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

Phase 4

• Conditions: Type2 Diabetes
• Interventions: Drug: Basalin to Lantus

• Registration Number: NCT03631121
• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

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.

Study Timeline

• Status Verified: 2018-08
• Study First Submitted: 2018-08-12
• Study First Submitted QC: 2018-08-12
• Study Start: 2018-08-15
• Study First Posted: 2018-08-15
• Primary Completion: 2018-12-31
• Last Update Submitted: 2019-06-09
• Last Update Posted: 2019-06-11
• Study Completion: 2019-07-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Basalin to Lantus	Basalin to Lantus	the patients who are using Basalin treatment will use isodose of Lantus instead

Primary Outcome Measures

Name	Time	Method
Change of glycemic variation	Day 1-13	The changes of glycemic variation before and after drug change

Trial Locations

Locations (1)

Nanjing First Hostital; 🇨🇳 Nanjing, Jiangsu, China