CClinicalTrials.gg
TerminatedNCT01089790REDWOOD403Updated Sep 21, 2011

Safety and Efficacy of Dutogliptin in Patients With Type 2 Diabetes Mellitus Receiving Background Treatment With Glimepiride Alone or in Combination With Metformin or With Pioglitazone Alone

A Phase 3 interventional study of Dutogliptin and Sitagliptin in Diabetes Mellitus, Type 2, sponsored by Forest Laboratories. Terminated at 149 sites in United States. Open to participants aged 18 Years to 86 Years. Per ClinicalTrials.gov, last updated 2011-09-21.

Sponsored by Forest Laboratories · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
141
Allocation
Non-randomized
Ages
18 Years to 86 Years
Sex
All
01

Study summary

This study will evaluate the long-term safety and efficacy of dutogliptin in patients with type 2 diabetes mellitus (T2DM).

02

Conditions studied

  • Diabetes Mellitus, Type 2
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.

This study's enrollment of 141 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Forest Laboratories is the lead sponsor of 165 studies on the registry; none are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.

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

04

Who can participate

Ages eligible
18 Years to 86 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Have successfully completed all required visits of a qualifying Phase 3 core protocol
  • Be currently receiving treatment for T2DM as set forth in the qualifying Phase 3 core protocol

Exclusion criteria

Exclusion Criteria:

  • Any condition, disease, disorder or clinically relevant laboratory abnormality which, in the opinion of the investigator, would jeopardize the patient's appropriate participation in this study or obscure the effects of treatment
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
141 participants (actual)

Study arms

  • Experimental
    1

    Drug: Dutogliptin

  • Active comparator
    2

    Drug: Sitagliptin

Interventions

  • DrugDutogliptin

    400 mg tablet, once daily

    Also known as: PHX1149

  • DrugSitagliptin

    100 mg capsule (each capsule contains two 50-mg tablets), once daily

    Also known as: Januvia

06

What researchers measure

Primary outcomes

  1. To demonstrate safety and tolerability of dutogliptin as assessed by vital signs, adverse event reporting, routine clinical laboratory assessments, and ECG

