Effect of SGLT2 Inhibitor on Blood Glucose Profile in Type 2 Diabetic Patients Using Basal Insulin

Type2 Diabetes Clinical Trial

Official title:

Effect of SGLT2 Inhibitor on Blood Glucose Profile in Type 2 Diabetic Patients Using Basal

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03631134
• Other study ID #: KY20170904-02
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: August 15, 2018
• Est. completion date: January 30, 2019

Study information

• Verified date: August 2018
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The change of glycemic variation and insulin dose after adding SGLT2 inhibitor in type 2 diabetic patients treated with basal insulin was observed in a single center.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: January 30, 2019
• Est. primary completion date: January 15, 2019
• 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 glargine with or without oral hypoglycemic drugs and having a stable dose of glargine for more than 2 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 was between 6.1 and 16mmolL, and postprandial (or random) blood glucose <22.2mmol/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. Patients used GLP-1 analogues,SGLT2 or more than once insulin injection in the past 3 months

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

Related Conditions & MeSH terms

• Type2 Diabetes

Intervention

Drug:
• SGLT2 inhibitor
Patients will be gave SGLT2 inhibitor 10mg per day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of glycemic variation	Changes of glycemic variation assessed by CGM before and after SGLT2 inhibitor adding	Week 1-5
Secondary	Change of insulin dose	Change of insulin dose before and after SGLT2 inhibitor adding	Week 1-5