Back to resultsEffects of Replacing Lantus With Basalin on the Glycemic Variation in Patients With Type 2 Diabetes Mellitus
Primary Purpose
Type2 Diabetes
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Basalin to Lantus
Sponsored by
About this trial
This is an interventional treatment trial for Type2 Diabetes
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
- Nanjing First HostitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Basalin to Lantus
Arm Description
the patients who are using Basalin treatment will use isodose of Lantus instead
Outcomes
Primary Outcome Measures
Change of glycemic variation
The changes of glycemic variation before and after drug change
Secondary Outcome Measures
Full Information
NCT ID
NCT03631121
First Posted
August 12, 2018
Last Updated
June 9, 2019
Sponsor
Nanjing First Hospital, Nanjing Medical University
1. Study Identification
Unique Protocol Identification Number
NCT03631121
Brief Title
Effects of Replacing Lantus With Basalin on the Glycemic Variation in Patients With Type 2 Diabetes Mellitus
Official Title
Effects of Replacing Lantus With Basalin on the Glycemic Variation in Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 15, 2018 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
July 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nanjing First Hospital, Nanjing Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type2 Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Basalin to Lantus
Arm Type
Experimental
Arm Description
the patients who are using Basalin treatment will use isodose of Lantus instead
Intervention Type
Drug
Intervention Name(s)
Basalin to Lantus
Intervention Description
continuous glucose monitoring system will used twice when patients are using Basalin and Lantus respectively to assess glycemic variation.
Primary Outcome Measure Information:
Title
Change of glycemic variation
Description
The changes of glycemic variation before and after drug change
Time Frame
Day 1-13
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ma Jianhua
Phone
8625-52887092
Email
majianhua196503@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ma Jianhua
Organizational Affiliation
The First Affiliated Hospital with Nanjing Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Nanjing First Hostital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianhua Ma, Doctor
Phone
+8618951670116
Email
majianhua196503@126.com
12. IPD Sharing Statement
Learn more about this trial
Effects of Replacing Lantus With Basalin on the Glycemic Variation in Patients With Type 2 Diabetes Mellitus
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