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

Condition(s) targeted: Diabetes Mellitus, Type II

Intervention: Dutogliptin (Drug); Placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Forest Laboratories

Official(s) and/or principal investigator(s):
Kaity Posada, PharmD, Study Director, Affiliation: Forest Research Institute, a subsidiary of Forest Laboratories Inc.

Overall contact:
Sandra Beaird, PhD, Phone: 1-800-678-1605, Ext: 66297, Email: info@forestpharm.com

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.

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 design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Hemoglobin A1c (HbA1c)

Secondary outcome: Fasting Plasma Glucose (FPG)

Minimum age: 18 Years. Maximum age: 85 Years. Gender(s): Both.

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

Sandra Beaird, PhD, Phone: 1-800-678-1605, Ext: 66297, Email: info@forestpharm.com

Forest Investigative Site 020, Birmingham, Alabama 35235, United States; Recruiting

Forest Investigative Site 025, Muscle Shoals, Alabama 35661, United States; Not yet recruiting

Forest Investigative Site 064, Birmingham, Alabama 35205, United States; Recruiting

Forest Investigative Site 044, Scottsdale, Arizona 85254, United States; Recruiting

Forest Investigative Site 059, Chandler, Arizona 85225, United States; Recruiting

Forest Investigative Site 080, Peoria, Arizona 85381, United States; Not yet recruiting

Forest Investigative Site 010, Huntington Park, California 90255, United States; Recruiting

Forest Investigative Site 011, Walnut Creek, California 94598, United States; Not yet recruiting

Forest Investigative Site 022, Greenbrae, California 94904, United States; Not yet recruiting

Forest Investigative Site 031, Riverside, California 92506, United States; Not yet recruiting

Forest Investigative Site 041, Chula Vista, California 91911, United States; Not yet recruiting

Forest Investigative Site 047, Harbor City, California 90710, United States; Not yet recruiting

Forest Investigative Site 049, Encinitas, California 92024, United States; Recruiting

Forest Investigative Site 061, Anaheim, California 92801, United States; Recruiting

Forest Investigative Site 063, West Hills, California 91307, United States; Not yet recruiting

Forest Investigative Site 067, Sacramento, California 95821, United States; Recruiting

Forest Investigative Site 070, Los Angeles, California 90057, United States; Recruiting

Forest Investigative Site 088, Denver, Colorado 80239, United States; Not yet recruiting

Forest Investigative Site 004, Daytona Beach, Florida 32117, United States; Recruiting

Forest Investigative Site 012, Ocala, Florida 34471, United States; Recruiting

Forest Investigative Site 015, Orlando, Florida 32806, United States; Recruiting

Forest Investigative Site 018, Sarasota, Florida 34239, United States; Not yet recruiting

Forest Investigative Site 021, Miami, Florida 33169, United States; Not yet recruiting

Forest Investigative Site 026, West Palm Beach, Florida 33401, United States; Not yet recruiting

Forest Investigative Site 050, Miami, Florida 33156, United States; Not yet recruiting

Forest Investigative Site 052, DeLand, Florida 32720, United States; Not yet recruiting

Forest Investigative Site 062, Jacksonville, Florida 32205, United States; Recruiting

Forest Investigative Site 069, New Port Richey, Florida 34652, United States; Recruiting

Forest Investigative Site 042, Dunwoody, Georgia 30338, United States; Not yet recruiting

Forest Investigative Site 045, Atlanta, Georgia 30338, United States; Recruiting

Forest Investigative Site 077, Decatur, Georgia 30035, United States; Not yet recruiting

Forest Investigative Site 079, Augusta, Georgia 30909, United States; Recruiting

Forest Investigative Site 084, Roswell, Georgia 30076, United States; Not yet recruiting

Forest Investigative Site 009, Meridian, Idaho 83646, United States; Recruiting

Forest Investigative Site 030, Peoria, Illinois 61614, United States; Not yet recruiting

Forest Investigative Site 060, Melrose Park, Illinois 60160, United States; Not yet recruiting

Forest Investigative Site 008, Wichita, Kansas 67203, United States; Recruiting

Forest Investigative Site 053, Kansas City, Kansas 66160, United States; Not yet recruiting

Forest Investigative Site 024, Madisonville, Kentucky 42430, United States; Not yet recruiting

Forest Investigative Site 078, Erlanger, Kentucky 41018, United States; Not yet recruiting

Forest Investigative Site 034, Covington, Louisiana 70433, United States; Recruiting

Forest Investigative Site 035, Baltimore, Maryland 21204, United States; Not yet recruiting

Forest Investigative Site 046, Oxon Hill, Maryland 20745, United States; Not yet recruiting

Forest Investigative Site 003, Brockton, Massachusetts 02301, United States; Recruiting

Forest Investigative Site 007, Waltham, Massachusetts 24453, United States; Recruiting

Forest Investigative Site 055, Brockton, Massachusetts 23301, United States; Recruiting

Forest Investigative Site 002, Dearborn, Michigan 48126, United States; Not yet recruiting

Forest Investigative Site 029, St. Clair Shores, Michigan 48081, United States; Recruiting

Forest Investigative Site 054, Edina, Minnesota 55435, United States; Recruiting

Forest Investigative Site 085, Florissant, Missouri 63031, United States; Recruiting

Forest Investigative Site 089, St. Louis, Missouri 63141, United States; Not yet recruiting

Forest Investigative Site 013, Grand Island, Nebraska 68803, United States; Recruiting

Forest Investigative Site 065, Las Vegas, Nevada 89117, United States; Recruiting

Forest Investigative Site 072, Las Vegas, Nevada 89101, United States; Recruiting

Forest Investigative Site 006, Albany, New York 12206, United States; Recruiting

Forest Investigative Site 016, New York, New York 10019, United States; Recruiting

Forest Investigative Site 081, New Hyde Park, New York 11042, United States; Not yet recruiting

Forest Investigative Site 038, Morehead City, North Carolina 28557, United States; Not yet recruiting

Forest Investigative Site 040, Salisbury, North Carolina 28144, United States; Recruiting

Forest Investigative Site 051, Charlotte, North Carolina 28209, United States; Recruiting

Forest Investigative Site 058, Lenoir, North Carolina 28645, United States; Not yet recruiting

Forest Investigative Site 082, Winston-Salem, North Carolina 27103, United States; Not yet recruiting

Forest Investigative Site 019, Wadsworth, Ohio 44281, United States; Recruiting

Forest Investigative Site 023, Cincinnati, Ohio 45242, United States; Recruiting

Forest Investigative Site 032, Kettering, Ohio 45429, United States; Not yet recruiting

Forest Investigative Site 039, Akron, Ohio 44311, United States; Not yet recruiting

Forest Investigative Site 043, Columbus, Ohio 43201, United States; Not yet recruiting

Forest Investigative Site 057, Dayton, Ohio 45406, United States; Not yet recruiting

Forest Investigative Site 083, Bethany, Oklahoma 73008, United States; Not yet recruiting

Forest Investigative Site 001, Medford, Oregon 97504, United States; Not yet recruiting

Forest Investigative Site 005, Eugene, Oregon 97404, United States; Recruiting

Forest Investigative Site 036, Tipton, Pennsylvania 16684, United States; Recruiting

Forest Investigative Site 037, Harleysville, Pennsylvania 19438, United States; Recruiting

Forest Investigative Site 066, Philadelphia, Pennsylvania 19152, United States; Recruiting

Forest Investigative Site 033, Pelzer, South Carolina 29669, United States; Recruiting

Forest Investigative Site 048, Bristol, Tennessee 37620, United States; Recruiting

Forest Investigative Site 014, Irving, Texas 75039, United States; Not yet recruiting

Forest Investigative Site 017, Dallas, Texas 75235, United States; Not yet recruiting

Forest Investigative Site 056, Corpus Christi, Texas 78404, United States; Recruiting

Forest Investigative Site 071, Dallas, Texas 75230, United States; Recruiting

Forest Investigative Site 086, San Antonio, Texas 78258, United States; Not yet recruiting

Forest Investigative Site 076, Salt Lake City, Utah 84107, United States; Not yet recruiting

Forest Investigative Site 028, Virginia Beach, Virginia 23454, United States; Not yet recruiting

Forest Investigative Site 068, Renton, Washington 98057, United States; Not yet recruiting

Forest Investigative Site 027, Milwaukee, Wisconsin 53209, United States; Not yet recruiting

Starting date: July 2009
Last updated: September 1, 2009