Clinical trial NCT01089790: 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
Official title: A Phase III, Multicenter, Double-blind, Active-Controlled, 52 Week Extension Study to Evaluate the 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
Collaborators: name: Phenomix
First posted: 2010-03-19
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Maximum age (years): 86
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the long-term safety and efficacy of dutogliptin in patients with type 2 diabetes mellitus (T2DM).


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: To demonstrate safety and tolerability of dutogliptin as assessed by vital signs, adverse event reporting, routine clinical laboratory assessments, and ECG
timeFrame: 52 weeks
Secondary outcomes:
measure: To demonstrate maintenance or lowering of HbA1c and fasting plasma glucose.
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Forest Investigative Site 064
state: Alabama
city: Birmingham
country: United States
facility: Forest Investigative Site 020
state: Alabama
city: Muscle Shoals
country: United States
facility: Forest Investigative Site 025
state: Alabama
city: Chandler
country: United States
facility: Forest Investigative Site 059
state: Arizona
city: Gilbert
country: United States
facility: Forest Investigative Site 113
state: Arizona
city: Goodyear
country: United States
facility: Forest Investigative Site 096
state: Arizona
city: Peoria
country: United States
facility: Forest Investigative Site 080
state: Arizona
city: Phoenix
country: United States
facility: Forest Investigative Site 098
state: Arizona
city: Phoenix
country: United States
facility: Forest Investigative Site 133
state: Arizona
city: Scottsdale
country: United States
facility: Forest Investigative Site 044
state: Arizona
city: Tucson
country: United States
facility: Forest Investigative Site 087
state: Arizona
city: Anaheim
country: United States
facility: Forest Investigative Site 061
state: California
city: Anaheim
country: United States
facility: Forest Investigative Site 152
state: California
city: Chula Vista
country: United States
facility: Forest Investigative Site 041
state: California
city: Encinitas
country: United States
facility: Forest Investigative Site 049
state: California
city: Greenbrae
country: United States
facility: Forest Investigative Site 022
state: California
city: Harbor City
country: United States
facility: Forest Investigative Site 047
state: California
city: Huntington Park
country: United States
facility: Forest Investigative Site 010
state: California
city: Los Angeles
country: United States
facility: Forest Investigative Site 070
state: California
city: Northridge
country: United States
facility: Forest Investigative Site 111
state: California
city: Riverside
country: United States
facility: Forest Investigative Site 031
state: California
city: Roseville
country: United States
facility: Forest Investigative Site 091
state: California
city: Sacramento
country: United States
facility: Forest Investigative Site 140
state: California
city: Sacramento
country: United States
facility: Forest Investigative Site 067
state: California
city: San Mateo
country: United States
facility: Forest Investigative Site 145
state: California
city: Santa Ana
country: United States
facility: Forest Investigative Site 112
state: California
city: Tustin
country: United States
facility: Forest Investigative Site 128
state: California
city: Walnut Creek
country: United States
facility: Forest Investigative Site 011
state: California
city: West Hills
country: United States
facility: Forest Investigative Site 063
state: California
city: Colorado Springs
country: United States
facility: Forest Investigative Site 115
state: Colorado
city: Denver
country: United States
facility: Forest Investigative Site 088
state: Colorado
city: Boca Raton
country: United States
facility: Forest Investigative Site 156
state: Florida
city: Brandenton
country: United States
facility: Forest Investigative Site 148
state: Florida
city: Clearwater
country: United States
facility: Forest Investigative Site 073
state: Florida
city: Daytona Beach
country: United States
facility: Forest Investigative Site 004
state: Florida
city: DeLand
country: United States
facility: Forest Investigative Site 052
state: Florida
city: Hialeah
country: United States
facility: Forest Investigative Site 144
state: Florida
city: Hollywood
country: United States
facility: Forest Investigative Site 129
state: Florida
city: Jacksonville
country: United States
facility: Forest Investigative Site 062
state: Florida
city: Miami Lakes
country: United States
facility: Forest Investigative Site 125
state: Florida
city: Miami
country: United States
facility: Forest Investigative Site 161
state: Florida
city: Miami
country: United States
facility: Forest Investigative Site 157
state: Florida
city: Miami
country: United States
facility: Forest Investigative Site 154
state: Florida
city: Miami
country: United States
facility: Forest Investigative Site 050
state: Florida
