Safety and Efficacy of Dutogliptin in Patients With Type 2 Diabetes Mellitus Receiving Background Treatment With Glimepiride Alone or in Combination With Metformin or With Pioglitazone Alone
- Registration Number
- NCT01089790
- Lead Sponsor
- Forest Laboratories
- Brief Summary
This study will evaluate the long-term safety and efficacy of dutogliptin in patients with type 2 diabetes mellitus (T2DM).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 141
- Have successfully completed all required visits of a qualifying Phase 3 core protocol
- Be currently receiving treatment for T2DM as set forth in the qualifying Phase 3 core protocol
- Any condition, disease, disorder or clinically relevant laboratory abnormality which, in the opinion of the investigator, would jeopardize the patient's appropriate participation in this study or obscure the effects of treatment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Sitagliptin - 1 Dutogliptin -
- Primary Outcome Measures
Name Time Method To demonstrate safety and tolerability of dutogliptin as assessed by vital signs, adverse event reporting, routine clinical laboratory assessments, and ECG 52 weeks
- Secondary Outcome Measures
Name Time Method To demonstrate maintenance or lowering of HbA1c and fasting plasma glucose. 52 weeks
Trial Locations
- Locations (149)
Forest Investigative Site 061
🇺🇸Anaheim, California, United States
Forest Investigative Site 129
🇺🇸Hollywood, Florida, United States
Forest Investigative Site 156
🇺🇸Boca Raton, Florida, United States
Forest Investigative Site 079
🇺🇸Augusta, Georgia, United States
Forest Investigative Site 077
🇺🇸Decatur, Georgia, United States
Forest Investigative Site 042
🇺🇸Dunwoody, Georgia, United States
Forest Investigative Site 046
🇺🇸Oxon Hill, Maryland, United States
Forest Investigative Site 143
🇺🇸St. Louis, Missouri, United States
Forest Investigative Site 006
🇺🇸Albany, New York, United States
Forest Investigative Site 099
🇺🇸Arlington, Texas, United States
Forest Investigative Site 149
🇺🇸Norman, Oklahoma, United States
Forest Investigative Site 114
🇺🇸Chattanooga, Tennessee, United States
Forest Investigative Site 056
🇺🇸Corpus Christi, Texas, United States
Forest Investigative Site 050
🇺🇸Miami, Florida, United States
Forest Investigative Site 154
🇺🇸Miami, Florida, United States
Forest Investigative Site 072
🇺🇸Las Vegas, Nevada, United States
Forest Investigative Site 023
🇺🇸Cincinnati, Ohio, United States
Forest Investigative Site 135
🇺🇸Durham, North Carolina, United States
Forest Investigative Site 106
🇺🇸Houston, Texas, United States
Forest Investigative Site 146
🇺🇸San Antonio, Texas, United States
Forest Investigative Site 109
🇺🇸San Antonio, Texas, United States
Forest Investigative Site 119
🇺🇸San Antonio, Texas, United States
Forest Investigative Site 115
🇺🇸Colorado Springs, Colorado, United States
Forest Investigative Site 145
🇺🇸San Mateo, California, United States
Forest Investigative Site 111
🇺🇸Northridge, California, United States
Forest Investigative Site 148
🇺🇸Brandenton, Florida, United States
Forest Investigative Site 031
🇺🇸Riverside, California, United States
Forest Investigative Site 073
🇺🇸Clearwater, Florida, United States
Forest Investigative Site 125
🇺🇸Miami Lakes, Florida, United States
Forest Investigative Site 123
🇺🇸Springfield, Illinois, United States
Forest Investigative Site 010
🇺🇸Huntington Park, California, United States
Forest Investigative Site 118
🇺🇸New Bedford, Massachusetts, United States
Forest Investigative Site 025
🇺🇸Muscle Shoals, Alabama, United States
Forest Investigative Site 044
🇺🇸Scottsdale, Arizona, United States
Forest Investigative Site 113
🇺🇸Gilbert, Arizona, United States
Forest Investigative Site 053
🇺🇸Kansas City, Kansas, United States
Forest Investigative Site 034
🇺🇸Covington, Louisiana, United States
Forest Investigative Site 022
🇺🇸Greenbrae, California, United States
Forest Investigative Site 128
🇺🇸Tustin, California, United States
Forest Investigative Site 127
🇺🇸Pembroke Pines, Florida, United States
Forest Investigative Site 062
🇺🇸Jacksonville, Florida, United States
Forest Investigative Site 045
🇺🇸Atlanta, Georgia, United States
Forest Investigative Site 041
🇺🇸Chula Vista, California, United States
Forest Investigative Site 084
🇺🇸Roswell, Georgia, United States
Forest Investigative Site 054
🇺🇸Edina, Minnesota, United States
Forest Investigative Site 152
🇺🇸Anaheim, California, United States
Forest Investigative Site 070
🇺🇸Los Angeles, California, United States
Forest Investigative Site 112
🇺🇸Santa Ana, California, United States
Forest Investigative Site 078
🇺🇸Erlanger, Kentucky, United States
Forest Investigative Site 157
🇺🇸Miami, Florida, United States
Forest Investigative Site 122
🇺🇸Miami, Florida, United States
Forest Investigative Site 030
🇺🇸Peoria, Illinois, United States
Forest Investigative Site 080
🇺🇸Peoria, Arizona, United States
Forest Investigative Site 138
🇺🇸Tamarac, Florida, United States
Forest Investigative Site 096
🇺🇸Goodyear, Arizona, United States
Forest Investigative Site 003
🇺🇸Brockton, Massachusetts, United States
Forest Investigative Site 035
🇺🇸Baltimore, Maryland, United States
Forest Investigative Site 142
🇺🇸St. Louis, Missouri, United States
Forest Investigative Site 008
🇺🇸Wichita, Kansas, United States
Forest Investigative Site 009
🇺🇸Meridian, Idaho, United States
Forest Investigative Site 055
🇺🇸Brockton, Massachusetts, United States
Forest Investigative Site 065
🇺🇸Las Vegas, Nevada, United States
Forest Investigative Site 098
🇺🇸Phoenix, Arizona, United States
Forest Investigative Site 133
🇺🇸Phoenix, Arizona, United States
Forest Investigative Site 076
🇺🇸Salt Lake City, Utah, United States
Forest Investigative Site 064
🇺🇸Birmingham, Alabama, United States
Forest Investigative Site 020
🇺🇸Birmingham, Alabama, United States
Forest Investigative Site 088
🇺🇸Denver, Colorado, United States
Forest Investigative Site 150
🇺🇸Omaha, Nebraska, United States
Forest Investigative Site 027
🇺🇸Milwaukee, Wisconsin, United States
Forest Investigative Site 087
🇺🇸Tucson, Arizona, United States
Forest Investigative Site 161
🇺🇸Miami, Florida, United States
Forest Investigative Site 075
🇺🇸St Petersburg, Florida, United States
Forest Investigative Site 063
🇺🇸West Hills, California, United States
Forest Investigative Site 049
🇺🇸Encinitas, California, United States
Forest Investigative Site 018
🇺🇸Sarasota, Florida, United States
Forest Investigative Site 026
🇺🇸West Palm Beach, Florida, United States
Forest Investigative Site 132
🇺🇸Roswell, Georgia, United States
Forest Investigative Site 100
🇺🇸Evansville, Indiana, United States
Forest Investigative Site 047
🇺🇸Harbor City, California, United States
Forest Investigative Site 091
🇺🇸Roseville, California, United States
Forest Investigative Site 144
🇺🇸Hialeah, Florida, United States
Forest Investigative Site 052
🇺🇸DeLand, Florida, United States
Forest Investigative Site 012
🇺🇸Ocala, Florida, United States
Forest Investigative Site 131
🇺🇸Ormond Beach, Florida, United States
Forest Investigative Site 097
🇺🇸Evansville, Indiana, United States
Forest Investigative Site 024
🇺🇸Madisonville, Kentucky, United States
Forest Investigative Site 165
🇺🇸Rockville, Maryland, United States
Forest Investigative Site 163
🇺🇸Cadillac, Michigan, United States
Forest Investigative Site 029
🇺🇸St. Clair Shores, Michigan, United States
Forest Investigative Site 007
🇺🇸Waltham, Massachusetts, United States
Forest Investigative Site 013
🇺🇸Grand Island, Nebraska, United States
Forest Investigative Site 002
🇺🇸Dearborn, Michigan, United States
