Empagliflozin in Post-Transplantation Diabetes Mellitus

Phase 1

• Conditions: Post-Transplant Diabetes Mellitus; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2016-001580-37-AT
• Lead Sponsor: Medical University of Vienna

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-21
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Diagnosed PTDM defined as:
2 hour plasma glucose level = 200 mg/dL in the OGTT (75mg glucose), twice blood glucose levels = 200 mg/dL during random controls or twice fasting glucose levels = 125 mg/dL or HbA1c = 6.5%
Stable graft function for more than 6 months post transplantation (eGFR = 30 ml/min)
At least 6 months of basal insulin therapy for PTDM
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

Exclusion Criteria

Age< 18 years
Patients with prior history of type 1 or type 2 diabetes
Pregnancy
Severe renal impairment (GFR < 30 mL/min./1.73 m2)
Severe blood glucose elevation with the need for therapy with insulin > 40 IE/day or HbA1c >8.5%.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified