Safety and Efficacy of Dutogliptin in Patients With Type 2 Diabetes Mellitus (T2DM) on Background Therapy With Glimepiride With or Without Metformin

Phase 3

Terminated

Conditions: Diabetes Mellitus, Type II

Interventions: Drug: Placebo
Drug: Dutogliptin

Registration Number: NCT00947557

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 therapy of glimepiride with or without metformin.

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 677

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
Dutogliptin	Dutogliptin	Dutogliptin

Primary Outcome Measures

Name	Time	Method
Hemoglobin A1c (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), Visit 8 (Week 26).

Secondary Outcome Measures

Name	Time	Method
Fasting Plasma Glucose (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), Visit 8 (Week 26).

Trial Locations

Locations (147): Forest Investigative Site 061
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Anaheim, California, United States
Forest Investigative Site 156
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Boca Raton, Florida, United States
Forest Investigative Site 018
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Sarasota, Florida, United States
Forest Investigative Site 045
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Atlanta, Georgia, United States
Forest Investigative Site 046
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Oxon Hill, Maryland, United States
Forest Investigative Site 032
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Kettering, Ohio, United States
Forest Investigative Site 001
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Medford, Oregon, United States
Forest Investigative Site 066
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Philadelphia, Pennsylvania, United States
Forest Investigative Site 114
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Chattanooga, Tennessee, United States
Forest Investigative Site 056
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Corpus Christi, Texas, United States
Forest Investigative Site 612
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Pune, Maharashtra, India
Forest Investigative Site 017
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Dallas, Texas, United States
Forest Investigative Site 113
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Gilbert, Arizona, United States
Forest Investigative Site 070
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Los Angeles, California, United States
Forest Investigative Site 049
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Encinitas, California, United States
Forest Investigative Site 096
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Litchfield, Arizona, United States
Forest Investigative Site 112
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Santa Ana, California, United States
Forest Investigative Site 091
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Roseville, California, United States
Forest Investigative Site 025
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Muscle Shoals, Alabama, United States
Forest Investigative Site 122
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Miami, Florida, United States
Forest Investigative Site 004
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Daytona Beach, Florida, United States
Forest Investigative Site 044
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Scottsdale, Arizona, United States
Forest Investigative Site 063
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West Hills, California, United States
Forest Investigative Site 059
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Chandler, Arizona, United States
Forest Investigative Site 125
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Miami Lakes, Florida, United States
Forest Investigative Site 107
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Lexington, Kentucky, United States
Forest Investigative Site 053
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Kansas City, Kansas, United States
Forest Investigative Site 054
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Edina, Minnesota, United States
Forest Investigative Site 079
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Augusta, Georgia, United States
Forest Investigative Site 035
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Baltimore, Maryland, United States
Forest Investigative Site 026
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West Palm Beach, Florida, United States
Forest Investigative Site 094
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Charlotte, North Carolina, United States
Forest Investigative Site 111
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Northridge, California, United States
Forest Investigative Site 030
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Peoria, Illinois, United States
Forest Investigative Site 010
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Huntington Park, California, United States
Forest Investigative Site 055
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Brockton, Massachusetts, United States
Forest Investigative Site 029
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St. Clair Shores, Michigan, United States
Forest Investigative Site 051
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Charlotte, North Carolina, United States
Forest Investigative Site 057
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Dayton, Ohio, United States
Forest Investigative Site 012
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Ocala, Florida, United States
Forest Investigative Site 097
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Evansville, Indiana, United States
Forest Investigative Site 009
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Meridian, Idaho, United States
Forest Investigative Site 002
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Dearborn, Michigan, United States
Forest Investigative Site 118
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New Bedford, Massachusetts, United States
Forest Investigative Site 016
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New York, New York, United States
Forest Investigative Site 131
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Ormond Beach, Florida, United States
Forest Investigative Site 039
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Akron, Ohio, United States
Forest Investigative Site 081
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New Hyde Park, New York, United States
Forest Investigative Site 100
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Evansville, Indiana, United States
Forest Investigative Site 043
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Columbus, Ohio, United States
Forest Investigative Site 005
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Eugene, Oregon, United States
Forest Investigative Site 083
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Bethany, Oklahoma, United States
Forest Investigative Site 050
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Miami, Florida, United States
Forest Investigative Site 021
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Miami, Florida, United States
Forest Investigative Site 072
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Las Vegas, Nevada, United States
Forest Investigative Site 065
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Las Vegas, Nevada, United States
Forest Investigative Site 023
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Cincinnati, Ohio, United States
Forest Investigative Site 109
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San Antonio, Texas, United States
Forest Investigative Site 119
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San Antonio, Texas, United States
Forest Investigative Site 613
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Chennai, Tamil Nadu, India
Forest Investigative Site 615
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Vellore, Tamil Nadu, India
Forest Investigative Site 202
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Gomel, Belarus
Forest Investigative Site 620
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Haryana, Karnal, India
Forest Investigative Site 618
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Ahmedabad, Gujarat, India
Forest Investigative Site 804
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Arequipa, Peru
Forest Investigative Site 098
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Phoenix, Arizona, United States
Forest Investigative Site 076
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Salt Lake City, Utah, United States
Forest Investigative Site 064
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Birmingham, Alabama, United States
Forest Investigative Site 020
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Birmingham, Alabama, United States
Forest Investigative Site 088
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Denver, Colorado, United States
Forest Investigative Site 075
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St. Petersburg, Florida, United States
Forest Investigative Site 038
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Morehead City, North Carolina, United States
Forest Investigative Site 031
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Riverside, California, United States
Forest Investigative Site 129
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Hollywood, Florida, United States
Forest Investigative Site 052
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DeLand, Florida, United States
Forest Investigative Site 011
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Walnut Creek, California, United States
Forest Investigative Site 041
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Chula Vista, California, United States
Forest Investigative Site 022
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Greenbrae, California, United States
Forest Investigative Site 047
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Harbor City, California, United States
Forest Investigative Site 080
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Peoria, Arizona, United States
Forest Investigative Site 127
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Pembroke Pines, Florida, United States
Forest Investigative Site 069
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New Port Richey, Florida, United States
Forest Investigative Site 062
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Jacksonville, Florida, United States
Forest Investigative Site 084
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Roswell, Georgia, United States
Forest Investigative Site 008
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Wichita, Kansas, United States
Forest Investigative Site 132
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Roswell, Georgia, United States
Forest Investigative Site 034
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Covington, Louisiana, United States
Forest Investigative Site 003
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Brockton, Massachusetts, United States
Forest Investigative Site 007
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Waltham, Massachusetts, United States
Forest Investigative Site 101
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Albuquerque, New Mexico, United States
Forest Investigative Site 058
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Lenoir, North Carolina, United States
Forest Investigative Site 126
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Jenkintown, Pennsylvania, United States
Forest Investigative Site 103
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Greer, South Carolina, United States
Forest Investigative Site 036
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Tipton, Pennsylvania, United States
Forest Investigative Site 033
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Pelzer, South Carolina, United States
Forest Investigative Site 104
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Chattanooga, Tennessee, United States
Forest Investigative Site 099
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Arlington, Texas, United States
Forest Investigative Site 014
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Irving, Texas, United States
Forest Investigative Site 071
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Dallas, Texas, United States
Forest Investigative Site 028
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Virginia Beach, Virginia, United States
Forest Investigative Site 068
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Renton, Washington, United States
Forest Investigative Site 207
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Minsk, Belarus
Forest Investigative Site 209
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Mogilev, Belarus
Forest Investigative Site 302
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Medellin, Antioquia, Colombia
Forest Investigative Site 504
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Szentes, Hungary
Forest Investigative Site 506
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Budapest, Hungary
Forest Investigative Site 621
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Hyderabad, Andhra Pradesh, India
Forest Investigative Site 614
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Vijayawada, Andhra Pradesh, India
Forest Investigative Site 607
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Bangalore, Karnataka, India
Forest Investigative Site 609
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Mapusa, Goa, India
Forest Investigative Site 606
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Bangalore, Karnataka, India
Forest Investigative Site 604
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Bangalore, Karnataka, India
Forest Investigative Site 704
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Klaipeda, Lithuania
Forest Investigative Site 603
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Channi, Tamil Nadu, India
Forest Investigative Site 702
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Kaunas, Lithuania
Forest Investigative Site 703
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Kaunas, Lithuania
Forest Investigative Site 701
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Kaunas, Lithuania
Forest Investigative Site 805
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Lima, Peru
Forest Investigative Site 812
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Trujillo, La Libertad, Peru
Forest Investigative Site 811
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Chiclayo, Lambayeque, Peru
Forest Investigative Site 813
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Lima, Peru
Forest Investigative Site 808
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Lima, Peru
Forest Investigative Site 802
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Piura, Peru
Forest Investigative Site 906
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Bucuresti, Romania
Forest Investigative Site 901
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Sibiu, Romania
Forest Investigative Site 617
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Nasik, Maharashtra, India
Forest Investigative Site 610
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Visakhapatanam, Andhra Pradesh, India
Forest Investigative Site 602
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Bangalore, Karnataka, India
Forest Investigative Site 909
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Bacau, Romania
Forest Investigative Site 616
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Nagpur, Maharashtra, India
Forest Investigative Site 208
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Grodno, Belarus
Forest Investigative Site 619
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Palakkad, Kerala, India
Forest Investigative Site 705
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Vilnius, Lithuania
Forest Investigative Site 803
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Arequipa, Peru
Forest Investigative Site 807
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Lima, Peru
Forest Investigative Site 809
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Lima, Peru
Forest Investigative Site 902
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Timisoara, Romania
Forest Investigative Site 206
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Vitebsk, Belarus
Forest Investigative Site 601
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Mangalore, Karnataka, India
Forest Investigative Site 801
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Lima, Peru
Forest Investigative Site 908
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Bucuresti, Romania
Forest Investigative Site 903
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Satu Mare, Romania
Forest Investigative Site 905
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Tg Mures, Romania
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 082
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Winston-Salem, North Carolina, United States
Forest Investigative Site 040
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Salisbury, North Carolina, United States