A Study of Empagliflozin in Patients With Refractory Diabetes Mellitus With Insulin Resistance

Sponsor
Kobe University
Study ID
NCT04018365
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 study with regard to the efficacy and safety of empagliflozin in patients with refractory diabetes mellitus with insulin resistance

Key Dates

Start date
Sep 1, 2019
Status verified
Mar 2021
Primary completion
Jul 31, 2021
Completion
Oct 30, 2021

Study Design

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

Arms

  • Experimental: Treatment of empagliflozin
    Empagliflozin 10 mg is to be continuously administered once daily for 12 weeks. Measure an HbA1c level after 12 weeks and determine the dose (Week 13 to Week 24). In case of \<7.0%, 10 mg will be continued: in case of \>=7.0%, it will be increased to 25 mg.

Primary Outcome Measure

HbA1c change at Week 24 of the treatment from baseline [ Time Frame: at Week 24 of the treatment from baseline ]

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