CClinicalTrials.gg
TerminatedNCT00850239Updated Aug 11, 2010

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

A Phase 3 interventional study of dutogliptin and placebo in Type 2 Diabetes Mellitus, sponsored by Phenomix. Terminated at 97 sites in 7 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2010-08-11.

Sponsored by Phenomix · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
700
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Type 2 Diabetes Mellitus

Keywords

  • diabetes
  • DPP4 inhibitor
  • dutogliptin
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's planned enrollment of 700 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Phenomix is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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)

Exclusion criteria

Exclusion Criteria:

  • Type 1 diabetes mellitus
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
700 participants (estimated)

Study arms

  • Experimental
    1

    dutogliptin/PHX1149T

    Drug: dutogliptin

  • Placebo comparator
    2

    Plabeco

    Drug: placebo

Interventions

  • Drugdutogliptin

    400 mg

    Also known as: PHX1149T

  • Drugplacebo
06

What researchers measure

Primary outcomes

  1. Primary objective is to demonstrate the efficacy of dutogliptin, as evidenced by placebo-corrected changes in HbA1c relative to baseline.

    Time frame: 26 weeks

Secondary outcomes

  1. Demonstrate safety and tolerability of dutogliptin

    Time frame: 26 weeks

  2. • Demonstrate changes in fasting plasma glucose

    Time frame: 26 weeks

07

Study locations

97 sites
  • Phenomix Investigational Site 115
    Montgomery, Alabama, United States
  • 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 107
    Winston-Salem, North Carolina, United States
  • Phenomix Investigational Site 130
    Cincinnati, Ohio, United States
  • Phenomix Investigational Site 118
    Cuyahoga Falls, Ohio, United States
  • Phenomix Investigational Site 112
    Greenville, South Carolina, United States
  • Phenomix Investigational Site 102
    Dallas, Texas, United States
  • Phenomix Investigational Site 139
    Dallas, Texas, United States
  • Phenomix Investigational Site 126
    El Paso, Texas, United States
  • Phenomix Investigational Site 104
    San Antonio, Texas, United States
  • Phenomix Investigational Site 100
    Kenosha, Wisconsin, United States
  • Phenomix Investigational Site 401
    Buenos Aires, Argentina
  • Phenomix Investigational Site 402
    Buenos Aires, Argentina
  • Phenomix Investigational Site 404
    Buenos Aires, Argentina
  • Phenomix Investigational Site 405
    Buenos Aires, Argentina
  • Phenomix Investigational Site 406
    Buenos Aires, Argentina
  • Phenomix Investigational Site 407
    Buenos Aires, Argentina
  • Phenomix Investigational Site 408
    Buenos Aires, Argentina
  • Phenomix Investigational Site 409
    Buenos Aires, Argentina
  • Phenomix Investigational Site 411
    Buenos Aires, Argentina
  • Phenomix Investigational Site 403
    Corrientes, Argentina
  • Phenomix Investigational Site 410
    Mendoza, Argentina
  • Phenomix Investigational Site 400
    Rosario, Argentina
  • Phenomix Investigational Site 502
    Santiago, Chile
  • Phenomix Investigational Site 504
    Santiago, Chile
  • Phenomix Investigational Site 505
    Santiago, Chile
  • Phenomix Investigational Site 500
    Temuco, Chile
  • Phenomix Investigational Site 501
    Temuco, Chile
  • Phenomix Investigational Site 209
    Chodov, Czech Republic
  • Phenomix Investigational Site 205
    Havířov-Město, Czech Republic
  • Phenomix Investigational Site 204
    Liberec, Czech Republic
  • Phenomix Investigational Site 202
    Olomouc, Czech Republic
  • Phenomix Investigational Site 206
    Ostrava Kunčice, Czech Republic
  • Phenomix Investigational Site 208
    Praha, Czech Republic
  • Phenomix Investigational Site 203
    Prostějov, Czech Republic
  • Phenomix Investigational Site 207
    Uničov, Czech Republic
  • Phenomix Investigational Site 201
    Valašské Klobouky, Czech Republic
  • Phenomix Investigational Site 703
    Hyderabad, Andhara Pradesh, India
  • Phenomix Investigational Site 704
    Visakhapatanam, Andhra Pradesh, India
  • Phenomix Investigational Site 709
    Gopalapuram, Chennai, India
  • Phenomix Investigational Site 707
    Shastrinagar, Jaipur, India
  • Phenomix Investigational Site 701
    Bangalore, Karnataka, India
  • Phenomix Investigational Site 702
    Bangalore, Karnataka, India
  • Phenomix Investigational Site 705
    Trivandrum, Kerala, India
  • Phenomix Investigational Site 706
    Indore, Madhya Pradesh, India
  • Phenomix Investigational Site 700
    Nashik, Maharashtra, India
  • Phenomix Investigational Site 710
    Navi Mumbai, Maharashtra, India
  • Phenomix Investigational Site 711
    Mumbai, Maharastra, India
  • Phenomix Investigational Site 708
    Chennai, India
  • Phenomix Investigational Site 607
    Arequipa, Peru
  • Phenomix Investigational Site 605
    Cercado de Lima, Peru
  • Phenomix Investigational Site 601
    Ica, Peru
  • Phenomix Investigational Site 600
    Lima, Peru
  • Phenomix Investigational Site 603
    Lima, Peru
  • Phenomix Investigational Site 604
    Lima, Peru
  • Phenomix Investigational Site 608
    Lima, Peru
  • Phenomix Investigational Site 610
    Lima, Peru
  • Phenomix Investigational Site 606
    Piura, Peru
  • Phenomix Investigational Site 602
    Trujillo, Peru
  • Phenomix Investigational Site 609
    Wanchaq Cusco, Peru
  • Phenomix Investigational Site 300
    Gdańsk, Poland
  • Phenomix Investigational Site 301
    Gdańsk, Poland
  • Phenomix Investigational Site 303
    Katowice, Poland
  • Phenomix Investigational Site 312
    Katowice, Poland
  • Phenomix Investigational Site 309
    Kraków, Poland
  • Phenomix Investigational Site 313
    Kraków, Poland
  • Phenomix Investigational Site 308
    Lublin, Poland
  • Phenomix Investigational Site 310
    Poznan, Poland
  • Phenomix Investigational Site 306
    Puławy, Poland
  • Phenomix Investigational Site 304
    Szczecin, Poland
  • Phenomix Investigational Site 305
    Warszawa, Poland
  • Phenomix Investigational Site 307
    Warszawa, Poland
  • Phenomix Investigational Site 311
    Warszawa, Poland
  • Phenomix Investigational Site 302
    Wrocław, Poland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 11, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00850239
Lead sponsor
Phenomix
Collaborators
Forest Laboratories
First posted
Feb 24, 2009
Start date
May 2009
Primary completion
Oct 2010 (estimated)
Completion
Dec 2010 (estimated)
Last update
Aug 11, 2010

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2010. You cannot join it, but the record below documents what was studied.

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