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

Last updated: February 1, 2010
Sponsor: Phenomix
Overall Status: Terminated

Phase

3

Condition

Diabetes Mellitus, Type 2

Nephropathy

Focal Segmental Glomerulosclerosis

Treatment

N/A

Clinical Study ID

NCT00958269
PHX1149-PROT306
  • Ages 18-85
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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.

Exclusion

Exclusion Criteria:

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

  • Kidney transplant

Study Design

Total Participants: 360
Study Start date:
August 01, 2009
Estimated Completion Date:
November 30, 2011

Connect with a study center

  • Phenomix Investigational Site 208

    Kemerovo,
    Russian Federation

    Site Not Available

  • Phenomix Investigational Site 203

    Moscow,
    Russian Federation

    Site Not Available

  • Phenomix Investigational Site 204

    Moscow,
    Russian Federation

    Site Not Available

  • Phenomix Investigational Site 209

    Moscow,
    Russian Federation

    Site Not Available

  • Phenomix Investigational Site 211

    Moscow,
    Russian Federation

    Site Not Available

  • Phenomix Investigational Site 205

    Novosibirsk,
    Russian Federation

    Site Not Available

  • Phenomix Investigational Site 207

    Perm.,
    Russian Federation

    Site Not Available

  • Phenomix Investigational Site 206

    Petrozavodsk,
    Russian Federation

    Site Not Available

  • Phenomix Investigational Site 200

    St. Petersburg,
    Russian Federation

    Site Not Available

  • Phenomix Investigational Site 201

    St. Petersburg,
    Russian Federation

    Site Not Available

  • Phenomix Investigational Site 210

    St. Petersburg,
    Russian Federation

    Site Not Available

  • Phenomix Investigational Site 212

    St. Petersburg,
    Russian Federation

    Site Not Available

  • Phenomix Investigational Site 213

    St. Petersburg,
    Russian Federation

    Site Not Available

  • Phenomix Investigational Site 304

    Chernivtsi,
    Ukraine

    Site Not Available

  • Phenomix Investigational Site 300

    Kyiv,
    Ukraine

    Site Not Available

  • Phenomix Investigational Site 301

    Kyiv,
    Ukraine

    Site Not Available

  • Phenomix Investigational Site 306

    Kyiv,
    Ukraine

    Site Not Available

  • Phenomix Investigational Site 302

    Odesa,
    Ukraine

    Site Not Available

  • Phenomix Investigational Site 303

    Vinnytsa,
    Ukraine

    Site Not Available

  • Phenomix Investigational Site 307

    Zaporizhzhya,
    Ukraine

    Site Not Available

  • Phenomix Investigational Site 115

    Tempe, Arizona
    United States

    Site Not Available

  • Phenomix Investigational Site 121

    Long Beach, California
    United States

    Site Not Available

  • Phenomix Investigational Site 110

    Lynwood, California
    United States

    Site Not Available

  • Phenomix Investigational Site 118

    Lynwood, California
    United States

    Site Not Available

  • Phenomix Investigational Site 119

    Orange, California
    United States

    Site Not Available

  • Phenomix Investigational Site 109

    Palm Springs, California
    United States

    Site Not Available

  • Phenomix Investigational Site 122

    Whittier, California
    United States

    Site Not Available

  • Phenomix Investigational Site 112

    Lauderdale Lakes, Florida
    United States

    Site Not Available

  • Phenomix Investigational Site 104

    Ocala, Florida
    United States

    Site Not Available

  • Phenomix Investigational Site 116

    Pembroke Pines, Florida
    United States

    Site Not Available

  • Phenomix Investigational Site 101

    Augusta, Georgia
    United States

    Site Not Available

  • Phenomix Investigational Site 117

    Honolulu, Hawaii
    United States

    Site Not Available

  • Phenomix Investigational Site 102

    Baton Rouge, Louisiana
    United States

    Site Not Available

  • Phenomix Investigational Site 100

    Rockville, Maryland
    United States

    Site Not Available

  • Phenomix Investigational Site 125

    Rockville, Maryland
    United States

    Site Not Available

  • Phenomix Investigational Site 114

    Springfield Gardens, New York
    United States

    Site Not Available

  • Phenomix Investigational Site 120

    Winston-Salem, North Carolina
    United States

    Site Not Available

  • Phenomix Investigational Site 107

    Columbia, South Carolina
    United States

    Site Not Available

  • Phenomix Investigational Site 111

    Nashville, Tennessee
    United States

    Site Not Available

  • Phenomix Investigational Site 103

    Fort Worth, Texas
    United States

    Site Not Available

  • Phenomix Investigational Site 106

    Houston, Texas
    United States

    Site Not Available

  • Phenomix Investigational Site 108

    San Antonio, Texas
    United States

    Site Not Available

  • Phenomix Investigational Site 113

    Alexandria, Virginia
    United States

    Site Not Available

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