Safety and Efficacy of Oral GKT137831 in Patient 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.
Type 2 Diabetes Mellitus With Diabetic Nephropathy
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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|
- 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)
- 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
- 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
|Study Start Date:||October 2013|
|Estimated Study Completion Date:||March 2015|
|Primary Completion Date:||February 2015 (Final data collection date for primary outcome measure)|
GKT137831 100 mg capsules twice a day
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
1 capsule of Placebo, twice a day, oral treatment self-administered by the patient for the 12 weeks of treatment.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02010242
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|Study Director:||Philippe Wiesel, MD||Genkyotex Innovation SAS|