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

Phenomix

Status and phase: Terminated; Phase 2

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: dutogliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01101945

PHX1149-PROT202E

Details and patient eligibility

About

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

Enrollment: 339 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)