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Long-term Study to Evaluate the Safety of Dutogliptin/PHX1149T in Subjects With Type 2 Diabetes Mellitus

Primary Purpose

Type 2 Diabetes Mellitus, Type 2 Diabetes

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

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring diabetes, DPP4 inhibitor, dutogliptin, PHX1149

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 (e.g., Visit 8/Day 196 of PHX1149-PROT301)
  • Current treatment of Type 2 diabetes mellitus as in PHX1149-PROT301

Exclusion Criteria:

  • Except for Type 2 diabetes, any other uncontrolled, serious pulmonary, cardiovascular, hematologic, renal, gastrointestinal, endocrine, neurological, proliferative, immunosuppressive, psychiatric, or urogenital disorder; or diseases of skin and its appendages, the eyes, ears, nose, or throat
  • 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 663
  • Phenomix Investigational Site 103
  • Phenomix Investigational Site 110
  • Phenomix Investigational Site 111
  • Phenomix Investigational Site 106
  • Phenomix Investigational Site 112
  • Phenomix Investigational Site 102
  • Phenomix Investigational Site 403
  • Phenomix Investigational Site 404
  • Phenomix Investigational Site 604
  • Phenomix Investigational Site 606
  • Phenomix Investigational Site 600
  • Phenomix Investigational Site 601
  • Phenomix Investigational Site 602
  • Phenomix Investigational Site 609
  • Phenomix Investigational Site 703
  • Phenomix Investigational Site 802
  • Phenomix Investigational Site 806
  • Phenomix Investigational Site 800
  • Phenomix Investigational Site 803
  • Phenomix Investigational Site 805
  • Phenomix Investigational Site 807
  • Phenomix Investigational Site 804
  • Phenomix Investigational Site 801
  • Phenomix Investigational Site 808
  • Phenomix Investigational Site 551
  • Phenomix Investigational Site 557
  • Phenomix Investigational Site 564
  • Phenomix Investigational Site 550
  • Phenomix Investigational Site 555
  • Phenomix Investigational Site 556
  • Phenomix Investigational Site 562
  • Phenomix Investigational Site 563
  • Phenomix Investigational Site 554
  • Phenomix Investigational Site 565
  • Phenomix Investigational Site 553
  • Phenomix Investigational Site 561
  • Phenomix Investigational Site 560
  • Phenomix Investigational Site 559
  • Phenomix Investigational Site 552

Outcomes

Primary Outcome Measures

To demonstrate safety and tolerability of dutogliptin

Secondary Outcome Measures

To demonstrate maintenance or lowering of HbA1c
To demonstrate maintenance or lowering of fasting blood glucose

Full Information

First Posted
March 17, 2009
Last Updated
August 10, 2010
Sponsor
Phenomix
Collaborators
Forest Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT00865592
Brief Title
Long-term Study to Evaluate the Safety of Dutogliptin/PHX1149T in Subjects With Type 2 Diabetes Mellitus
Official Title
An Open Label, Multi-Center, Long-Term Extension Study to Evaluate the Safety of PHX1149T/Dutogliptin in Subjects With Type 2 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Terminated
Study Start Date
March 2009 (undefined)
Primary Completion Date
January 2011 (Anticipated)
Study Completion Date
March 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 that dutogliptin/PHX1149T is safe and tolerable.
Detailed Description
In this study, open-label dutogliptin/PHX1149T will be offered to subjects who complete a Phase 3 core protocol and wish to continue treatment with dutogliptin. This will allow for the collection of long-term safety data and will also demonstrate long-term effects on HbA1c and fasting blood glucose.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Type 2 Diabetes
Keywords
diabetes, DPP4 inhibitor, dutogliptin, PHX1149

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
450 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
dutogliptin
Other Intervention Name(s)
PHX1149T, PHX1149, dutogliptin tartrate
Intervention Description
dutogliptin 400 mg, once daily tablet
Primary Outcome Measure Information:
Title
To demonstrate safety and tolerability of dutogliptin
Time Frame
Two years
Secondary Outcome Measure Information:
Title
To demonstrate maintenance or lowering of HbA1c
Time Frame
Two years
Title
To demonstrate maintenance or lowering of fasting blood glucose
Time Frame
Two years

