Study to Evaluate Safety and Efficacy of Dutogliptin in Type 2 Diabetes Mellitus Subjects With Moderate and Severe Renal Impairment

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Type 2 Diabetes Mellitus, Renal Impairment

In brief

The purpose of this study is to assess the safety and tolerability of dutogliptin in Type 2 diabetic subjects with moderate or severe renal impairment.

Key facts

Study ID

NCT00958269

Run by

Phenomix

People needed

360

Starts

2009-08-01

Expected to finish

2011-11-01

Last updated by the study team

2010-02-03

Who can join

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

You may qualify if…

• Type 2 diabetes mellitus
• Renal impairment (moderate and severe)
• Currently on stable doses of background medication of SU, TZD, acarbose, meglitinide, insulin or any combination thereof, or on no antidiabetic drugs at all
• HbA1c 7.0% - 10.5%, inclusive
• Male or female subjects between the ages of 18 and 85 years, inclusive.

You may not qualify if…

• Type 1 diabetes mellitus or history of diabetic ketoacidosis, mature onset diabetes of the young (MODY)
• Kidney transplant

Where it is running

• Phenomix Investigational Site 115 — Tempe, Arizona, United States
• Phenomix Investigational Site 121 — Long Beach, California, United States
• Phenomix Investigational Site 110 — Lynwood, California, United States
• Phenomix Investigational Site 118 — Lynwood, California, United States
• Phenomix Investigational Site 119 — Orange, California, United States
• Phenomix Investigational Site 109 — Palm Springs, California, United States
• Phenomix Investigational Site 122 — Whittier, California, United States
• Phenomix Investigational Site 112 — Lauderdale Lakes, Florida, United States
• Phenomix Investigational Site 104 — Ocala, Florida, United States
• Phenomix Investigational Site 116 — Pembroke Pines, Florida, United States
• Phenomix Investigational Site 101 — Augusta, Georgia, United States
• Phenomix Investigational Site 117 — Honolulu, Hawaii, United States
• Phenomix Investigational Site 102 — Baton Rouge, Louisiana, United States
• Phenomix Investigational Site 100 — Rockville, Maryland, United States
• Phenomix Investigational Site 125 — Rockville, Maryland, United States
• Phenomix Investigational Site 114 — Springfield Gardens, New York, United States
• Phenomix Investigational Site 120 — Winston-Salem, North Carolina, United States
• Phenomix Investigational Site 107 — Columbia, South Carolina, United States
• Phenomix Investigational Site 111 — Nashville, Tennessee, United States
• Phenomix Investigational Site 103 — Fort Worth, Texas, United States
• Phenomix Investigational Site 106 — Houston, Texas, United States
• Phenomix Investigational Site 108 — San Antonio, Texas, United States
• Phenomix Investigational Site 113 — Alexandria, Virginia, United States
• Phenomix Investigational Site 208 — Kemerovo, Russia
• Phenomix Investigational Site 203 — Moscow, Russia

Full record on ClinicalTrials.gov

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