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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02010242
Recruitment Status : Completed
First Posted : December 12, 2013
Last Update Posted : March 30, 2015
Information provided by (Responsible Party):
Genkyotex Innovation SAS

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus With Diabetic Nephropathy Drug: GKT137831 Drug: Placebo Phase 2

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : October 2013
Actual Primary Completion Date : February 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: GKT137831
GKT137831 100 mg capsules twice a day
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

Placebo Comparator: Placebo
Placebo capsule twice a day
Drug: Placebo
1 capsule of Placebo, twice a day, oral treatment self-administered by the patient for the 12 weeks of treatment.

Primary Outcome Measures :
  1. 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)

Secondary Outcome Measures :
  1. 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

Other Outcome Measures:
  1. Erectile dysfunction [ Time Frame: Visits 5 (week 0), 8 (week 6), and 11 (week 12) ]
    Changes in IEFF questionnaire assessing erectile dysfunction in patients presenting with these diabetic complications at baseline

  2. Neuropathic pain [ Time Frame: Visits 5 (week 0), 8 (week 6), and 11 (week 12) ]
    Changes in Visual Analog Scale (VAS) assessing neuropathic leg pain in patients presenting with these diabetic complications at baseline

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02010242

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Sponsors and Collaborators
Genkyotex Innovation SAS
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Study Director: Philippe Wiesel, MD Genkyotex Innovation SAS
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Responsible Party: Genkyotex Innovation SAS Identifier: NCT02010242    
Other Study ID Numbers: GSN000200
First Posted: December 12, 2013    Key Record Dates
Last Update Posted: March 30, 2015
Last Verified: March 2015
Keywords provided by Genkyotex Innovation SAS:
Type 2 diabetes
Additional relevant MeSH terms:
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Diabetic Nephropathies
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Kidney Diseases
Urologic Diseases
Diabetes Complications
Urination Disorders
Urological Manifestations