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

This study has been terminated.
Sponsor:
Information provided by:
Phenomix
ClinicalTrials.gov Identifier:
NCT01101945
First received: April 8, 2010
Last updated: August 10, 2010
Last verified: August 2010
History of Changes
  Purpose

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


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

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 Follow-up Study to Evaluate the Safety of PHX1149T in Subjects With Type 2 Diabetes Mellitus - Extension to Protocol PHX1149-PROT202

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Phenomix:

Primary Outcome Measures:
  • To demonstrate safety and tolerability of dutogliptin/PHX1149T as assessed by vital signs, adverse event reporting, and routine clinical laboratory assessments [ Time Frame: 104 weeks ] [ Designated as safety issue: Yes ]
  • To demonstrate safety and tolerability of dutogliptin/PHX1149Tas assessed by vital signs, adverse event reporting, and routine clinical laboratory assessments [ Time Frame: 208 weeks (U.S. only) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To demonstrate maintenance or lowering of HbA1c and fasting blood glucose [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]

Enrollment: 339
Study Start Date: July 2007
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: dutogliptin
    400 mg QD
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Completed Visit 7/Day 98 of the core protocol PHX1149-PROT202
  • Current treatment of Type 2 diabetes mellitus in accordance with product labeling with metformin, or thiazolidinedione (TZD), or metformin + TZD

Exclusion Criteria:

  • Inadequately controlled Type 2 diabetes mellitus with need for therapy with insulin
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01101945

  Show 55 Study Locations
Sponsors and Collaborators
Phenomix
  More Information

No publications provided

Responsible Party: Hans-Peter Guler, MD, Phenomix Corporation
ClinicalTrials.gov Identifier: NCT01101945     History of Changes
Other Study ID Numbers: PHX1149-PROT202E
Study First Received: April 8, 2010
Last Updated: August 10, 2010
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
India: Ministry of Health
Mexico: Secretaria de Salud
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

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 May 16, 2013