Actively Recruiting
Effects of Tirzepatide and Insulin Glargine on Glucolipid Metabolism and Brain Function in Patients With Type 2 Diabetes
Led by Nanjing First Hospital, Nanjing Medical University · Updated on 2022-09-23
150
Participants Needed
1
Research Sites
293 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The effects of Tirzepatide and Insulin Glargine on glucose and lipid metabolism and inflammation in patients with type 2 diabetes mellitus. Effects of Tirzepatide on the occurrence and development of cognitive impairment in diabetic patients and its associated pattern of changes in brain neural network characteristics.
CONDITIONS
Official Title
Effects of Tirzepatide and Insulin Glargine on Glucolipid Metabolism and Brain Function in Patients With Type 2 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Type 2 diabetes diagnosed according to WHO or local criteria
- Stable treatment with metformin with or without sulfonylureas for at least 2 months before visit 1
- No insulin treatment except for gestational diabetes or short-term use (≤14 days)
- HbA1c between 7.5% and 11.0% at visit 1
- Body mass index (BMI) of at least 23 kg/m2
You will not qualify if you...
- Diagnosis of type 1 diabetes mellitus
- History of chronic or acute pancreatitis
- Proliferative diabetic retinopathy, diabetic macular degeneration, or non-proliferative diabetic retinopathy needing acute treatment
- Severe or insensitive hypoglycemia within 6 months prior to visit 1
- History of ketoacidosis or hyperosmolar state/coma
- Significant gastric emptying disorder or planned gastric surgery during the study
- Cardiovascular events (heart attack, stroke, heart failure hospitalization) within 2 months before visit 1
- New York Heart Association Class III or IV heart failure
- Acute or chronic hepatitis or liver disease other than NAFLD with ALT >3 times normal
- Estimated glomerular filtration rate (eGFR) less than 45 mL/min/1.73 m2
- Significant endocrine disorders like thyrotoxicosis or adrenal crisis
- Family or personal history of medullary thyroid cancer or type 2 multiple endocrine tumor syndrome
- Serum calcitonin level ≥35 ng/L at visit 1
- Active autoimmune diseases requiring systemic glucocorticoid therapy in next 12 months
- Previous organ transplant or awaiting transplant (except corneal)
- Active or untreated cancer or remission less than 5 years for significant malignancy
- Any medical history preventing study compliance
- Blood disorders interfering with HbA1c measurement such as hemolytic anemia or sickle cell disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Nanjing First Hospital
Nanjing, Jiangsu, China, 210006
Actively Recruiting
Research Team
J
Jianhua Ma, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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