Clinical trial NCT00958269: Study to Evaluate Safety and Efficacy of Dutogliptin in Type 2 Diabetes Mellitus Subjects With Moderate and Severe Renal Impairment
Official title: A Randomized, Double-Blind, Placebo- and Sitagliptin-Controlled, Multi-Center Study to Evaluate Safety and Efficacy of Dutogliptin in Type 2 Diabetes Mellitus Subjects With Moderate and Severe Renal Impairment Including Subjects on Hemodialysis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Renal Impairment
Keywords: diabetes
DPP4 inhibitor
dutogliptin
PHX1149
Lead sponsor: Phenomix
Sponsor class: INDUSTRY
Collaborators: name: Forest Laboratories
First posted: 2009-08-13
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and tolerability of dutogliptin in Type 2 diabetic subjects with moderate or severe renal impairment.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes mellitus
* 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:

* Type 1 diabetes mellitus or history of diabetic ketoacidosis, mature onset diabetes of the young (MODY)
* Kidney transplant

Primary outcomes:
measure: Safety and tolerability of dutogliptin as assessed by analysis of AEs/SAEs, laboratory data, vital signs, and ECGs
timeFrame: 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 outcomes:
measure: Change of HbA1c
timeFrame: Day 1 to Day 182
measure: Change of fasting plasma glucose
timeFrame: Day 1 to Day 182
measure: Plasma dutogliptin levels
timeFrame: Days 1, 198 and 182
measure: Per cent ex vivo DPP4 inhibition after drug dosing
timeFrame: Days 1, 98, and 182
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Phenomix Investigational Site 115
state: Arizona
city: Long Beach
country: United States
facility: Phenomix Investigational Site 121
state: California
city: Lynwood
country: United States
facility: Phenomix Investigational Site 110
state: California
city: Lynwood
country: United States
facility: Phenomix Investigational Site 118
state: California
city: Orange
country: United States
facility: Phenomix Investigational Site 119
state: California
city: Palm Springs
country: United States
facility: Phenomix Investigational Site 109
state: California
city: Whittier
country: United States
facility: Phenomix Investigational Site 122
state: California
city: Lauderdale Lakes
country: United States
facility: Phenomix Investigational Site 112
state: Florida
city: Ocala
country: United States
facility: Phenomix Investigational Site 104
state: Florida
city: Pembroke Pines
country: United States
facility: Phenomix Investigational Site 116
state: Florida
city: Augusta
country: United States
facility: Phenomix Investigational Site 101
state: Georgia
city: Honolulu
country: United States
facility: Phenomix Investigational Site 117
state: Hawaii
city: Baton Rouge
country: United States
facility: Phenomix Investigational Site 102
state: Louisiana
city: Rockville
country: United States
facility: Phenomix Investigational Site 100
state: Maryland
city: Rockville
country: United States
facility: Phenomix Investigational Site 125
state: Maryland
city: Springfield Gardens
country: United States
facility: Phenomix Investigational Site 114
state: New York
city: Winston-Salem
country: United States
facility: Phenomix Investigational Site 120
state: North Carolina
city: Columbia
country: United States
facility: Phenomix Investigational Site 107
state: South Carolina
city: Nashville
country: United States
facility: Phenomix Investigational Site 111
state: Tennessee
city: Fort Worth
country: United States
facility: Phenomix Investigational Site 103
state: Texas
city: Houston
country: United States
facility: Phenomix Investigational Site 106
state: Texas
city: San Antonio
country: United States
facility: Phenomix Investigational Site 108
state: Texas
city: Alexandria
country: United States
facility: Phenomix Investigational Site 113
state: Virginia
city: Kemerovo
country: Russian Federation
facility: Phenomix Investigational Site 208
city: Moscow
country: Russian Federation
facility: Phenomix Investigational Site 203
city: Moscow
country: Russian Federation
facility: Phenomix Investigational Site 204
city: Moscow
country: Russian Federation
facility: Phenomix Investigational Site 209
city: Moscow
country: Russian Federation
facility: Phenomix Investigational Site 211
city: Novosibirsk
country: Russian Federation
facility: Phenomix Investigational Site 205
city: Perm.
country: Russian Federation
facility: Phenomix Investigational Site 207
city: Petrozavodsk
country: Russian Federation
facility: Phenomix Investigational Site 206
city: St. Petersburg
country: Russian Federation
facility: Phenomix Investigational Site 200
city: St. Petersburg
country: Russian Federation
facility: Phenomix Investigational Site 201
city: St. Petersburg
country: Russian Federation
facility: Phenomix Investigational Site 210
city: St. Petersburg
country: Russian Federation
facility: Phenomix Investigational Site 212
city: St. Petersburg
country: Russian Federation
facility: Phenomix Investigational Site 213
city: Chernivtsi
country: Ukraine
facility: Phenomix Investigational Site 304
city: Kyiv
country: Ukraine
facility: Phenomix Investigational Site 300
city: Kyiv
country: Ukraine
facility: Phenomix Investigational Site 301
city: Kyiv
country: Ukraine
facility: Phenomix Investigational Site 306
city: Odesa
country: Ukraine
facility: Phenomix Investigational Site 302
city: Vinnytsa
country: Ukraine
facility: Phenomix Investigational Site 303
city: Zaporizhzhya
country: Ukraine
facility: Phenomix Investigational Site 307
Study officials:
References: