Safety and Efficacy Study of Dutogliptin/PHX1149T in Subjects With Type 2 Diabetes Mellitus on a Background Medication of Metformin

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Type 2 Diabetes Mellitus

In brief

The purpose of this study is to demonstrate the efficacy of dutogliptin over 26 weeks (as evidenced by placebo-corrected changes in HbA1c relative to baseline), to demonstrate safety and tolerability of dutogliptin, and to demonstrate changes in fasting plasma glucose over 26 weeks.

Key facts

Study ID

NCT00850239

Run by

Phenomix

People needed

700

Starts

2009-05-01

Expected to finish

2010-12-01

Last updated by the study team

2010-08-11

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Type 2 diabetes mellitus, diagnosed at least 4 months prior to Screening (Visit 1)
• Age 18 to 85 years, inclusive.
• Male and non-pregnant, non-lactating (and not planning to become pregnant during the study) female subjects with a BMI of 20 to 48 kg/m2, inclusive
• Current treatment of Type 2 diabetes mellitus with a stable dose of metformin of ≥ 2000 mg (or the highest tolerated dose) used in accordance with product labeling for at least 6 weeks prior to screening (Visit 1)
• HbA1c 7.0% - 10.0%, inclusive; and fasting plasma C peptide greater than 0.26 nmol/L (> 0.8 ng/mL; > 281 pmol/L) at screening (Visit 1)

You may not qualify if…

• Type 1 diabetes mellitus

Where it is running

• Phenomix Investigational Site 121 — Tempe, Arizona, United States
• Phenomix Investigational Site 137 — Tempe, Arizona, United States
• Phenomix Investigational Site 105 — Anaheim, California, United States
• Phenomix Investigational Site 123 — Chico, California, United States
• Phenomix Investigational Site 134 — Escondido, California, United States
• Phenomix Investigational Site 103 — Long Beach, California, United States
• Phenomix Investigational Site 106 — Los Angeles, California, United States
• Phenomix Investigational Site 143 — Coral Gables, Florida, United States
• Phenomix Investigational Site 142 — Hialeah, Florida, United States
• Phenomix Investigational Site 119 — Jacksonville, Florida, United States
• Phenomix Investigational Site 133 — Kissimmee, Florida, United States
• Phenomix Investigational Site 141 — Dunwoody, Georgia, United States
• Phenomix Investigational Site 101 — Honolulu, Hawaii, United States
• Phenomix Investigational Site 135 — Chicago, Illinois, United States
• Phenomix Investigational Site 124 — Indianapolis, Indiana, United States
• Phenomix Investigational Site 127 — Indianapolis, Indiana, United States
• Phenomix Investigational Site 136 — Brockton, Massachusetts, United States
• Phenomix Investigational Site 125 — Kalamazoo, Michigan, United States
• Phenomix Investigational Site 138 — Biloxi, Mississippi, United States
• Phenomix Investigational Site 122 — Las Vegas, Nevada, United States
• Phenomix Investigational Site 140 — Las Vegas, Nevada, United States
• Phenomix Investigational Site 131 — Brick, New Jersey, United States
• Phenomix Investigational Site 110 — Trenton, New Jersey, United States
• Phenomix Investigational Site 116 — Albuquerque, New Mexico, United States
• Phenomix Investigational Site 115 — Montgomery, Alabama, United States

Full record on ClinicalTrials.gov

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