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

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01101945

Enrollment

339

Registered

2010-04-12

Start date

2007-07-31

Completion date

2010-03-31

Last updated

2010-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Keywords

diabetes, DPP4 inhibitor, dutogliptin, PHX1149

Brief summary

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

Interventions

DRUGdutogliptin

400 mg QD

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
To demonstrate safety and tolerability of dutogliptin/PHX1149T as assessed by vital signs, adverse event reporting, and routine clinical laboratory assessments	104 weeks
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)

Secondary

Measure	Time frame
To demonstrate maintenance or lowering of HbA1c and fasting blood glucose	104 weeks

Countries

Argentina, Canada, India, Mexico, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026