NCT03157414

Brief Summary

This is a single-center, prospective, controlled, double-blind, randomized study. A total of 50 renal transplant recipients diagnosed with post-transplantation diabetes mellitus (PTDM) will be included more than 1 year after transplantation and randomized 1:1 to empagliflozin (Jardiance®) 10 mg or placebo once daily for 24 weeks. Patients with estimated glomerular filtration rate below 30 mL/min will be excluded. Oral glucose tolerance test, 72h continuous glucose monitoring (iPro™2), measurement of arterial stiffness, body composition (including visceral fat), 24h blood pressure and 24h urinary glucose excretion will be performed at baseline and after 24 weeks in addition to standard safety measurements. Two safety visits will be performed at week 8 and 16. All concomitant medication, diet and exercise will be kept stable during the study period. The objective of the present study is to answer whether empagliflozin safely and effectively improves glucose metabolism together with weight loss in renal transplant recipients with PTDM.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for phase_4 diabetes-mellitus

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 7, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 15, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 17, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2018

Completed
Last Updated

March 15, 2019

Status Verified

March 1, 2019

Enrollment Period

1.6 years

First QC Date

March 15, 2017

Last Update Submit

March 13, 2019

Conditions

Diabetes MellitusRenal InsufficiencySafety Issues

Outcome Measures

Primary Outcomes (1)

  • Weighted mean glucose

    The primary endpoint will be change from baseline in weighted mean glucose at week 24 compared to placebo. Each patient will perform continuous plasma glucose monitoring (CGM, iProTM2) for 72 hours at baseline and after 24 weeks.

    24 weeks

Secondary Outcomes (10)

  • Fasting plasma glucose

    24 weeks

  • 2 hour glucose concentration

    24 weeks

  • Glycated hemoglobin (HbA1c)

    24 weeks

  • Body weight

    24 weeks

  • Waist-hip-ratio

    24 weeks

  • +5 more secondary outcomes

Other Outcomes (3)

  • Incidence of abnormal trough levels of immunosuppressive drugs

    24 weeks

  • Adverse event

    24 weeks

  • Urinary glucose excretion

    24 weeks

Study Arms (2)

Empagliflozin

ACTIVE COMPARATOR

10 mg once daily for 24 weeks

Drug: Empagliflozin

Placebo

PLACEBO COMPARATOR

1 capsule once daily for 24 weeks

Other: Placebo

Interventions

EmpagliflozinDRUG

Empagliflozin tablets enclosed with red capsules (Capsugel AAEL) by Kragerø Tablettproduksjon AS for blinding purpose

Also known as: Jardiance
Empagliflozin
PlaceboOTHER

Placebo tablets made by Kragerø Tablettproduksjon AS and enclosed with red capsules (Capsugel AAEL) for blinding purpose

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Renal transplant recipient transplanted more than 1 year ago
  • Stable renal function (\<20% deviation in serum creatinine within last 2 months)
  • Diagnosed with PTDM:
  • (fasting plasma glucose ≥7.0 mmol/l and/or 2-hour plasma glucose ≥11.1 mmol/l following an oral glucose tolerance test)
  • Signed informed consent and expected cooperation of the patients

You may not qualify if:

  • Estimated GFR \<30 ml/min/1.73 m2
  • Pregnant or nursing mothers
  • Hypersensitivity to the active substance (IMP) or to any of the excipients
  • Any reason why, in the opinion of the investigator, the patient should not participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital Rikshospitalet

Oslo, 0424, Norway

Location

Related Publications (2)

  • Lo C, Toyama T, Oshima M, Jun M, Chin KL, Hawley CM, Zoungas S. Glucose-lowering agents for treating pre-existing and new-onset diabetes in kidney transplant recipients. Cochrane Database Syst Rev. 2020 Jul 30;8(8):CD009966. doi: 10.1002/14651858.CD009966.pub3.

    PMID: 32803882DERIVED

  • Halden TAS, Kvitne KE, Midtvedt K, Rajakumar L, Robertsen I, Brox J, Bollerslev J, Hartmann A, Asberg A, Jenssen T. Efficacy and Safety of Empagliflozin in Renal Transplant Recipients With Posttransplant Diabetes Mellitus. Diabetes Care. 2019 Jun;42(6):1067-1074. doi: 10.2337/dc19-0093. Epub 2019 Mar 12.

    PMID: 30862658DERIVED

MeSH Terms

Conditions

Diabetes MellitusRenal Insufficiency

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 15, 2017

First Posted

May 17, 2017

Study Start

November 7, 2016

Primary Completion

June 28, 2018

Study Completion

June 28, 2018

Last Updated

March 15, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)