city: Miami
country: United States
facility: Forest Investigative Site 122
state: Florida
city: New Port Richey
country: United States
facility: Forest Investigative Site 069
state: Florida
city: Ocala
country: United States
facility: Forest Investigative Site 012
state: Florida
city: Orlando
country: United States
facility: Forest Investigative Site 015
state: Florida
city: Ormond Beach
country: United States
facility: Forest Investigative Site 131
state: Florida
city: Pembroke Pines
country: United States
facility: Forest Investigative Site 127
state: Florida
city: Sarasota
country: United States
facility: Forest Investigative Site 018
state: Florida
city: St Petersburg
country: United States
facility: Forest Investigative Site 075
state: Florida
city: Tamarac
country: United States
facility: Forest Investigative Site 138
state: Florida
city: West Palm Beach
country: United States
facility: Forest Investigative Site 026
state: Florida
city: Atlanta
country: United States
facility: Forest Investigative Site 045
state: Georgia
city: Augusta
country: United States
facility: Forest Investigative Site 079
state: Georgia
city: Decatur
country: United States
facility: Forest Investigative Site 077
state: Georgia
city: Dunwoody
country: United States
facility: Forest Investigative Site 042
state: Georgia
city: Roswell
country: United States
facility: Forest Investigative Site 084
state: Georgia
city: Roswell
country: United States
facility: Forest Investigative Site 132
state: Georgia
city: Meridian
country: United States
facility: Forest Investigative Site 009
state: Idaho
city: Peoria
country: United States
facility: Forest Investigative Site 030
state: Illinois
city: Springfield
country: United States
facility: Forest Investigative Site 123
state: Illinois
city: Evansville
country: United States
facility: Forest Investigative Site 100
state: Indiana
city: Evansville
country: United States
facility: Forest Investigative Site 097
state: Indiana
city: Kansas City
country: United States
facility: Forest Investigative Site 053
state: Kansas
city: Wichita
country: United States
facility: Forest Investigative Site 008
state: Kansas
city: Erlanger
country: United States
facility: Forest Investigative Site 078
state: Kentucky
city: Lexington
country: United States
facility: Forest Investigative Site 107
state: Kentucky
city: Madisonville
country: United States
facility: Forest Investigative Site 024
state: Kentucky
city: Covington
country: United States
facility: Forest Investigative Site 034
state: Louisiana
city: Baltimore
country: United States
facility: Forest Investigative Site 035
state: Maryland
city: Oxon Hill
country: United States
facility: Forest Investigative Site 046
state: Maryland
city: Rockville
country: United States
facility: Forest Investigative Site 165
state: Maryland
city: Brockton
country: United States
facility: Forest Investigative Site 003
state: Massachusetts
city: Brockton
country: United States
facility: Forest Investigative Site 055
state: Massachusetts
city: New Bedford
country: United States
facility: Forest Investigative Site 118
state: Massachusetts
city: Waltham
country: United States
facility: Forest Investigative Site 007
state: Massachusetts
city: Cadillac
country: United States
facility: Forest Investigative Site 163
state: Michigan
city: Dearborn
country: United States
facility: Forest Investigative Site 002
state: Michigan
city: St. Clair Shores
country: United States
facility: Forest Investigative Site 029
state: Michigan
city: Edina
country: United States
facility: Forest Investigative Site 054
state: Minnesota
city: St. Louis
country: United States
facility: Forest Investigative Site 142
state: Missouri
city: St. Louis
country: United States
facility: Forest Investigative Site 143
state: Missouri
city: Grand Island
country: United States
facility: Forest Investigative Site 013
state: Nebraska
city: Omaha
country: United States
facility: Forest Investigative Site 150
state: Nebraska
city: Las Vegas
country: United States
facility: Forest Investigative Site 072
state: Nevada
city: Las Vegas
country: United States
facility: Forest Investigative Site 065
state: Nevada
city: Berkeley Heights
country: United States
facility: Forest Investigative Site 147
state: New Jersey
city: Albuquerque
country: United States
facility: Forest Investigative Site 137
state: New Mexico
city: Albuquerque
country: United States
facility: Forest Investigative Site 101
state: New Mexico
city: Albany
country: United States
facility: Forest Investigative Site 006
state: New York
city: New Hyde Park
country: United States
facility: Forest Investigative Site 081
state: New York
city: New York
country: United States
facility: Forest Investigative Site 016
state: New York
city: New York
country: United States
facility: Forest Investigative Site 151
state: New York
city: Asheboro
country: United States
facility: Forest Investigative Site 155
state: North Carolina
city: Charlotte
country: United States
facility: Forest Investigative Site 094
state: North Carolina
city: Charlotte