Forest Investigative Site 147
🇺🇸Berkeley Heights, New Jersey, United States
Forest Investigative Site 081
🇺🇸New Hyde Park, New York, United States
Forest Investigative Site 016
🇺🇸New York, New York, United States
Forest Investigative Site 151
🇺🇸New York, New York, United States
Forest Investigative Site 155
🇺🇸Asheboro, North Carolina, United States
Forest Investigative Site 051
🇺🇸Charlotte, North Carolina, United States
Forest Investigative Site 058
🇺🇸Lenoir, North Carolina, United States
Forest Investigative Site 094
🇺🇸Charlotte, North Carolina, United States
Forest Investigative Site 039
🇺🇸Akron, Ohio, United States
Forest Investigative Site 117
🇺🇸Charlotte, North Carolina, United States
Forest Investigative Site 038
🇺🇸Morehead City, North Carolina, United States
Forest Investigative Site 040
🇺🇸Salisbury, North Carolina, United States
Forest Investigative Site 043
🇺🇸Columbus, Ohio, United States
Forest Investigative Site 032
🇺🇸Kettering, Ohio, United States
Forest Investigative Site 057
🇺🇸Dayton, Ohio, United States
Forest Investigative Site 141
🇺🇸Marion, Ohio, United States
Forest Investigative Site 159
🇺🇸Marion, Ohio, United States
Forest Investigative Site 083
🇺🇸Bethany, Oklahoma, United States
Forest Investigative Site 153
🇺🇸Zanesville, Ohio, United States
Forest Investigative Site 102
🇺🇸Ashland, Oregon, United States
Forest Investigative Site 005
🇺🇸Eugene, Oregon, United States
Forest Investigative Site 001
🇺🇸Medford, Oregon, United States
Forest Investigative Site 126
🇺🇸Jenkintown, Pennsylvania, United States
Forest Investigative Site 037
🇺🇸Harleysville, Pennsylvania, United States
Forest Investigative Site 158
🇺🇸Morrisville, Pennsylvania, United States
Forest Investigative Site 066
🇺🇸Philadelphia, Pennsylvania, United States
Forest Investigative Site 130
🇺🇸Bensalem, Pennsylvania, United States
Forest Investigative Site 090
🇺🇸Manning, South Carolina, United States
Forest Investigative Site 103
🇺🇸Greer, South Carolina, United States
Forest Investigative Site 048
🇺🇸Bristol, Tennessee, United States
Forest Investigative Site 036
🇺🇸Tipton, Pennsylvania, United States
Forest Investigative Site 033
🇺🇸Pelzer, South Carolina, United States
Forest Investigative Site 104
🇺🇸Chattanooga, Tennessee, United States
Forest Investigative Site 071
🇺🇸Dallas, Texas, United States
Forest Investigative Site 124
🇺🇸Dallas, Texas, United States
Forest Investigative Site 162
🇺🇸Desoto, Texas, United States
Forest Investigative Site 017
🇺🇸Dallas, Texas, United States
Forest Investigative Site 014
🇺🇸Irving, Texas, United States
Forest Investigative Site 136
🇺🇸Houston, Texas, United States
Forest Investigative Site 139
🇺🇸Irving, Texas, United States
Forest Investigative Site 160
🇺🇸New Braunfels, Texas, United States
Forest Investigative Site 028
🇺🇸Virginia Beach, Virginia, United States
Forest Investigative Site 121
🇺🇸Arlington, Virginia, United States
Forest Investigative Site 068
🇺🇸Renton, Washington, United States
Forest Investigative Site 092
🇺🇸Spokane, Washington, United States
Forest Investigative Site 140
🇺🇸Sacramento, California, United States
Forest Investigative Site 082
🇺🇸Winston-Salem, North Carolina, United States
Forest Investigative Site 067
🇺🇸Sacramento, California, United States
Forest Investigative Site 015
🇺🇸Orlando, Florida, United States
Forest Investigative Site 107
🇺🇸Lexington, Kentucky, United States
Forest Investigative Site 137
🇺🇸Albuquerque, New Mexico, United States
Forest Investigative Site 101
🇺🇸Albuquerque, New Mexico, United States
Forest Investigative Site 011
🇺🇸Walnut Creek, California, United States
Forest Investigative Site 059
🇺🇸Chandler, Arizona, United States
Forest Investigative Site 004
🇺🇸Daytona Beach, Florida, United States
Forest Investigative Site 069
🇺🇸New Port Richey, Florida, United States