Safety and Efficacy of Oral GKT137831 in Patient With Type 2 Diabetes and Albuminuria

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Genkyotex Innovation SAS
Sponsor:
Information provided by (Responsible Party):
Genkyotex Innovation SAS
ClinicalTrials.gov Identifier:
NCT02010242
First received: June 18, 2013
Last updated: July 1, 2014
Last verified: July 2014

June 18, 2013
July 1, 2014
October 2013
December 2014   (final data collection date for primary outcome measure)
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) ] [ Designated as safety issue: No ]
Change in UACR from baseline to Visits 9, 10, and 11 (i.e. weeks 8, 10 and 12 of the treatment period, respectively)
Same as current
Complete list of historical versions of study NCT02010242 on ClinicalTrials.gov Archive Site
Glucose metabolism [ Time Frame: Visits 5 (week 0), 8 (week 6), and 11 (week 12) ] [ Designated as safety issue: No ]
Change in HOMA-B, HOMA-IR and HbA1c from baseline
Same as current
  • Erectile dysfunction [ Time Frame: Visits 5 (week 0), 8 (week 6), and 11 (week 12) ] [ Designated as safety issue: No ]
    Changes in IEFF questionnaire assessing erectile dysfunction in patients presenting with these diabetic complications at baseline
  • Neuropathic pain [ Time Frame: Visits 5 (week 0), 8 (week 6), and 11 (week 12) ] [ Designated as safety issue: No ]
    Changes in Visual Analog Scale (VAS) assessing neuropathic leg pain in patients presenting with these diabetic complications at baseline
Erectile dysfunction and neuropathic pain [ Time Frame: Visits 5 (week 0), 8 (week 6), and 11 (week 12) ] [ Designated as safety issue: No ]
Changes in IEFF questionnaire and Visual Analog Scale (VAS) assessing erectile dysfunction anf neuropathic leg pain, respectively, in patients presenting with these diabetic complications at baseline
 
Safety and Efficacy of Oral GKT137831 in Patient With Type 2 Diabetes and Albuminuria
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

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus With Diabetic Nephropathy
  • Drug: GKT137831
    1 capsule of 100 mg twice a day for the first 6 weeks of treatment, and 2 capsules of 100 mg twice a day for next 6 weeks of treatment
  • Drug: Placebo
    1 capsule of Placebo, twice a day, oral treatment self-administered by the patient for the 12 weeks of treatment.
  • Experimental: GKT137831
    GKT137831 100 mg capsules twice a day
    Intervention: Drug: GKT137831
  • Placebo Comparator: Placebo
    Placebo capsule twice a day
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
January 2015
December 2014   (final data collection date for primary outcome measure)

Key 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 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
Both
18 Years to 80 Years
No
Contact: Philippe Wiesel, MD +33.6.73.63.67.21 philippe.wiesel@genkyotex.com
Contact: Jacques Herve, MSc +33.4.56.44.81.12 jacques.herve@genkyotex.com
United States,   Australia,   Canada,   Czech Republic,   Germany,   Poland
 
NCT02010242
GSN000200
Yes
Genkyotex Innovation SAS
Genkyotex Innovation SAS
Not Provided
Not Provided
Genkyotex Innovation SAS
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP