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

NCT03631121 | Unknown Phase 4

• 1 other identifier: KY20170904-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Type2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Change of glycemic variation

  The changes of glycemic variation before and after drug change

  Day 1-13

Study Arms (1)

Basalin to Lantus

EXPERIMENTAL

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

Drug: Basalin to Lantus

Interventions

Basalin to Lantus DRUG

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

Basalin to Lantus

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with T2DM, which was defined bypublished Criteria of World Health Organization in 1999;
• 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;
• Patients had relatively constant diet and exercise in 2 month before the study.
• Fasting blood glucose\<6.1mmol/L, and postprandial (or random) blood glucose \<14mmol/L

You may not qualify if:

• 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;
• Patients with severe infectious diseases;
• Patients with acute complications of diabetes on admission, such as diabetic ketoacidosis, diabetic hyperosmolar nonketotic coma, and lactic acidosis;
• Patients with history of psychiatric disorders and were unsuitable to use CGMS;
• Any other situations that made patients unsuitable to participate in the study, such as alcoholism and drug abuse.

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Nanjing First Hostital

Nanjing, Jiangsu, 210000, China

RECRUITING

Study Officials

• Ma Jianhua

  The First Affiliated Hospital with Nanjing Medical University

  STUDY CHAIR

Central Study Contacts

Ma Jianhua

CONTACT

8625-52887092; majianhua196503@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2018
• First Posted: August 15, 2018
• Study Start: August 15, 2018
• Primary Completion: December 31, 2018
• Study Completion: July 30, 2019
• Last Updated: June 11, 2019

Record last verified: 2018-08

Locations

CN (1)