Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
drksid header

  DRKS00006384

Trial Description

start of 1:1-Block title

Title

A Double-Blind, Randomized, Placebo-Controlled, Phase 2 Study Evaluating the Safety and Efficacy of Oral GKT137831 in Patients With Type 2 Diabetes and Albuminuria

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

NADPH oxidase enzymes (NOX) have been implicated in the development of several diabetic
complications including diabetic nephropathy. GKT137831 is the first in class NOX1/4
inhibitor.

The primary objective of this study is to evaluate the efficacy of oral GKT137831 in
patients with residual albuminuria despite maximal inhibition of the renin angiotensin
aldosterone system.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

A double-blind, placebo-controlled, randomized, multicenter, parallel group Phase 2 study
assessing a 12-week period of treatment with oral GKT137831 administered in addition to
standard of care for patients with type 2 diabetes.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00006384
  •   2014/11/17
  •   2013/06/18
  •   no
  •   [---]*
  •   [---]*
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   NCT02010242  (ClinicalTrials.gov)
  •   GSN000200  (Genkyotex Innovation SAS)
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Type 2 Diabetes Mellitus With Diabetic Nephropathy
  •   E11.2 -  Non-insulin-dependent diabetes mellitus; With renal complications
  •   N08.3 -  Glomerular disorders in diabetes mellitus
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Drug: GKT137831
  •   Drug: Placebo
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, caregiver, investigator/therapist, assessor
  •   Placebo
  •   Treatment
  •   Parallel
  •   II
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

- Albuminuria; time frame: Visits 4 (week -2), 5 (week 0), 6 (week 2), 7 (week 4), 8 (week 6), 9 (week 8), 10 (week 10), 11 (week 12), and 12 (week 16); Change in UACR from baseline to Visits 9, 10, and 11 (i.e. weeks 8, 10 and 12 of the treatment period, respectively)

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

- Glucose metabolism; time frame: Visits 5 (week 0), 8 (week 6), and 11 (week 12); Change in HOMA-B, HOMA-IR and HbA1c from baseline

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   United States
  •   Australia
  •   Canada
  •   Czech Republic
  •   Germany
  •   Poland
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   [---]*
  •   2013/10/31
  •   200
  •   Multicenter trial
  •   International
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   80   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

- Male or female aged 18 to 80 years

- History of type 2 diabetes, defined as fasting plasma glucose ≥7.0 mmol/L (126 mg/dL)
or a glycated hemoglobin (HbA1c) >6.5% (48 mmol/mol) on at least 2 occasions prior to
screening.

- Albuminuria defined as a UACR of 300 to 3500 mg/g.

- An eGFR ≥30 mL/min/1.73 m2, as calculated by the CKD-EPI formula.

- Must be taking an ACEI or an ARB for at least 6 weeks prior to the first screening
visit (Visit 1) and during the screening period. The dose must have been stable for
at least 4 weeks prior to the first screening visit (Visit 1). Combination therapy
associating an ACEI and an ARB is not permitted.

Key

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

- History of type 1 diabetes

- Any other non-diabetic kidney disease(s) except for hypertensive nephropathy which is
acceptable.

- Diagnostic or interventional procedure requiring a contrast agent within 4 weeks of
the first screening visit (Visit 1) or planned during the study.

- History of renal transplant or planned renal transplant during the study.

- A history of acute renal dialysis or acute kidney injury (defined according to the
Kidney Disease: Improving Global Outcomes [KDIGO] definition) within 12 weeks of the
first screening visit (Visit 1)

- HbA1c level >11% (97 mmol/mol).

- History of hypothyroidism requiring hormone replacement therapy.

- History of active cardiovascular disease

- A personal or family history of long QT syndrome.

- Administration of any investigational product within 30 days or within 5 half-lives
of the investigational agent

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Genkyotex Innovation SAS
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Genkyotex Innovation SAS
    • Philippe Wiesel, MD 
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Genkyotex Innovation SAS
    • Philippe Wiesel, MD 
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up continuing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   2
  •   2014/11/27
* This entry means the parameter is not applicable or has not been set.