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

Phase 4

• Conditions: Type2 Diabetes
• Interventions: Drug: SGLT2 inhibitor

• Registration Number: NCT03631134
• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-08
• Study First Submitted: 2018-08-12
• Study First Submitted QC: 2018-08-12
• Last Update Submitted: 2018-08-12
• Study Start: 2018-08-15
• Study First Posted: 2018-08-15
• Last Update Posted: 2018-08-15
• Primary Completion: 2019-01-15
• Study Completion: 2019-01-30

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 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SGLT2i treatment	SGLT2 inhibitor	The patients who are using basal insulin therapy with or without oral hypoglycemic drugs will be added SGLT2 inhibitor treatment

Primary Outcome Measures

Name	Time	Method
Changes of glycemic variation	Week 1-5	Changes of glycemic variation assessed by CGM before and after SGLT2 inhibitor adding

Secondary Outcome Measures

Name	Time	Method
Change of insulin dose	Week 1-5	Change of insulin dose before and after SGLT2 inhibitor adding