Clinical trial NCT00947557: Safety and Efficacy of Dutogliptin in Patients With Type 2 Diabetes Mellitus (T2DM) on Background Therapy With Glimepiride With or Without Metformin
Official title: A Phase III, Randomized, Double-Blind, Placebo-controlled, Multicenter Study To Evaluate The Safety and Efficacy of Dutogliptin in Patients With Type 2 Diabetes Mellitus on Background Treatment With Glimepiride With or Without Metformin
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type II
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
Collaborators: name: Phenomix
First posted: 2009-07-28
Enrollment: 677
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: This study will evaluate the safety and efficacy of dutogliptin in patients with type 2 diabetes mellitus (T2DM) who are receiving background therapy of glimepiride with or without metformin.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes mellitus, diagnosed at least 3 months prior to Screening (Visit 1)
* BMI 20 to 48 kg/m2, inclusive
* HbA1c 7.0% - 10.0%, inclusive
* Age 18 to 85 years, inclusive

Exclusion Criteria:

* Currently on 3 or more oral antidiabetic drugs or insulin.
* Type 1 diabetes mellitus

Primary outcomes:
measure: Hemoglobin A1c (HbA1c)
timeFrame: HbA1c is drawn at Visit 1 (Week -16 to -4), Visit 3 (Week -2), Visit 4 (Week 0), Visit 5 (Week 4), Visit 6 (Week 10), Visit 7 (Week 18), Visit 8 (Week 26).
Secondary outcomes:
measure: Fasting Plasma Glucose (FPG)
timeFrame: FPG is drawn at Visit 1 (Week -16 to -4), Visit 2 (Week -4), Visit 3 (Week -2), Visit 4 (Week 0), Visit 5 (Week 4), Visit 6 (Week 10), Visit 7 (Week 18), Visit 8 (Week 26).
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: Litchfield
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: Scottsdale
country: United States
facility: Forest Investigative Site 044
state: Arizona
city: Anaheim
country: United States
facility: Forest Investigative Site 061
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 067
state: California
city: Santa Ana
country: United States
facility: Forest Investigative Site 112
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: 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: 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: 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 050
state: Florida
city: Miami
country: United States
facility: Forest Investigative Site 021
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: 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: 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: 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: Lexington
country: United States
facility: Forest Investigative Site 107
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: 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: 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: 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: Albuquerque
country: United States
facility: Forest Investigative Site 101
state: New Mexico
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: 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: 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: Bethany
country: United States
facility: Forest Investigative Site 083
state: Oklahoma
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: Jenkintown
country: United States
facility: Forest Investigative Site 126
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: Pelzer
country: United States
facility: Forest Investigative Site 033
state: South Carolina
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: Irving
country: United States
facility: Forest Investigative Site 014
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: 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: Gomel
country: Belarus
facility: Forest Investigative Site 202
city: Grodno
country: Belarus
facility: Forest Investigative Site 208
city: Minsk
country: Belarus
facility: Forest Investigative Site 207
city: Mogilev
country: Belarus
facility: Forest Investigative Site 209
city: Vitebsk
country: Belarus
facility: Forest Investigative Site 206
city: Medellin
country: Colombia
facility: Forest Investigative Site 302
state: Antioquia
city: Budapest
country: Hungary
facility: Forest Investigative Site 506
city: Szentes
country: Hungary
facility: Forest Investigative Site 504
city: Hyderabad
country: India
facility: Forest Investigative Site 621
state: Andhra Pradesh
city: Vijayawada
country: India
facility: Forest Investigative Site 614
state: Andhra Pradesh
city: Visakhapatanam
country: India
facility: Forest Investigative Site 610
state: Andhra Pradesh
city: Mapusa
country: India
facility: Forest Investigative Site 609
state: Goa
city: Ahmedabad
country: India
facility: Forest Investigative Site 618
state: Gujarat
city: Haryana
country: India
facility: Forest Investigative Site 620
state: Karnal
city: Bangalore
country: India
facility: Forest Investigative Site 607
state: Karnataka
city: Bangalore
country: India
facility: Forest Investigative Site 606
state: Karnataka
city: Bangalore
country: India
facility: Forest Investigative Site 602
state: Karnataka
city: Bangalore
country: India
facility: Forest Investigative Site 604
state: Karnataka
city: Mangalore
country: India
facility: Forest Investigative Site 601
state: Karnataka
city: Palakkad
country: India
facility: Forest Investigative Site 619
state: Kerala
city: Nagpur
country: India
facility: Forest Investigative Site 616
state: Maharashtra
city: Nasik
country: India
facility: Forest Investigative Site 617
state: Maharashtra
city: Pune
country: India
facility: Forest Investigative Site 612
state: Maharashtra
city: Channi
country: India
facility: Forest Investigative Site 603
state: Tamil Nadu
city: Chennai
country: India
facility: Forest Investigative Site 613
state: Tamil Nadu
city: Vellore
country: India
facility: Forest Investigative Site 615
state: Tamil Nadu
city: Kaunas
country: Lithuania
facility: Forest Investigative Site 702
city: Kaunas
country: Lithuania
facility: Forest Investigative Site 703
city: Kaunas
country: Lithuania
facility: Forest Investigative Site 701
city: Klaipeda
country: Lithuania
facility: Forest Investigative Site 704
city: Vilnius
country: Lithuania
facility: Forest Investigative Site 705
city: Trujillo
country: Peru
facility: Forest Investigative Site 812
state: La Libertad
city: Chiclayo
country: Peru
facility: Forest Investigative Site 811
state: Lambayeque
city: Arequipa
country: Peru
facility: Forest Investigative Site 804
city: Arequipa
country: Peru
facility: Forest Investigative Site 803
city: Lima
country: Peru
facility: Forest Investigative Site 805
city: Lima
country: Peru
facility: Forest Investigative Site 813
city: Lima
country: Peru
facility: Forest Investigative Site 801
city: Lima
country: Peru
facility: Forest Investigative Site 807
city: Lima
country: Peru
facility: Forest Investigative Site 809
city: Lima
country: Peru
facility: Forest Investigative Site 808
city: Piura
country: Peru
facility: Forest Investigative Site 802
city: Bacau
country: Romania
facility: Forest Investigative Site 909
city: Bucuresti
country: Romania
facility: Forest Investigative Site 906
city: Bucuresti
country: Romania
facility: Forest Investigative Site 908
city: Satu Mare
country: Romania
facility: Forest Investigative Site 903
city: Sibiu
country: Romania
facility: Forest Investigative Site 901
city: Tg Mures
country: Romania
facility: Forest Investigative Site 905
city: Timisoara
country: Romania
facility: Forest Investigative Site 902
Study officials:
affiliation: Forest Research Institute, a subsidiary of Forest Laboratories Inc.
name: Kaity Posada, PharmD
role: STUDY_DIRECTOR
References: