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
  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:


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
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: 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 August 28, 2014