    Time frame: 52 weeks

Secondary outcomes

  1. To demonstrate maintenance or lowering of HbA1c and fasting plasma glucose.

    Time frame: 52 weeks

07

Study locations

149 sites
  • Forest Investigative Site 064
    Birmingham, Alabama 35205, United States
  • Forest Investigative Site 020
    Birmingham, Alabama 35235, United States
  • Forest Investigative Site 025
    Muscle Shoals, Alabama 35661, United States
  • Forest Investigative Site 059
    Chandler, Arizona 85225, United States
  • Forest Investigative Site 113
    Gilbert, Arizona 85295, United States
  • Forest Investigative Site 096
    Goodyear, Arizona 85395, United States
  • Forest Investigative Site 080
    Peoria, Arizona 85381, United States
  • Forest Investigative Site 098
    Phoenix, Arizona 85020, United States
  • Forest Investigative Site 133
    Phoenix, Arizona 85023, United States
  • Forest Investigative Site 044
    Scottsdale, Arizona 85254, United States
  • Forest Investigative Site 087
    Tucson, Arizona 85741, United States
  • Forest Investigative Site 061
    Anaheim, California 92801, United States
  • Forest Investigative Site 152
    Anaheim, California 92804, United States
  • Forest Investigative Site 041
    Chula Vista, California 91911, United States
  • Forest Investigative Site 049
    Encinitas, California 92024, United States
  • Forest Investigative Site 022
    Greenbrae, California 94904, United States
  • Forest Investigative Site 047
    Harbor City, California 90710, United States
  • Forest Investigative Site 010
    Huntington Park, California 90255, United States
  • Forest Investigative Site 070
    Los Angeles, California 90057, United States
  • Forest Investigative Site 111
    Northridge, California 91325, United States
  • Forest Investigative Site 031
    Riverside, California 92506, United States
  • Forest Investigative Site 091
    Roseville, California 95661, United States
  • Forest Investigative Site 140
    Sacramento, California 95816, United States
  • Forest Investigative Site 067
    Sacramento, California 95821, United States
  • Forest Investigative Site 145
    San Mateo, California 94401, United States
  • Forest Investigative Site 112
    Santa Ana, California 92701, United States
  • Forest Investigative Site 128
    Tustin, California 92780, United States
  • Forest Investigative Site 011
    Walnut Creek, California 94598, United States
  • Forest Investigative Site 063
    West Hills, California 91307, United States
  • Forest Investigative Site 115
    Colorado Springs, Colorado 80910, United States
  • Forest Investigative Site 088
    Denver, Colorado 80239, United States
  • Forest Investigative Site 156
    Boca Raton, Florida 33432, United States
  • Forest Investigative Site 148
    Brandenton, Florida 34205, United States
  • Forest Investigative Site 073
    Clearwater, Florida 33765, United States
  • Forest Investigative Site 004
    Daytona Beach, Florida 32117, United States
  • Forest Investigative Site 052
    DeLand, Florida 32720, United States
  • Forest Investigative Site 144
    Hialeah, Florida 33012, United States
  • Forest Investigative Site 129
    Hollywood, Florida 33021, United States
  • Forest Investigative Site 062
    Jacksonville, Florida 32205, United States
  • Forest Investigative Site 125
    Miami Lakes, Florida 33014, United States
  • Forest Investigative Site 161
    Miami, Florida 33136, United States
  • Forest Investigative Site 157
    Miami, Florida 33143, United States
  • Forest Investigative Site 154
    Miami, Florida 33175, United States
  • Forest Investigative Site 050
    Miami, Florida 33183, United States
  • Forest Investigative Site 122
    Miami, Florida 33186, United States
  • Forest Investigative Site 069
    New Port Richey, Florida 34652, United States
  • Forest Investigative Site 012
    Ocala, Florida 34471, United States
  • Forest Investigative Site 015
    Orlando, Florida 32806, United States
  • Forest Investigative Site 131
    Ormond Beach, Florida 32174, United States
  • Forest Investigative Site 127
    Pembroke Pines, Florida 33028, United States
  • Forest Investigative Site 018
    Sarasota, Florida 34239, United States
  • Forest Investigative Site 075
    St Petersburg, Florida 33716, United States
  • Forest Investigative Site 138
    Tamarac, Florida 33319, United States
  • Forest Investigative Site 026
    West Palm Beach, Florida 33401, United States
  • Forest Investigative Site 045
    Atlanta, Georgia 30338, United States
  • Forest Investigative Site 079
    Augusta, Georgia 30909, United States
  • Forest Investigative Site 077
    Decatur, Georgia 30035, United States
  • Forest Investigative Site 042
    Dunwoody, Georgia 30338, United States
  • Forest Investigative Site 084
    Roswell, Georgia 30076, United States
  • Forest Investigative Site 132
    Roswell, Georgia 30076, United States
  • Forest Investigative Site 009
    Meridian, Idaho 83646, United States
  • Forest Investigative Site 030
    Peoria, Illinois 61614, United States
  • Forest Investigative Site 123
    Springfield, Illinois 62704, United States
  • Forest Investigative Site 100
    Evansville, Indiana 47710, United States
  • Forest Investigative Site 097
    Evansville, Indiana 47713, United States
  • Forest Investigative Site 053
    Kansas City, Kansas 66160, United States
  • Forest Investigative Site 008
    Wichita, Kansas 67203, United States
  • Forest Investigative Site 078
    Erlanger, Kentucky 41018, United States
  • Forest Investigative Site 107
    Lexington, Kentucky 40504, United States
  • Forest Investigative Site 024
    Madisonville, Kentucky 42431, United States
  • Forest Investigative Site 034
    Covington, Louisiana 70433, United States
  • Forest Investigative Site 035
    Baltimore, Maryland 21204, United States
  • Forest Investigative Site 046
    Oxon Hill, Maryland 20745, United States
  • Forest Investigative Site 165
    Rockville, Maryland 20852, United States
  • Forest Investigative Site 003
    Brockton, Massachusetts 02301, United States
  • Forest Investigative Site 055
    Brockton, Massachusetts 02301, United States
  • Forest Investigative Site 118
    New Bedford, Massachusetts 02740, United States
  • Forest Investigative Site 007
    Waltham, Massachusetts 02453, United States
  • Forest Investigative Site 163
    Cadillac, Michigan 49601, United States
  • Forest Investigative Site 002
    Dearborn, Michigan 48126, United States
  • Forest Investigative Site 029
    St. Clair Shores, Michigan 48081, United States
  • Forest Investigative Site 054
    Edina, Minnesota 55435, United States
  • Forest Investigative Site 142
    St. Louis, Missouri 63110, United States
  • Forest Investigative Site 143
    St. Louis, Missouri 63110, United States
  • Forest Investigative Site 013
    Grand Island, Nebraska 68803, United States
  • Forest Investigative Site 150
    Omaha, Nebraska 68114, United States
  • Forest Investigative Site 072
    Las Vegas, Nevada 89101, United States
  • Forest Investigative Site 065
    Las Vegas, Nevada 89117, United States
  • Forest Investigative Site 147
    Berkeley Heights, New Jersey 07922, United States
  • Forest Investigative Site 137
    Albuquerque, New Mexico 87102, United States
  • Forest Investigative Site 101
    Albuquerque, New Mexico 87108, United States
  • Forest Investigative Site 006
    Albany, New York 12206, United States
  • Forest Investigative Site 081
    New Hyde Park, New York 11042, United States
  • Forest Investigative Site 016
    New York, New York 10019, United States
  • Forest Investigative Site 151
    New York, New York 10032, United States
  • Forest Investigative Site 155
    Asheboro, North Carolina 27203, United States
  • Forest Investigative Site 094
    Charlotte, North Carolina 28204, United States
  • Forest Investigative Site 051
    Charlotte, North Carolina 28209, United States
  • Forest Investigative Site 117
    Charlotte, North Carolina 28277, United States
  • Forest Investigative Site 135
    Durham, North Carolina 27704, United States

Showing the first 100 of 149 sites.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01089790
Lead sponsor
Forest Laboratories
Collaborators
Phenomix
Responsible party
Sponsor
First posted
Mar 19, 2010
Start date
Mar 2010
Primary completion
Aug 2010
Last update
Sep 21, 2011

Study contacts

Kaity Posada, PharmD
study director · Forest Research Institute, a subsidiary of Forest Laboratories Inc.

Oversight

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

Not currently enrolling

This study is terminated, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion