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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
dutogliptin
placebo
Sponsored by
Phenomix
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring diabetes, DPP4 inhibitor, dutogliptin

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

  • Type 1 diabetes mellitus

Sites / Locations

  • Phenomix Investigational Site 115
  • Phenomix Investigational Site 121
  • Phenomix Investigational Site 137
  • Phenomix Investigational Site 105
  • Phenomix Investigational Site 123
  • Phenomix Investigational Site 134
  • Phenomix Investigational Site 103
  • Phenomix Investigational Site 106
  • Phenomix Investigational Site 143
  • Phenomix Investigational Site 142
  • Phenomix Investigational Site 119
  • Phenomix Investigational Site 133
  • Phenomix Investigational Site 141
  • Phenomix Investigational Site 101
  • Phenomix Investigational Site 135
  • Phenomix Investigational Site 124
  • Phenomix Investigational Site 127
  • Phenomix Investigational Site 136
  • Phenomix Investigational Site 125
  • Phenomix Investigational Site 138
  • Phenomix Investigational Site 122
  • Phenomix Investigational Site 140
  • Phenomix Investigational Site 131
  • Phenomix Investigational Site 110
  • Phenomix Investigational Site 116
  • Phenomix Investigational Site 107
  • Phenomix Investigational Site 130
  • Phenomix Investigational Site 118
  • Phenomix Investigational Site 112
  • Phenomix Investigational Site 102
  • Phenomix Investigational Site 139
  • Phenomix Investigational Site 126
  • Phenomix Investigational Site 104
  • Phenomix Investigational Site 100
  • Phenomix Investigational Site 401
  • Phenomix Investigational Site 402
  • Phenomix Investigational Site 404
  • Phenomix Investigational Site 405
  • Phenomix Investigational Site 406
  • Phenomix Investigational Site 407
  • Phenomix Investigational Site 408
  • Phenomix Investigational Site 409
  • Phenomix Investigational Site 411
  • Phenomix Investigational Site 403
  • Phenomix Investigational Site 410
  • Phenomix Investigational Site 400
  • Phenomix Investigational Site 502
  • Phenomix Investigational Site 504
  • Phenomix Investigational Site 505
  • Phenomix Investigational Site 500
  • Phenomix Investigational Site 501
  • Phenomix Investigational Site 209
  • Phenomix Investigational Site 205
  • Phenomix Investigational Site 204
  • Phenomix Investigational Site 202
  • Phenomix Investigational Site 206
  • Phenomix Investigational Site 208
  • Phenomix Investigational Site 203
  • Phenomix Investigational Site 207
  • Phenomix Investigational Site 201
  • Phenomix Investigational Site 703
  • Phenomix Investigational Site 704
  • Phenomix Investigational Site 709
  • Phenomix Investigational Site 707
  • Phenomix Investigational Site 701
  • Phenomix Investigational Site 702
  • Phenomix Investigational Site 705
  • Phenomix Investigational Site 706
  • Phenomix Investigational Site 700
  • Phenomix Investigational Site 710
  • Phenomix Investigational Site 711
  • Phenomix Investigational Site 708
  • Phenomix Investigational Site 607
  • Phenomix Investigational Site 605
  • Phenomix Investigational Site 601
  • Phenomix Investigational Site 600
  • Phenomix Investigational Site 603
  • Phenomix Investigational Site 604
  • Phenomix Investigational Site 608
  • Phenomix Investigational Site 610
  • Phenomix Investigational Site 606
  • Phenomix Investigational Site 602
  • Phenomix Investigational Site 609
  • Phenomix Investigational Site 300
  • Phenomix Investigational Site 301
  • Phenomix Investigational Site 303
  • Phenomix Investigational Site 312
  • Phenomix Investigational Site 309
  • Phenomix Investigational Site 313
  • Phenomix Investigational Site 308
  • Phenomix Investigational Site 310
  • Phenomix Investigational Site 306
  • Phenomix Investigational Site 304
  • Phenomix Investigational Site 305
  • Phenomix Investigational Site 307
  • Phenomix Investigational Site 311
  • Phenomix Investigational Site 302

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

dutogliptin/PHX1149T

Plabeco

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Demonstrate safety and tolerability of dutogliptin
• Demonstrate changes in fasting plasma glucose

Full Information

First Posted
February 20, 2009
Last Updated
August 10, 2010
Sponsor
Phenomix
Collaborators
Forest Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT00850239
Brief Title
Safety and Efficacy Study of Dutogliptin/PHX1149T in Subjects With Type 2 Diabetes Mellitus on a Background Medication of Metformin
Official Title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate Safety and Efficacy of Dutogliptin/PHX1149T in Subjects With Type 2 Diabetes Mellitus on a Background Medication of Metformin
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Terminated
Study Start Date
May 2009 (undefined)
Primary Completion Date
October 2010 (Anticipated)
Study Completion Date
December 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Phenomix
Collaborators
Forest Laboratories

