Status:
COMPLETED
Efficacy and Safety of Premixed Insulin Treatment in Patients With Type 2 Diabetes Mellitus
Lead Sponsor:
Nanjing First Hospital, Nanjing Medical University
Collaborating Sponsors:
Wuxi Hospital of Traditional Chinese Medicine
Wuxi People's Hospital Affiliated to Nanjing Medical University
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The aim of the study is to investigate the efficacy and safety of premixed insulin treatment in patients With type 2 diabetes mellitus using professional and personal Flash Glucose Mornitoring.
Detailed Description
Professional and personal Flash Glucose Mornitoring will be used in patients with type 2 diabetes who are treated with premixed insulin. The frequency of hypogycemia and the blood glucose control will...
Eligibility Criteria
Inclusion
- participate voluntarily and sign the subject informed consent before the test.
- for patients with type 2 diabetes who met WHO1999 diagnostic criteria, subcutaneous injection with premix insulin Bid/Tid, single drug and/or combination of oral hypoglycemic drugs, the treatment regimen was stable for more than 2 months.
- no acute complications such as diabetic ketoacidosis and diabetic hyperosmolar syndrome.
- subjects are able and willing to undergo FGM examination, diet and exercise regularly.
Exclusion
- patients treated with GLP-1 agonist in the last 3 months
- patients who are allergic to insulin.
- impaired liver and renal function, ALT 2.5 times higher than the upper limit of normal value;Serum creatinine was 1.3 times higher than the upper limit of normal.
- a history of drug abuse and alcohol dependence within the past 5 years.
- used systemic hormone therapy in recent 3 months.
- patients with poor compliance and irregular diet and exercise.
- patients with infection and stress within four weeks.
- patients who cannot tolerate flash glucose mornitoring.
- patients who are pregnant, nursing or or preparing to become pregnant.
- any other apparent condition or comorption as determined by the investigator, such as severe heart and lung disease, endocrine disease, neurological disease, tumor disease, other pancreatic disease, history of mental illness.
Key Trial Info
Start Date :
October 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2021
Estimated Enrollment :
239 Patients enrolled
Trial Details
Trial ID
NCT04847219
Start Date
October 9 2019
End Date
April 30 2021
Last Update
September 27 2021
Active Locations (1)
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1
Nanjing First Hospital
Nanjing, Jiangsu, China, 210012