Study to Evaluate Safety and Efficacy of Dutogliptin in Type 2 Diabetes Mellitus Subjects With Moderate and Severe Renal Impairment
NCT ID: NCT00958269
Last Updated: 2010-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
360 participants
INTERVENTIONAL
2009-08-31
2011-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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dutogliptin (double-blind, placebo-controlled period)
weeks 1-26
dutogliptin
100 mg QD
dutogliptin
200 mg QD
dutogliptin (single-blind, active-controlled period)
weeks 27-52
dutogliptin
100 mg QD
dutogliptin
200 mg QD
placebo (double-blind, placebo-controlled period)
weeks 1-26
placebo
placebo (single-blind, active-controlled period)
weeks 27-52
placebo
sitagliptin (single-blind, active-controlled period)
weeks 27-52
sitagliptin
25 mg QD
sitagliptin
50 mg QD
Interventions
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dutogliptin
100 mg QD
dutogliptin
200 mg QD
placebo
sitagliptin
25 mg QD
sitagliptin
50 mg QD
Eligibility Criteria
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Inclusion Criteria
* Renal impairment (moderate and severe)
* Currently on stable doses of background medication of SU, TZD, acarbose, meglitinide, insulin or any combination thereof, or on no antidiabetic drugs at all
* HbA1c 7.0% - 10.5%, inclusive
* Male or female subjects between the ages of 18 and 85 years, inclusive.
Exclusion Criteria
* Kidney transplant
18 Years
85 Years
ALL
No
Sponsors
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Forest Laboratories
INDUSTRY
Phenomix
INDUSTRY
Responsible Party
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Phenomix Corporation
Locations
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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, , Russia
Phenomix Investigational Site 203
Moscow, , Russia
Phenomix Investigational Site 204
Moscow, , Russia
Phenomix Investigational Site 209
Moscow, , Russia
Phenomix Investigational Site 211
Moscow, , Russia
Phenomix Investigational Site 205
Novosibirsk, , Russia
Phenomix Investigational Site 207
Perm, , Russia
Phenomix Investigational Site 206
Petrozavodsk, , Russia
Phenomix Investigational Site 200
Saint Petersburg, , Russia
Phenomix Investigational Site 201
Saint Petersburg, , Russia
Phenomix Investigational Site 210
Saint Petersburg, , Russia
Phenomix Investigational Site 212
Saint Petersburg, , Russia
Phenomix Investigational Site 213
Saint Petersburg, , Russia
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
Countries
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Other Identifiers
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PHX1149-PROT306
Identifier Type: -
Identifier Source: org_study_id
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