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Clinical Trial Details

Trial ID: L3765
Source ID: NCT00958269
Associated Drug: Dutogliptin
Title: Study to Evaluate Safety and Efficacy of Dutogliptin in Type 2 Diabetes Mellitus Subjects With Moderate and Severe Renal Impairment
Acronym:
Status: TERMINATED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus|Renal Impairment
Interventions: DRUG: dutogliptin|DRUG: dutogliptin|DRUG: placebo|DRUG: sitagliptin|DRUG: sitagliptin
Outcome Measures: Primary: Safety and tolerability of dutogliptin as assessed by analysis of AEs/SAEs, laboratory data, vital signs, and ECGs, Day 1 through day 182 (end of the 26-week, double-blind, placebo-controlled period) and through Day 364 (end of the 26-week, sitagliptin-controlled period of the study) | Secondary: Change of HbA1c, Day 1 to Day 182|Change of fasting plasma glucose, Day 1 to Day 182|Plasma dutogliptin levels, Days 1, 198 and 182|Per cent ex vivo DPP4 inhibition after drug dosing, Days 1, 98, and 182
Sponsor/Collaborators: Sponsor: Phenomix | Collaborators: Forest Laboratories
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 360
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2009-08
Completion Date: 2011-11
Results First Posted:
Last Update Posted: 2010-02-03
Locations: Phenomix Investigational Site 115, Tempe, Arizona, United States|Phenomix Investigational Site 121, Long Beach, California, United States|Phenomix Investigational Site 110, Lynwood, California, United States|Phenomix Investigational Site 118, Lynwood, California, United States|Phenomix Investigational Site 119, Orange, California, United States|Phenomix Investigational Site 109, Palm Springs, California, United States|Phenomix Investigational Site 122, Whittier, California, United States|Phenomix Investigational Site 112, Lauderdale Lakes, Florida, United States|Phenomix Investigational Site 104, Ocala, Florida, United States|Phenomix Investigational Site 116, Pembroke Pines, Florida, United States|Phenomix Investigational Site 101, Augusta, Georgia, United States|Phenomix Investigational Site 117, Honolulu, Hawaii, United States|Phenomix Investigational Site 102, Baton Rouge, Louisiana, United States|Phenomix Investigational Site 100, Rockville, Maryland, United States|Phenomix Investigational Site 125, Rockville, Maryland, United States|Phenomix Investigational Site 114, Springfield Gardens, New York, United States|Phenomix Investigational Site 120, Winston-Salem, North Carolina, United States|Phenomix Investigational Site 107, Columbia, South Carolina, United States|Phenomix Investigational Site 111, Nashville, Tennessee, United States|Phenomix Investigational Site 103, Fort Worth, Texas, United States|Phenomix Investigational Site 106, Houston, Texas, United States|Phenomix Investigational Site 108, San Antonio, Texas, United States|Phenomix Investigational Site 113, Alexandria, Virginia, United States|Phenomix Investigational Site 208, Kemerovo, Russian Federation|Phenomix Investigational Site 203, Moscow, Russian Federation|Phenomix Investigational Site 204, Moscow, Russian Federation|Phenomix Investigational Site 209, Moscow, Russian Federation|Phenomix Investigational Site 211, Moscow, Russian Federation|Phenomix Investigational Site 205, Novosibirsk, Russian Federation|Phenomix Investigational Site 207, Perm., Russian Federation|Phenomix Investigational Site 206, Petrozavodsk, Russian Federation|Phenomix Investigational Site 200, St. Petersburg, Russian Federation|Phenomix Investigational Site 201, St. Petersburg, Russian Federation|Phenomix Investigational Site 210, St. Petersburg, Russian Federation|Phenomix Investigational Site 212, St. Petersburg, Russian Federation|Phenomix Investigational Site 213, St. Petersburg, Russian Federation|Phenomix Investigational Site 304, Chernivtsi, Ukraine|Phenomix Investigational Site 300, Kyiv, Ukraine|Phenomix Investigational Site 301, Kyiv, Ukraine|Phenomix Investigational Site 306, Kyiv, Ukraine|Phenomix Investigational Site 302, Odesa, Ukraine|Phenomix Investigational Site 303, Vinnytsa, Ukraine|Phenomix Investigational Site 307, Zaporizhzhya, Ukraine
URL: https://clinicaltrials.gov/show/NCT00958269

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress