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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01101945
• Other study ID #: PHX1149-PROT202E
• Status: Terminated
• Phase: Phase 2
• First received: April 8, 2010
• Last updated: August 10, 2010
• Start date: July 2007
• Est. completion date: March 2010

Study information

• Verified date: August 2010
• Source: Phenomix
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaIndia: Ministry of HealthMexico: Secretaria de SaludArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 339
• Est. completion date: March 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• dutogliptin
400 mg QD

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Phenomix

Countries where clinical trial is conducted

United States,  Argentina,  Canada,  India,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To demonstrate safety and tolerability of dutogliptin/PHX1149T as assessed by vital signs, adverse event reporting, and routine clinical laboratory assessments		104 weeks	Yes
Primary	To demonstrate safety and tolerability of dutogliptin/PHX1149Tas assessed by vital signs, adverse event reporting, and routine clinical laboratory assessments		208 weeks (U.S. only)	Yes
Secondary	To demonstrate maintenance or lowering of HbA1c and fasting blood glucose		104 weeks	No