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

This study has been terminated.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by:
Phenomix
ClinicalTrials.gov Identifier:
NCT00865592
First received: March 17, 2009
Last updated: August 10, 2010
Last verified: August 2010
  Purpose

The purpose of this study is to demonstrate that dutogliptin/PHX1149T is safe and tolerable.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Type 2 Diabetes
Drug: dutogliptin
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Phenomix:

Primary Outcome Measures:
  • To demonstrate safety and tolerability of dutogliptin [ Time Frame: Two years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To demonstrate maintenance or lowering of HbA1c [ Time Frame: Two years ] [ Designated as safety issue: Yes ]
  • To demonstrate maintenance or lowering of fasting blood glucose [ Time Frame: Two years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 450
Study Start Date: March 2009
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: dutogliptin
    dutogliptin 400 mg, once daily tablet
    Other Names:
    • PHX1149T
    • PHX1149
    • dutogliptin tartrate
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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00865592

  Show 68 Study Locations
Sponsors and Collaborators
Phenomix
Forest Laboratories
  More Information

No publications provided

Responsible Party: Hans-Peter Guler, MD, Phenomix
ClinicalTrials.gov Identifier: NCT00865592     History of Changes
Other Study ID Numbers: PHX1149-PROT300E
Study First Received: March 17, 2009
Last Updated: August 10, 2010
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
India: Drugs Controller General of India
Malaysia: Ministry of Health
Peru: Ethics Committee
Peru: General Directorate of Pharmaceuticals, Devices, and Drugs
Philippines: Bureau of Food and Drugs
Romania: National Medicines Agency
Thailand: Ethical Committee
Thailand: Khon Kaen University Ethics Committee for Human Research
Ukraine: State Pharmacological Center - Ministry of Health

Keywords provided by Phenomix:
diabetes
DPP4 inhibitor
dutogliptin
PHX1149

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on October 19, 2014