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 (e.g., Visit 8/Day 196 of PHX1149-PROT301) Current treatment of Type 2 diabetes mellitus as in PHX1149-PROT301 Exclusion Criteria: Except for Type 2 diabetes, any other uncontrolled, serious pulmonary, cardiovascular, hematologic, renal, gastrointestinal, endocrine, neurological, proliferative, immunosuppressive, psychiatric, or urogenital disorder; or diseases of skin and its appendages, the eyes, ears, nose, or throat 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:
City
Norwalk
State/Province
California
Country
United States
City
Orange
State/Province
California
Country
United States
City
Santa Ana
State/Province
California
Country
United States
City
Daytona Beach
State/Province
Florida
Country
United States
City
Kissimmee
State/Province
Florida
Country
United States
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Phenomix Investigational Site 663
City
Honolulu
State/Province
Hawaii
Country
United States
City
Brockton
State/Province
Massachusetts
Country
United States
City
St. Louis
State/Province
Missouri
Country
United States
City
Cincinnati
State/Province
Ohio
Country
United States
City
El Paso
State/Province
Texas
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
Norfolk
State/Province
Virginia
Country
United States
Facility Name
Phenomix Investigational Site 103
City
Buenos Aires
Country
Argentina
Facility Name
Phenomix Investigational Site 110
City
Buenos Aires
Country
Argentina
Facility Name
Phenomix Investigational Site 111
City
Buenos Aires
Country
Argentina
Facility Name
Phenomix Investigational Site 106
City
Caba
Country
Argentina
Facility Name
Phenomix Investigational Site 112
City
Corrientes
Country
Argentina
Facility Name
Phenomix Investigational Site 102
City
Paraná
Country
Argentina
City
Bangalore, Karnataka
Country
India
City
Chennai, Tamil Nadu
Country
India
City
Gulbarga, Karnataka
Country
India
City
Hyderabad, Andhara Pradesh
Country
India
City
Mumbai, Maharashtra
Country
India
City
Nagpur, Maharashtra
Country
India
City
Nashik, Maharashtra
Country
India
City
Navi Mumbai, Maharashtra
Country
India
City
Pune, Maharashtra
Country
India
Facility Name
Phenomix Investigational Site 403
City
Kuching
State/Province
Sarawak
Country
Malaysia
City
Kelantan
Country
Malaysia
City
Kuala Lumpur
Country
Malaysia
City
Perak
Country
Malaysia
Facility Name
Phenomix Investigational Site 404
City
Putrajaya
Country
Malaysia
City
Sarawak
Country
Malaysia
Facility Name
Phenomix Investigational Site 604
City
Arequipa
Country
Peru
Facility Name
Phenomix Investigational Site 606
City
Lambayeque
Country
Peru
Facility Name
Phenomix Investigational Site 600
City
Lima
Country
Peru
Facility Name
Phenomix Investigational Site 601
City
Lima
Country
Peru
Facility Name
Phenomix Investigational Site 602
City
Lima
Country
Peru
Facility Name
Phenomix Investigational Site 609
City
Lima
Country
Peru
Facility Name
Phenomix Investigational Site 703
City
Cebu City
Country
Philippines
City
Manila, NCR
Country
Philippines
City
Quezon City, NCR
Country
Philippines
City
San Juan, NCR
Country
Philippines
Facility Name
Phenomix Investigational Site 802
City
Brasov
Country
Romania
Facility Name
Phenomix Investigational Site 806
City
Brasov
Country
Romania
Facility Name
Phenomix Investigational Site 800
City
Bucharest
Country
Romania
Facility Name
Phenomix Investigational Site 803
City
Bucharest
Country
Romania
Facility Name
Phenomix Investigational Site 805
City
Bucharest
Country
Romania
Facility Name
Phenomix Investigational Site 807
City
Bucharest
Country
Romania
Facility Name
Phenomix Investigational Site 804
City
Galati
Country
Romania
Facility Name
Phenomix Investigational Site 801
City
Ploieşti
Country
Romania
Facility Name
Phenomix Investigational Site 808
City
Sibiu
Country
Romania
Facility Name
Phenomix Investigational Site 551
City
Ivano-Frankivsk
Country
Ukraine
Facility Name
Phenomix Investigational Site 557
City
Kharkiv
Country
Ukraine
Facility Name
Phenomix Investigational Site 564
City
Kharkiv
Country
Ukraine
Facility Name
Phenomix Investigational Site 550
City
Kharkov
Country
Ukraine
Facility Name
Phenomix Investigational Site 555
City
Kiev
Country
Ukraine
Facility Name
Phenomix Investigational Site 556
City
Kiev
Country
Ukraine
Facility Name
Phenomix Investigational Site 562
City
Kiev
Country
Ukraine
Facility Name
Phenomix Investigational Site 563
City
Kiev
Country
Ukraine
Facility Name
Phenomix Investigational Site 554
City
Kylv
Country
Ukraine
Facility Name
Phenomix Investigational Site 565
City
Lutsk
Country
Ukraine
Facility Name
Phenomix Investigational Site 553
City
Lviv
Country
Ukraine
Facility Name
Phenomix Investigational Site 561
City
Poltava
Country
Ukraine
Facility Name
Phenomix Investigational Site 560
City
Simferopol
Country
Ukraine
Facility Name
Phenomix Investigational Site 559
City
Vinnitsa
Country
Ukraine
Facility Name
Phenomix Investigational Site 552
City
Zaporzhzhia
Country
Ukraine

12. IPD Sharing Statement

Learn more about this trial

Long-term Study to Evaluate the Safety of Dutogliptin/PHX1149T in Subjects With Type 2 Diabetes Mellitus

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