type 2 diabetes mellitus
Conditions
Interventions
Liraglutide group:Application of liraglutide 1.2-1.8mg once a day, subcutaneous injection
Control group:Do not use liraglutide, use biguanides, insulin secretagogues, aglycosidase inhibitors, dipeptidyl peptidase 4 (DPP-4) inhibitors, SGLT-2 inhibitors, basal insulin
Sponsors
Tongji Hospital, Tongji University School of Medicine
Eligibility
Sex/Gender
Female
Age
50 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Women who are 50-80 years old (including 50 and 80 years old) at the time of signing the informed consent form meet the menopausal standard (menstruation does not occur 12 months after the last menstruation over 40 years old); (2) Patients with type 2 diabetes diagnosed by the diagnostic criteria for type 2 diabetes issued by WHO (1999) at the time of screening; (3) The diagnostic criteria for osteoporosis (2017 version) were not met at the time of screening: DXA bone density T value <= -2.5, or -2.5 < T value (DXA) < -1.0+ proximal humerus, pelvis or distal forearm Fractures, or brittle fractures of the hip or vertebral body; (4) Drugs used during screening or only lifestyle intervention to control blood sugar, and all the following requirements must be met: thiazolidinedione hypoglycemic drugs should not be used for more than 2 weeks, and human insulin R had not been used within 1 month before enrollment Or short-acting insulin analogs, GLP-1 receptor agonists other than liraglutide cannot be used during the study; (5) 18.5 kg / m2 <BMI <35.0 kg / m2 during screening; (6) Daily life does not require the help of others; (7) Agree to maintain the same diet and exercise habits as the introduction period throughout the study, and follow up in time according to the study requirements; (8) Willing to sign written informed consent and abide by the research plan.
Exclusion criteria
Exclusion criteria: (1) Patients with the following diseases: major cardio-cerebrovascular history, defined as within 6 months before screening, the subject had a myocardial infarction, coronary angioplasty or bypass surgery, heart valve disease or heart valve Prosthetics, clinically significant unstable arrhythmias, unstable angina, transient ischemic attacks, cerebrovascular accidents; New York Heart Association (NYHA) grade III or IV congestive heart failure; At the time of screening, a stable dose (at least 4 weeks) of hypertension with uncontrolled antihypertensive drugs (systolic blood pressure >= 160 mmHg or diastolic blood pressure >= 100 mmHg at the time of screening); a history of unstable or rapidly progressive kidney disease; screening Active liver disease period; history of the diagnosed psychiatric disease; a history of hemoglobin disease (eg sickle cell anemia or thalassemia, ferroblastic anemia); subjects with low immunity, such as organ transplantation Or subjects diagnosed with human immunodeficiency virus infection (such as HIV); have any type of malignant tumor (whether cured or not); clinically diagnosed type 1 diabetes, Diabetes caused by pancreatic injury or other special types of diabetes. (2) Some diseases or drugs cause secondary osteoporosis; (3) The thiazolidinedione hypoglycemic agents have been used for more than 4 weeks. During the study, GLP-1 receptor agonists or human insulin R or short-acting insulin analogs other than liraglutide were required; (4) A history of drug abuse; (5) Patients usually drink > 2 units per day or > 14 units per week; 1 unit of drinking is equivalent to 150 mL of wine or 350 mL of beer or 100 mL ( 17 degrees, 24 degrees).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| all sites fractures;bone mineral density;Changes in bone turnover index;short physical performance battery; | — |
Countries
China
Contacts
Public ContactLige Song
Shanghai Tongji Hospital
Outcome results
None listed