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Safety and Efficacy Study of Dutogliptin 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
sitagliptin
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:

  • Completion of all required visits of a qualifying Phase 3 core protocol
  • Current treatment of Type 2 diabetes mellitus as in PHX1149-PROT302

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

Sites / Locations

  • Phenomix Investigational Site 105
  • Phenomix Investigational Site 121
  • Phenomix Investigational Site 137
  • Phenomix Investigational Site 105
  • Phenomix Investigational Site 103
  • Phenomix Investigational Site 106
  • Phenomix Investigational Site 143
  • Phenomix Investigational Site 142
  • Phenomix Investigational Site 133
  • Phenomix Investigational Site 101
  • Phenomix Investigational Site 135
  • Phenomix Investigational Site 124
  • Phenomix Investigational Site 136
  • Phenomix Investigational Site 138
  • Phenomix Investigational Site 122
  • Phenomix Investigational Site 140
  • Phenomix Investigational Site 110
  • Phenomix Investigational Site 116
  • Phenomix Investigational Site 107
  • Phenomix Investigational Site 112
  • Phenomix Investigational Site 102
  • Phenomix Investigational Site 104
  • Phenomix Investigational Site 100
  • Phenomix Investigational Site 402
  • Phenomix Investigational Site 408
  • Phenomix Investigational Site 410
  • Phenomix Investigational Site 208
  • Phenomix Investigational Site 209
  • Phenomix Investigational Site 207
  • Phenomix Investigational Site 707
  • Phenomix Investigational Site 701
  • Phenomix Investigational Site 705
  • Phenomix Investigational Site 706
  • Phenomix Investigational Site 711
  • Phenomix Investigational Site 607
  • Phenomix Investigational Site 601
  • Phenomix Investigational Site 604
  • Phenomix Investigational Site 610
  • Phenomix Investigational Site 300
  • Phenomix Investigational Site 309
  • Phenomix Investigational Site 303
  • Phenomix Investigational Site 306
  • Phenomix Investigational Site 305
  • Phenomix Investigational Site 302

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

dutogliptin/PHX1149T

sitagliptin

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

To demonstrate maintenance or lowering of HbA1c and fasting plasma glucose

Full Information

First Posted
October 16, 2009
Last Updated
August 10, 2010
Sponsor
Phenomix
Collaborators
Forest Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT00998686
Brief Title
Safety and Efficacy Study of Dutogliptin in Subjects With Type 2 Diabetes Mellitus on a Background Medication of Metformin
Official Title
A Phase 3, Randomized, Double-Blind, Active-Controlled, Multi-Center Extension Study to Evaluate Safety and Efficacy of Dutogliptin 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
November 2009 (undefined)
Primary Completion Date
October 2011 (Anticipated)
Study Completion Date
November 2011 (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 safety and tolerability of dutogliptin over 52 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
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
650 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
dutogliptin/PHX1149T
Arm Type
Experimental
Arm Title
sitagliptin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
dutogliptin
Intervention Description
400 mg
Intervention Type
Drug
Intervention Name(s)
sitagliptin
Intervention Description
100 mg
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
To demonstrate maintenance or lowering of HbA1c and fasting plasma glucose
Time Frame
52 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: Completion of all required visits of a qualifying Phase 3 core protocol Current treatment of Type 2 diabetes mellitus as in PHX1149-PROT302 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
Facility Information:
Facility Name
Phenomix Investigational Site 105
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 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 133
City
Kissimmee
State/Province
Florida
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 136
City
Brockton
State/Province
Massachusetts
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 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 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 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 402
City
Buenos Aires
Country
Argentina
Facility Name
Phenomix Investigational Site 408
City
Buenos Aires
Country
Argentina
Facility Name
Phenomix Investigational Site 410
City
Mendoza
Country
Argentina
Facility Name
Phenomix Investigational Site 208
City
Praha 10
Country
Czech Republic
Facility Name
Phenomix Investigational Site 209
City
Praha 4 Chodov
Country
Czech Republic
Facility Name
Phenomix Investigational Site 207
City
Unicov
Country
Czech Republic
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 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 711
City
Mumbai
State/Province
Maharashtra
Country
India
Facility Name
Phenomix Investigational Site 607
City
Arequipa
Country
Peru
Facility Name
Phenomix Investigational Site 601
City
Ica
Country
Peru
Facility Name
Phenomix Investigational Site 604
City
Lima
Country
Peru
Facility Name
Phenomix Investigational Site 610
City
Lima
Country
Peru
Facility Name
Phenomix Investigational Site 300
City
Gdansk
Country
Poland
Facility Name
Phenomix Investigational Site 309
City
Karkow
Country
Poland
Facility Name
Phenomix Investigational Site 303
City
Katowice
Country
Poland
Facility Name
Phenomix Investigational Site 306
City
Pulawy
Country
Poland
Facility Name
Phenomix Investigational Site 305
City
Warszawa
Country
Poland
Facility Name
Phenomix Investigational Site 302
City
Wroclaw
Country
Poland

12. IPD Sharing Statement

Learn more about this trial

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

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