Effects of Replacing Lantus With Basalin on the Glycemic Variation in Patients With Type 2 Diabetes Mellitus

Type2 Diabetes Clinical Trial

Official title:

Effects of Replacing Lantus With Basalin on the Glycemic Variation in Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03631121
• Other study ID #: KY20170904-01
• Status: Recruiting
• Phase: Phase 4
• Start date: August 15, 2018
• Est. completion date: July 30, 2019

Study information

• Verified date: August 2018
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: Ma Jianhua
• Phone: 8625-52887092
• Email: majianhua196503[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study will assess the glycemic variationusing continuous glucose monitoring system in type 2 diabetic patients with euglycemia control respectively when patients was treated with Basalin and one week after changing the insulin into Lantus.

Description:

The participants will take continuous glucose monitoring system for 3 days when they change the insulin into Lantus after reach euglycemia control with Basalin treatment for one week.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 30, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Patients with T2DM, which was defined bypublished Criteria of World Health Organization in 1999;

2. Patients were using Basalin with or without oral hypoglycemic drugs and having a stable dose of glargine for more than 3 month would be recruited into this study;

3. Patients had relatively constant diet and exercise in 2 month before the study.

4. Fasting blood glucose<6.1mmol/L, and postprandial (or random) blood glucose <14mmol/L

Exclusion Criteria:

1. Patients with severe cardiovascular diseases, such as stroke, transient ischemic attack, myocardial infarction, unstable angina, coronary artery bypass grafting, percutaneous coronary intervention, and heart failure;

2. Patients with severe infectious diseases;

3. Patients with acute complications of diabetes on admission, such as diabetic ketoacidosis, diabetic hyperosmolar nonketotic coma, and lactic acidosis;

4. Patients with history of psychiatric disorders and were unsuitable to use CGMS;

5. Any other situations that made patients unsuitable to participate in the study, such as alcoholism and drug abuse.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type2 Diabetes

Intervention

Drug:
• Basalin to Lantus
continuous glucose monitoring system will used twice when patients are using Basalin and Lantus respectively to assess glycemic variation.

Locations

Country	Name	City	State
China	Nanjing First Hostital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of glycemic variation	The changes of glycemic variation before and after drug change	Day 1-13