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

Phase 2TerminatedNCT01101945

Phenomix339 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

339

Conditions

Type 2 Diabetes Mellitus

Interventions

dutogliptinDRUG

400 mg QD

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (55)

Outcomes

Primary Outcomes

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

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)

Secondary Outcomes

To demonstrate maintenance or lowering of HbA1c and fasting blood glucose

Time frame: 104 weeks

Data from ClinicalTrials.gov

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Unnamed facility

Fullerton, California, United States

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Long Beach, California, United States

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Orange, California, United States

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San Diego, California, United States

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Kissimmee, Florida, United States

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Melbourne, Florida, United States

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New Port Richey, Florida, United States

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Gurnee, Illinois, United States

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Wichita, Kansas, United States

Unnamed facility

Kansas City, Missouri, United States

...and 45 more locations