, medical marijuana, cannabis and cannabidiol, etc.); 18.Insulin has been used to control diabetes within 3 months prior to screening, except for short-term use of insulin in acute states (cumulative <=14 days), such as acute diseases, during hospitalization or elective surgery. In any case, the last insulin treatment was less than 14 days before the screening date); 19.GLP-1/GIP dual glucagon receptor or GLP-1/GCG dual glucagon receptor has been used within the past 3 months ; 20.Lactating,pregnant, or having a fertility plan woman; 21.Those who have participated in other clinical studies with conflicts of interest related to this research;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change from baseline in Time In Range 3.9~10.0mmol/L at week 12; | — |
Secondary
| Measure | Time frame |
|---|---|
| The change from baseline in TBR1.0mmol/L at week 12;The change from baseline in HbA1c at week 12;The proportion of subjects achieves HbA1c <=7.0% at week 12;The change from baseline in FPG at week 12;The change from baseline in weight at week 12;The change from baseline in blood pressure at week 12;The change from baseline in blood lipid at week 12;The change from baseline in blood uric acid at week 12;The change from baseline in ALT and AST at week 12; | — |
Countries
China
Contacts
Public ContactChen Liming
Tianjin Medical University Chu Hsien-I Memorial Hospital
Outcome results
None listed