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
diabetes, DPP4 inhibitor, dutogliptin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
700 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
dutogliptin/PHX1149T
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Plabeco
Intervention Type
Drug
Intervention Name(s)
dutogliptin
Other Intervention Name(s)
PHX1149T
Intervention Description
400 mg
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Demonstrate safety and tolerability of dutogliptin
Time Frame
26 weeks
Title
• Demonstrate changes in fasting plasma glucose
Time Frame
26 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: Type 1 diabetes mellitus
Facility Information:
Facility Name
Phenomix Investigational Site 115
City
Montgomery
State/Province
Alabama
Country
United States
Facility Name
Phenomix Investigational Site 121
City
Tempe
State/Province
Arizona
Country
United States
Facility Name
Phenomix Investigational Site 137
City
Tempe
State/Province
Arizona
Country
United States
Facility Name
Phenomix Investigational Site 105
City
Anaheim
State/Province
California
Country
United States
Facility Name
Phenomix Investigational Site 123
City
Chico
State/Province
California
Country
United States
Facility Name
Phenomix Investigational Site 134
City
Escondido
State/Province
California
Country
United States
Facility Name
Phenomix Investigational Site 103
City
Long Beach
State/Province
California
Country
United States
Facility Name
Phenomix Investigational Site 106
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Phenomix Investigational Site 143
City
Coral Gables
State/Province
Florida
Country
United States
Facility Name
Phenomix Investigational Site 142
City
Hialeah
State/Province
Florida
Country
United States
Facility Name
Phenomix Investigational Site 119
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
Phenomix Investigational Site 133
City
Kissimmee
State/Province
Florida
Country
United States
Facility Name
Phenomix Investigational Site 141
City
Dunwoody
State/Province
Georgia
Country
United States
Facility Name
Phenomix Investigational Site 101
City
Honolulu
State/Province
Hawaii
Country
United States
Facility Name
Phenomix Investigational Site 135
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Phenomix Investigational Site 124
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
Phenomix Investigational Site 127
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
Phenomix Investigational Site 136
City
Brockton
State/Province
Massachusetts
Country
United States
Facility Name
Phenomix Investigational Site 125
City
Kalamazoo
State/Province
Michigan
Country
United States
Facility Name
Phenomix Investigational Site 138
City
Biloxi
State/Province
Mississippi
Country
United States
Facility Name
Phenomix Investigational Site 122
City
Las Vegas
State/Province
Nevada
Country
United States
Facility Name
Phenomix Investigational Site 140
City
Las Vegas
State/Province
Nevada
Country
United States
Facility Name
Phenomix Investigational Site 131
City
Brick
State/Province
New Jersey
Country
United States
Facility Name
Phenomix Investigational Site 110
City
Trenton
State/Province
New Jersey
Country
United States
Facility Name
Phenomix Investigational Site 116
City
Albuquerque
State/Province
New Mexico
Country
United States
Facility Name
Phenomix Investigational Site 107
City
Winston-Salem
State/Province
North Carolina
Country
United States
Facility Name
Phenomix Investigational Site 130
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Phenomix Investigational Site 118
City
Cuyahoga Falls
State/Province
Ohio
Country
United States
Facility Name
Phenomix Investigational Site 112
City
Greenville
State/Province
South Carolina
Country
United States
Facility Name
Phenomix Investigational Site 102
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Phenomix Investigational Site 139
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Phenomix Investigational Site 126
City
El Paso
State/Province
Texas
Country
United States
Facility Name
Phenomix Investigational Site 104
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Phenomix Investigational Site 100
City
Kenosha
State/Province
Wisconsin
Country
United States
Facility Name
Phenomix Investigational Site 401
City
Buenos Aires
Country
Argentina
Facility Name
Phenomix Investigational Site 402
City
Buenos Aires
Country
Argentina
Facility Name
Phenomix Investigational Site 404
City
Buenos Aires
Country
Argentina
Facility Name
Phenomix Investigational Site 405
City
Buenos Aires
Country
Argentina
Facility Name
Phenomix Investigational Site 406
City
Buenos Aires
Country
Argentina
Facility Name
Phenomix Investigational Site 407
City
Buenos Aires
Country
Argentina
Facility Name
Phenomix Investigational Site 408
City
Buenos Aires
Country
Argentina
