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

NCT ID: NCT03631121

Last Updated: 2019-06-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-15
• Study Completion Date: 2019-07-30

Brief 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.

Detailed 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.

Conditions

Type2 Diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Basalin to Lantus

the patients who are using Basalin treatment will use isodose of Lantus instead

Group Type: EXPERIMENTAL

Basalin to Lantus

Intervention Type: DRUG

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

Interventions

Basalin to Lantus

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing First Hospital, Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ma Jianhua

Role: STUDY_CHAIR

The First Affiliated Hospital with Nanjing Medical University

Locations

Nanjing First Hostital

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ma Jianhua

Role: CONTACT

majianhua196503@126.com

8625-52887092

Facility Contacts

Jianhua Ma, Doctor

Role: primary

majianhua196503@126.com

+8618951670116

Other Identifiers

KY20170904-01

Identifier Type: -

Identifier Source: org_study_id