Skip to content

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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03631134
Enrollment
100
Registered
2018-08-15
Start date
2018-08-15
Completion date
2019-01-30
Last updated
2018-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type2 Diabetes

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.

Interventions

DRUGSGLT2 inhibitor

Patients will be gave SGLT2 inhibitor 10mg per day

Sponsors

Nanjing First Hospital, Nanjing Medical University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Changes of glycemic variationWeek 1-5Changes of glycemic variation assessed by CGM before and after SGLT2 inhibitor adding

Secondary

MeasureTime frameDescription
Change of insulin doseWeek 1-5Change of insulin dose before and after SGLT2 inhibitor adding

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026