Facility Name
Phenomix Investigational Site 409
City
Buenos Aires
Country
Argentina
Facility Name
Phenomix Investigational Site 411
City
Buenos Aires
Country
Argentina
Facility Name
Phenomix Investigational Site 403
City
Corrientes
Country
Argentina
Facility Name
Phenomix Investigational Site 410
City
Mendoza
Country
Argentina
Facility Name
Phenomix Investigational Site 400
City
Rosario
Country
Argentina
Facility Name
Phenomix Investigational Site 502
City
Santiago
Country
Chile
Facility Name
Phenomix Investigational Site 504
City
Santiago
Country
Chile
Facility Name
Phenomix Investigational Site 505
City
Santiago
Country
Chile
Facility Name
Phenomix Investigational Site 500
City
Temuco
Country
Chile
Facility Name
Phenomix Investigational Site 501
City
Temuco
Country
Chile
Facility Name
Phenomix Investigational Site 209
City
Chodov
Country
Czech Republic
Facility Name
Phenomix Investigational Site 205
City
Havířov-Město
Country
Czech Republic
Facility Name
Phenomix Investigational Site 204
City
Liberec
Country
Czech Republic
Facility Name
Phenomix Investigational Site 202
City
Olomouc
Country
Czech Republic
Facility Name
Phenomix Investigational Site 206
City
Ostrava Kunčice
Country
Czech Republic
Facility Name
Phenomix Investigational Site 208
City
Praha
Country
Czech Republic
Facility Name
Phenomix Investigational Site 203
City
Prostějov
Country
Czech Republic
Facility Name
Phenomix Investigational Site 207
City
Uničov
Country
Czech Republic
Facility Name
Phenomix Investigational Site 201
City
Valašské Klobouky
Country
Czech Republic
Facility Name
Phenomix Investigational Site 703
City
Hyderabad
State/Province
Andhara Pradesh
Country
India
Facility Name
Phenomix Investigational Site 704
City
Visakhapatanam
State/Province
Andhra Pradesh
Country
India
Facility Name
Phenomix Investigational Site 709
City
Gopalapuram
State/Province
Chennai
Country
India
Facility Name
Phenomix Investigational Site 707
City
Shastrinagar
State/Province
Jaipur
Country
India
Facility Name
Phenomix Investigational Site 701
City
Bangalore
State/Province
Karnataka
Country
India
Facility Name
Phenomix Investigational Site 702
City
Bangalore
State/Province
Karnataka
Country
India
Facility Name
Phenomix Investigational Site 705
City
Trivandrum
State/Province
Kerala
Country
India
Facility Name
Phenomix Investigational Site 706
City
Indore
State/Province
Madhya Pradesh
Country
India
Facility Name
Phenomix Investigational Site 700
City
Nashik
State/Province
Maharashtra
Country
India
Facility Name
Phenomix Investigational Site 710
City
Navi Mumbai
State/Province
Maharashtra
Country
India
Facility Name
Phenomix Investigational Site 711
City
Mumbai
State/Province
Maharastra
Country
India
Facility Name
Phenomix Investigational Site 708
City
Chennai
Country
India
Facility Name
Phenomix Investigational Site 607
City
Arequipa
Country
Peru
Facility Name
Phenomix Investigational Site 605
City
Cercado de Lima
Country
Peru
Facility Name
Phenomix Investigational Site 601
City
Ica
Country
Peru
Facility Name
Phenomix Investigational Site 600
City
Lima
Country
Peru
Facility Name
Phenomix Investigational Site 603
City
Lima
Country
Peru
Facility Name
Phenomix Investigational Site 604
City
Lima
Country
Peru
Facility Name
Phenomix Investigational Site 608
City
Lima
Country
Peru
Facility Name
Phenomix Investigational Site 610
City
Lima
Country
Peru
Facility Name
Phenomix Investigational Site 606
City
Piura
Country
Peru
Facility Name
Phenomix Investigational Site 602
City
Trujillo
Country
Peru
Facility Name
Phenomix Investigational Site 609
City
Wanchaq Cusco
Country
Peru
Facility Name
Phenomix Investigational Site 300
City
Gdańsk
Country
Poland
Facility Name
Phenomix Investigational Site 301
City
Gdańsk
Country
Poland
Facility Name
Phenomix Investigational Site 303
City
Katowice
Country
Poland
Facility Name
Phenomix Investigational Site 312
City
Katowice
Country
Poland
Facility Name
Phenomix Investigational Site 309
City
Kraków
Country
Poland
Facility Name
Phenomix Investigational Site 313
City
Kraków
Country
Poland
Facility Name
Phenomix Investigational Site 308
City
Lublin
Country
Poland
Facility Name
Phenomix Investigational Site 310
City
Poznan
Country
Poland
Facility Name
Phenomix Investigational Site 306
City
Puławy
Country
Poland
Facility Name
Phenomix Investigational Site 304
City
Szczecin
Country
Poland
Facility Name
Phenomix Investigational Site 305
City
Warszawa
Country
Poland
Facility Name
Phenomix Investigational Site 307
City
Warszawa
Country
Poland
Facility Name
Phenomix Investigational Site 311
City
Warszawa
Country
Poland
Facility Name
Phenomix Investigational Site 302
City
Wrocław
Country
Poland

12. IPD Sharing Statement

Learn more about this trial

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

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