A Extension Study of Empagliflozin in Patients With Refractory Diabetes Mellitus With Insulin Resistance ( EMPIRE-02 )

Sponsor
Kobe University
Study ID
NCT04221152
Phase
PHASE3
Status
Unknown

Conditions

  • Insulin Resistance - Type A
  • Insulin Resistance - Type B
  • Insulin Resistance Syndrome
  • Lipoatrophic Diabetes Mellitus

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Empagliflozin Tablets — DRUG
    The administration is oral administration with water before or after breakfast.

Study Details

A multicenter, open-label, single-arm, extension study with regard to the safety and efficacy of empagliflozin in patients with refractory diabetes mellitus with insulin resistance.

Key Dates

Start date
Feb 1, 2020
Status verified
Jun 2021
Primary completion
Feb 1, 2022
Completion
May 31, 2022

Study Design

Enrollment
8 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment of empagliflozin
    The study treatment shall be started from the next day of the Week 24 visit of the EMPIRE-01 study after enrollment. The investigational drug shall be administered at the same dosage as that of the empagliflozin tablet administered from Week 12 to Week 24 of the treatment period in the EMPIRE-01 study. The administration is oral administration with water once daily before or after breakfast.

Primary Outcome Measure

Adverse events, Adverse drug reactions, and Presence/absence of the use of rescue treatment drugs [ Time Frame: until Week 28 (Week 52 of the EMPIRE-01 study) ]

Related Studies