country: United States
facility: Forest Investigative Site 051
state: North Carolina
city: Charlotte
country: United States
facility: Forest Investigative Site 117
state: North Carolina
city: Durham
country: United States
facility: Forest Investigative Site 135
state: North Carolina
city: Lenoir
country: United States
facility: Forest Investigative Site 058
state: North Carolina
city: Morehead City
country: United States
facility: Forest Investigative Site 038
state: North Carolina
city: Salisbury
country: United States
facility: Forest Investigative Site 040
state: North Carolina
city: Winston-Salem
country: United States
facility: Forest Investigative Site 082
state: North Carolina
city: Akron
country: United States
facility: Forest Investigative Site 039
state: Ohio
city: Cincinnati
country: United States
facility: Forest Investigative Site 023
state: Ohio
city: Columbus
country: United States
facility: Forest Investigative Site 043
state: Ohio
city: Dayton
country: United States
facility: Forest Investigative Site 057
state: Ohio
city: Kettering
country: United States
facility: Forest Investigative Site 032
state: Ohio
city: Marion
country: United States
facility: Forest Investigative Site 141
state: Ohio
city: Marion
country: United States
facility: Forest Investigative Site 159
state: Ohio
city: Zanesville
country: United States
facility: Forest Investigative Site 153
state: Ohio
city: Bethany
country: United States
facility: Forest Investigative Site 083
state: Oklahoma
city: Norman
country: United States
facility: Forest Investigative Site 149
state: Oklahoma
city: Ashland
country: United States
facility: Forest Investigative Site 102
state: Oregon
city: Eugene
country: United States
facility: Forest Investigative Site 005
state: Oregon
city: Medford
country: United States
facility: Forest Investigative Site 001
state: Oregon
city: Bensalem
country: United States
facility: Forest Investigative Site 130
state: Pennsylvania
city: Harleysville
country: United States
facility: Forest Investigative Site 037
state: Pennsylvania
city: Jenkintown
country: United States
facility: Forest Investigative Site 126
state: Pennsylvania
city: Morrisville
country: United States
facility: Forest Investigative Site 158
state: Pennsylvania
city: Philadelphia
country: United States
facility: Forest Investigative Site 066
state: Pennsylvania
city: Tipton
country: United States
facility: Forest Investigative Site 036
state: Pennsylvania
city: Greer
country: United States
facility: Forest Investigative Site 103
state: South Carolina
city: Manning
country: United States
facility: Forest Investigative Site 090
state: South Carolina
city: Pelzer
country: United States
facility: Forest Investigative Site 033
state: South Carolina
city: Bristol
country: United States
facility: Forest Investigative Site 048
state: Tennessee
city: Chattanooga
country: United States
facility: Forest Investigative Site 114
state: Tennessee
city: Chattanooga
country: United States
facility: Forest Investigative Site 104
state: Tennessee
city: Arlington
country: United States
facility: Forest Investigative Site 099
state: Texas
city: Corpus Christi
country: United States
facility: Forest Investigative Site 056
state: Texas
city: Dallas
country: United States
facility: Forest Investigative Site 071
state: Texas
city: Dallas
country: United States
facility: Forest Investigative Site 017
state: Texas
city: Dallas
country: United States
facility: Forest Investigative Site 124
state: Texas
city: Desoto
country: United States
facility: Forest Investigative Site 162
state: Texas
city: Houston
country: United States
facility: Forest Investigative Site 136
state: Texas
city: Houston
country: United States
facility: Forest Investigative Site 106
state: Texas
city: Irving
country: United States
facility: Forest Investigative Site 014
state: Texas
city: Irving
country: United States
facility: Forest Investigative Site 139
state: Texas
city: New Braunfels
country: United States
facility: Forest Investigative Site 160
state: Texas
city: San Antonio
country: United States
facility: Forest Investigative Site 146
state: Texas
city: San Antonio
country: United States
facility: Forest Investigative Site 109
state: Texas
city: San Antonio
country: United States
facility: Forest Investigative Site 119
state: Texas
city: Salt Lake City
country: United States
facility: Forest Investigative Site 076
state: Utah
city: Arlington
country: United States
facility: Forest Investigative Site 121
state: Virginia
city: Virginia Beach
country: United States
facility: Forest Investigative Site 028
state: Virginia
city: Renton
country: United States
facility: Forest Investigative Site 068
state: Washington
city: Spokane
country: United States
facility: Forest Investigative Site 092
state: Washington
city: Milwaukee
country: United States
facility: Forest Investigative Site 027
state: Wisconsin
Study officials:
affiliation: Forest Research Institute, a subsidiary of Forest Laboratories Inc.
name: Kaity Posada, PharmD
role: STUDY_DIRECTOR
References: