Safety and Efficacy of Dutogliptin in Patients With Type 2 Diabetes Mellitus (T2DM) on Background Therapy With Pioglitazone

Phase 3

Terminated

Conditions: Diabetes Mellitus, Type II

Interventions: Drug: Placebo
Drug: Dutogliptin

Registration Number: NCT00970424

Lead Sponsor: Forest Laboratories

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 252

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Placebo	placebo, oral tablet administered once daily on background of pioglitazone
2	Dutogliptin	dutogliptin, oral tablet administered once daily on background of pioglitazone

Primary Outcome Measures

Name	Time	Method
Hemoglobin A1c Level (HbA1c)	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 Outcome Measures

Name	Time	Method
Fasting Plasma Glucose Level (FPG)	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).

Trial Locations

Locations (118): Forest Investigative Site 028
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Virginia Beach, Virginia, United States
Forest Investigative Site 032
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Kettering, Ohio, United States
Forest Investigative Site 099
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Arlington, Texas, United States
Forest Investigative Site 906
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Bucuresti, Romania
Forest Investigative Site 021
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Miami, Florida, United States
Forest Investigative Site 122
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Miami, Florida, United States
Forest Investigative Site 109
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San Antonio, Texas, United States
Forest Investigative Site 615
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Vellore, Tamil Nadu, India
Forest Investigative Site 053
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Kansas City, Kansas, United States
Forest Investigative Site 010
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Huntington Park, California, United States
Forest Investigative Site 073
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Clearwater, Florida, United States
Forest Investigative Site 050
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Miami, Florida, United States
Forest Investigative Site 067
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Sacramento, California, United States
Forest Investigative Site 015
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Orlando, Florida, United States
Forest Investigative Site 111
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Northridge, California, United States
Forest Investigative Site 091
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Roseville, California, United States
Forest Investigative Site 030
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Peoria, Illinois, United States
Forest Investigative Site 047
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Harbor City, California, United States
Forest Investigative Site 096
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Litchfield, Arizona, United States
Forest Investigative Site 061
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Anaheim, California, United States
Forest Investigative Site 004
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Daytona Beach, Florida, United States
Forest Investigative Site 052
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DeLand, Florida, United States
Forest Investigative Site 022
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Greenbrae, California, United States
Forest Investigative Site 115
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Colorado Springs, Colorado, United States
Forest Investigative Site 018
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Sarasota, Florida, United States
Forest Investigative Site 023
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Cincinnati, Ohio, United States
Forest Investigative Site 041
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Chula Vista, California, United States
Forest Investigative Site 097
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Evansville, Indiana, United States
Forest Investigative Site 002
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Dearborn, Michigan, United States
Forest Investigative Site 063
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West Hills, California, United States
Forest Investigative Site 072
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Las Vegas, Nevada, United States
Forest Investigative Site 076
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Salt Lake City, Utah, United States
Forest Investigative Site 057
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Dayton, Ohio, United States
Forest Investigative Site 009
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Meridian, Idaho, United States
Forest Investigative Site 081
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New Hyde Park, New York, United States
Forest Investigative Site 007
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Waltham, Massachusetts, United States
Forest Investigative Site 038
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Morehead City, North Carolina, United States
Forest Investigative Site 036
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Tipton, Pennsylvania, United States
Forest Investigative Site 104
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Chattanooga, Tennessee, United States
Forest Investigative Site 017
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Dallas, Texas, United States
Forest Investigative Site 100
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Evansville, Indiana, United States
Forest Investigative Site 013
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Grand Island, Nebraska, United States
Forest Investigative Site 054
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Edina, Minnesota, United States
Forest Investigative Site 149
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Norman, Oklahoma, United States
Forest Investigative Site 607
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Bangalore, Karnataka, India
Forest Investigative Site 056
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Corpus Christi, Texas, United States
Forest Investigative Site 008
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Wichita, Kansas, United States
Forest Investigative Site 094
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Charlotte, North Carolina, United States
Forest Investigative Site 040
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Salisbury, North Carolina, United States
Forest Investigative Site 043
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Columbus, Ohio, United States
Forest Investigative Site 065
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Las Vegas, Nevada, United States
Forest Investigative Site 033
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Pelzer, South Carolina, United States
Forest Investigative Site 058
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Lenoir, North Carolina, United States
Forest Investigative Site 092
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Spokane, Washington, United States
Forest Investigative Site 401
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Dresden, Germany
Forest Investigative Site 604
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Bangalore, Karnataka, India
Forest Investigative Site 064
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Birmingham, Alabama, United States
Forest Investigative Site 027
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Milwaukee, Wisconsin, United States
Forest Investigative Site 016
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New York, New York, United States
Forest Investigative Site 045
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Atlanta, Georgia, United States
Forest Investigative Site 60
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Melrose Park, Illinois, United States
Forest Investigative Site 024
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Madisonville, Kentucky, United States
Forest Investigative Site 029
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St. Clair Shores, Michigan, United States
Forest Investigative Site 102
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Ashland, Oregon, United States
Forest Investigative Site 124
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Dallas, Texas, United States
Forest Investigative Site 066
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Philadelphia, Pennsylvania, United States
Forest Investigative Site 020
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Birmingham, Alabama, United States
Forest Investigative Site 059
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Chandler, Arizona, United States
Forest Investigative Site 031
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Riverside, California, United States
Forest Investigative Site 049
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Encinitas, California, United States
Forest Investigative Site 011
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Walnut Creek, California, United States
Forest Investigative Site 112
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Santa Ana, California, United States
Forest Investigative Site 062
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Jacksonville, Florida, United States
Forest Investigative Site 075
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St. Petersburg, Florida, United States
Forest Investigative Site 079
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Augusta, Georgia, United States
Forest Investigative Site 026
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West Palm Beach, Florida, United States
Forest Investigative Site 078
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Erlanger, Kentucky, United States
Forest Investigative Site 035
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Baltimore, Maryland, United States
Forest Investigative Site 118
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New Bedford, Massachusetts, United States
Forest Investigative Site 046
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Oxon Hill, Maryland, United States
Forest Investigative Site 051
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Charlotte, North Carolina, United States
Forest Investigative Site 117
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Charlotte, North Carolina, United States
Forest Investigative Site 039
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Akron, Ohio, United States
Forest Investigative Site 037
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Harleysville, Pennsylvania, United States
Forest Investigative Site 005
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Eugene, Oregon, United States
Forest Investigative Site 103
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Greer, South Carolina, United States
Forest Investigative Site 106
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Houston, Texas, United States
Forest Investigative Site 014
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Irving, Texas, United States
Forest Investigative Site 209
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Mogilev, Belarus
Forest Investigative Site 403
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Mainz, Germany
Forest Investigative Site 402
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Dresden, Germany
Forest Investigative Site 614
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Vijayawada, Andhra Pradesh, India
Forest Investigative Site 618
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Ahmedabad, Gujarat, India
Forest Investigative Site 620
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Haryana, Karnal, India
Forest Investigative Site 606
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Bangalore, Karnataka, India
Forest Investigative Site 601
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Mangalore, Karnataka, India
Forest Investigative Site 602
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Bangalore, Karnataka, India
Forest Investigative Site 616
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Nagpur, Maharashtra, India
Forest Investigative Site 612
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Pune, Maharashtra, India
Forest Investigative Site 603
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Channi, Tamil Nadu, India
Forest Investigative Site 617
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Nasik, Maharashtra, India
Forest Investigative Site 613
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Chennai, Tamil Nadu, India
Forest Investigative Site 702
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Kaunas, Lithunia, Lithuania
Forest Investigative Site 703
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Kaunas, Lithunia, Lithuania
Forest Investigative Site 704
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Klaipeda, Lithunia, Lithuania
Forest Investigative Site 705
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Vilnius, Lithunia, Lithuania
Forest Investigative Site 909
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Bacau, Romania
Forest Investigative Site 908
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Bucuresti, Romania
Forest Investigative Site 905 Romania
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Tg Mures, Romania
Forest Investigative Site 903
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Satu Mare, Romania
Forest Investigative Site 901
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Sibiu, Romania
Forest Investigative Site 902
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Timisoara, Romania
Forest Investigative Site 098
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Phoenix, Arizona, United States
Forest Investigative Site 087
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Tucson, Arizona, United States
Forest Investigative Site 044
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Scottsdale, Arizona, United States
Forest Investigative Site 034
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Covington, Louisiana, United States
Forest Investigative Site 114
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Chattanooga, Tennessee, United States
Forest Investigative Site 090
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Manning, South Carolina, United States