Efficacy and Safety of Premixed Insulin Treatment in Patients With Type 2 Diabetes Mellitus

Type 2 Diabetes Clinical Trial

Official title:

Efficacy and Safety of Premixed Insulin Treatment in Patients With Type 2 Diabetes Mellitus Observed by Different Type of Flash Glucose Mornitoring

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04847219
• Other study ID #: KY20190926-01
• Status: Completed
• Phase: N/A
• Start date: October 9, 2019
• Est. completion date: April 30, 2021

Study information

• Verified date: April 2021
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 be analyzed by flash glucose mornitoring once a month for 3 months and doctors will adjust the hypoglycemia treatment according to the results every month. HbA1c, glycemic variation, beta-cell function and androgen levels will be measured.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 239
• Est. completion date: April 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. participate voluntarily and sign the subject informed consent before the test.

2. 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.

3. no acute complications such as diabetic ketoacidosis and diabetic hyperosmolar syndrome.

4. subjects are able and willing to undergo FGM examination, diet and exercise regularly.

Exclusion Criteria:

1. patients treated with GLP-1 agonist in the last 3 months

2. patients who are allergic to insulin.

3. 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.

4. a history of drug abuse and alcohol dependence within the past 5 years.

5. used systemic hormone therapy in recent 3 months.

6. patients with poor compliance and irregular diet and exercise.

7. patients with infection and stress within four weeks.

8. patients who cannot tolerate flash glucose mornitoring.

9. patients who are pregnant, nursing or or preparing to become pregnant.

10. 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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Device:
• Professional flash glucose mornitoring
Subjects will use Professional flash glucose mornitoring once a month for 3 months.
• Personal flash glucose mornitoring
Subjects will use Personal flash glucose mornitoring once a month for 3 months.

Locations

Country	Name	City	State
China	Nanjing First Hospital	Nanjing	Jiangsu

Sponsors (5)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University	Huai'an Second People's Hospital and the Affiliated Huai'an Hospital of Xuzhou Medical University, The Affiliated Suqian First People's Hospital of Nanjing Medical University, Wuxi Hospital of Traditional Chinese Medicine, Wuxi People's Hospital Affiliated to Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TIme in range	change of TIme in range	baseline and after 3 month
Secondary	HbA1c	change of glycated hemoglobin	after 3 month
Secondary	antibody of insulin	antibody of insulin	baseline and after 3 month
Secondary	angrogen levels	angrogen levels	baseline and after 3 month
Secondary	exercise time daily	duration of exercise daily	baseline and after 3 month
Secondary	meal times	daily times of meal	baseline and after 3 month
Secondary	calorie intake	daily calorie intake	baseline and after 3 month