Efficacy and Safety of Basal-Bolus Insulin Therapy with SGLT2 Inhibitors in Patients with Type 2 Diabetes Mellitus Hospitalized for Hyperglycemia

Evaluation of the Efficacy and Safety of Basal-Bolus Insulin Therapy combined SGLT2 Inhibitors in Patients with Type 2 Diabetes Mellitus Hospitalized for Hyperglycemia; An open-label prospective randomized trial - Efficacy and Safety of Basal-Bolus Insulin Therapy with SGLT2 Inhibitors in Patients with Type 2 Diabetes Mellitus Hospitalized

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000053224

Enrollment

Registered

2023-12-26

Start date

2023-12-26

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Type 2 diabetes

Interventions

Basal-bolus insulin therapy with empagliflozin 10mg Basal-bolus insulin therapy alone

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Untreated patients with an HbA1c > 10% 2) Patients on oral diabetes medications with HbA1c > 8% 3) On once-daily insulin self-injection or once-daily GLP-1 receptor agonist and HbA1c > 8% 3) BMI>18kg/m2 4) Hospitalization for the primary purpose of glycemic control 5) Patients with consent obtained

Exclusion criteria

Exclusion criteria: 1) Type 1 diabetes mellitus 2) Frequent insulin injections 3) Pregnancy 4) On SGLT2 inhibitors (washout for at least 1 week is acceptable) 5) DPP4 inhibitor in once-weekly formulation 6) Once-weekly GLP-1RA 7) Undergoing chemotherapy 8) DKA or history of DKA 9) Hyperglycemic coma 10)High-dose steroids (>10 mg PSL equivalent)

Design outcomes

Primary

Measure	Time frame
Percentage of blood glucose 70-180 mg/dl based on continuous blood glucose measurements for 8 days after admission	—

Secondary

Measure	Time frame
1) Blood glucose levels measured before each meal + before bedtime 2) Blood glucose variability data by CGM 3) Blood ketone levels 4) Frequency of hypoglycemia 5) Length of hospitalization	—

Countries

Japan

Contacts

Public ContactTakashi Terada

Ichinomiyanishi Hospital Operations Division

n-terada@anzu.or.jp0586480077

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026