| Outcome Measures: |
Primary: Albuminuria Absolute Value and Ratio to Baseline by Study Visit and Treatment Group, UACR from baseline to Visits 9, 10, and 11 (i.e. weeks 8, 10 and 12 of the treatment period, respectively). Baseline for UACR is defined as the geometric mean of the geometric means of the UACR values measured on Day-14 (visit 4) and Day 1 (visit 5). End of treatment is defined as the geometric mean of the geometric means of the UACR values measured at week 8 (visit 9), week 10 (visit 10) and week 12 (visit 11)., Visit 4 (week -2) to visit 11 (week 12) | Secondary: Glucose Metabolism by Homeostatic Model Assessment (HOMA), Change in homeostasis model assessment-estimated β cell function (HOMA-B) and homeostasis model assessment-estimated insulin resistance (HOMA-IR) from baseline. HOMA-IR = fasting insulin (μIU/mL) x fasting glucose (mM/L)/22.5. A higher HOMA-IR value indicates greater insulin resistance. HOMA-B = 20 x fasting insulin (μIU/mL)/(fasting glucose \[mmol/mL\] - 3.5). Generally, a higher HOMA-B value indicates better beta-cell function, meaning the pancreas is producing insulin effectively., Visits 5 (week 0), 8 (week 6), and 11 (week 12)|Glucose Metabolism HbA1c, Change in HbA1c from Baseline, Visit 5 (week 0), 8 (week 6) and 11 (week 12)|24 Hours Albumin Excretion, Change in 24 hours Albumin excretion from baseline, Visits 5 (week 0) and 11 (week 12)|24 Hours Urine UACR, Change in 24 hours Urine UACR from baseline, Visits 5 (week 0) and 11 (week 12)|eGFR Change by Study Visit, Change in eGFR from baseline by study visit, Visits 5 (week 0), 6 (week 2), 7 (week 4), 8 (week 6), 9 (week 8), 10 (week 10), 11 (week 12), follow up (week 16) | Other: Erectile Dysfunction, Changes at week 12 in IEFF questionnaire assessing erectile dysfunction in patients presenting with these diabetic complications at baseline (Baseline \<=25 in the erectile function domain)- Score from 1 to 30. Score 1 to 10: severe erectile dysfunction, Score 11-16: moderate erectile dysfunction, Score 17-25: light erectile dysfunction, Score 26-30: normal erectile function, Visits 5 (week 0), and 11 (week 12)|Neuropathic Pain, Changes in Visual Analog Scale (VAS) assessing neuropathic leg pain in patients presenting with these diabetic complications at baseline (subjects with a baseline VAS\>=20mm are included). A 100mm VAS scale was used with a range from 0-100mm where a higher score means worse pain. The presence of neuropathic pain is defined a VAS score of at least 20 mm., Visits 5 (week 0), and 11 (week 12)
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| Locations: |
Advanced Arizona Clinical Research, Tucson, Arizona, 85712, United States|The Endocrine Medical Group, Inc, Orange, California, 92868, United States|Clinical Research of South Florida, Coral Gables, Florida, 33134, United States|The Center for Diabetes and Endocrine Care, Hollywood, Florida, 33021, United States|Jacksonville Center for Clinical Research, Jacksonville, Florida, 33216, United States|Genoma Research Group, Inc., Miami, Florida, 33165, United States|Coral Research Clinic, Miami, Florida, 33175, United States|Pines Clinical Research Inc., Pembroke Pines, Florida, 33028, United States|Volunteer Medical Research, Port Charlotte, Florida, 33952, United States|John H. Stroger Jr. Hospital of Cook County, Chicago, Illinois, 60612, United States|Community Medical Research Partners, Indianapolis, Indiana, 46234, United States|Kansas City VA Medical Center, Kansas City, Missouri, 64128, United States|Creighton Diabetes Center, Omaha, Nebraska, 68114, United States|LLC DBA AccessMD Clinical Research, Dayton, Ohio, 45424, United States|Southeast Renal Research Institute, Chattanooga, Tennessee, 37408, United States|The University of Texas Southwestern Medical Center, Dallas, Texas, 75201, United States|17070 Red Oak dr Ste 103, Houston, Texas, 77090, United States|Dialysis West University Health System, San Antonio, Texas, 78229, United States|McGuire VA Medical Center, Richmond, Virginia, 23249, United States|Zablocki VAMC, Milwaukee, Wisconsin, 53095, United States|Royal Prince Alfred Hospital, Camperdown, New South Wales, 2050, Australia|Deakin University school of medicine, Geelong, Victoria, 3220, Australia|Austin Health, Heidelberg, Victoria, 3081, Australia|Baker Institute, Melbourne, Victoria, 3004, Australia|Maroondah ECRU, Ringwood East, Victoria, 3135, Australia|Captain Stirling Medical Centre, Nedlands, Western Australia, 6009, Australia|Endocrine Research Inc., Vancouver, British Columbia, V6E1M7, Canada|LMC Diabetes & Endocrinology, Brampton, Ontario, L6S 0C9, Canada|Clinical Research Solutions, Kitchener, Ontario, N2H 5Z8, Canada|LMC Diabetes and Endocrinology, Thornhill, Ontario, L4J8L7, Canada|Toronto East General Medical Centre, Toronto, Ontario, M4C 5T2, Canada|Medpharmgene, Montreal, Quebec, H1Y 3L1, Canada|Nemocnice Havlickuv Brod, Huzova, 2624, Czechia|Oblastni nemocnice Jicin a.s., Novy Bydzov, Czechia|Faculty Hospital and Palacky University Olomouc, Olomouc, Czechia|Milan Kvapil s.r.o. diabetology ambulance, Prague, 14900, Czechia|IKEM, Praha, 4021, Czechia|Studienzentrum Haematologie/Onkologie/Diabeteologie, Aschaffenburg, 63739, Germany|ZKS Suedbrandenburg GmbH, Elsterwerda, 4906, Germany|IKFE - Institute for Clinical Research and Development, Mainz, 55116, Germany|IDFM, Munchen, 48155, Germany|Centrum Badaa Klinicznych PI-House Sp. z o.o., Gdansk, 80-546, Poland|LANDA Specjalistyczne Gabinety Lekarskie, Krakow, 30-015, Poland|Medicus w Opolu sp z o.o., Opole, 45367, Poland|Praktyka Lekarska Ewa Krzyzagorska, Poznan, 61-655, Poland|KO-MED Centra Kliniczne Sp. z o.o., Staszow, 28200, Poland|Department of Nephrology, Transplantationa and Internal Medicine, Szczecin, 70-711, Poland|Medica Pro Familia Sp. z o.o. S.K.A., Warsaw, 01-868, Poland
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