Clinical trial NCT00970424: Safety and Efficacy of Dutogliptin in Patients With Type 2 Diabetes Mellitus (T2DM) on Background Therapy With Pioglitazone
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 Pioglitazone
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: 2009-09-02
Enrollment: 252
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 treatment with pioglitazone.


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 taking more than one oral hypoglycemic agent
* Type 1 diabetes mellitus

Primary outcomes:
measure: Hemoglobin A1c Level (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) and Week 8 (Week 26)
Secondary outcomes:
measure: Fasting Plasma Glucose Level (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) and 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: Chandler
country: United States
facility: Forest Investigative Site 059
state: Arizona
city: Litchfield
country: United States
facility: Forest Investigative Site 096
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: Tucson
country: United States
facility: Forest Investigative Site 087
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: 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: Colorado Springs
country: United States
facility: Forest Investigative Site 115
state: Colorado
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: Jacksonville
country: United States
facility: Forest Investigative Site 062
state: Florida
city: Miami
country: United States
facility: Forest Investigative Site 021
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: Orlando
country: United States
facility: Forest Investigative Site 015
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: Meridian
country: United States
facility: Forest Investigative Site 009
state: Idaho
city: Melrose Park
country: United States
facility: Forest Investigative Site 60
state: Illinois
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: Erlanger
country: United States
facility: Forest Investigative Site 078
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: 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: Grand Island
country: United States
facility: Forest Investigative Site 013
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: 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: Charlotte
country: United States
facility: Forest Investigative Site 117
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: 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: 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: Harleysville
country: United States
facility: Forest Investigative Site 037
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: 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 017
state: Texas
city: Dallas
country: United States
facility: Forest Investigative Site 124
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: San Antonio
country: United States
facility: Forest Investigative Site 109
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: Spokane
country: United States
facility: Forest Investigative Site 092
state: Washington
city: Milwaukee
country: United States
facility: Forest Investigative Site 027
state: Wisconsin
city: Mogilev
country: Belarus
facility: Forest Investigative Site 209
city: Dresden
country: Germany
facility: Forest Investigative Site 401
city: Dresden
country: Germany
facility: Forest Investigative Site 402
city: Mainz
country: Germany
facility: Forest Investigative Site 403
city: Vijayawada
country: India
facility: Forest Investigative Site 614
state: Andhra Pradesh
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: 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
state: Lithunia
city: Kaunas
country: Lithuania
facility: Forest Investigative Site 703
state: Lithunia
city: Klaipeda
country: Lithuania
facility: Forest Investigative Site 704
state: Lithunia
city: Vilnius
country: Lithuania
facility: Forest Investigative Site 705
state: Lithunia
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 Romania
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: