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

NCT03631134 | Unknown Phase 4

• 1 other identifier: KY20170904-02
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Changes of glycemic variation

  Changes of glycemic variation assessed by CGM before and after SGLT2 inhibitor adding

  Week 1-5

Secondary Outcomes (1)

• Change of insulin dose

  Week 1-5

Study Arms (1)

SGLT2i treatment

EXPERIMENTAL

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

Drug: SGLT2 inhibitor

Interventions

SGLT2 inhibitor DRUG

Patients will be gave SGLT2 inhibitor 10mg per day

SGLT2i treatment

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 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;
• Patients had relatively constant diet and exercise in 2 month before the study.
• Fasting blood glucose was between 6.1 and 16mmolL, and postprandial (or random) blood glucose \<22.2mmol/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;
• Patients used GLP-1 analogues，SGLT2 or more than once insulin injection in the past 3 months
• 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

MeSH Terms

Interventions

Sodium-Glucose Transporter 2 Inhibitors

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs

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: January 15, 2019
• Study Completion: January 30, 2019
• Last Updated: August 15, 2018

Record last verified: 2018-08