Safety and Efficacy Study of Dutogliptin in Subjects With Type 2 Diabetes Mellitus on a Background Medication of Metformin

Phase 3TerminatedNCT00998686

Phenomix650 enrolled

Overview

The purpose of this study is to demonstrate the safety and tolerability of dutogliptin over 52 weeks.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

650

Conditions

Type 2 Diabetes Mellitus

Interventions

dutogliptinDRUG

400 mg

sitagliptinDRUG

100 mg

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Completion of all required visits of a qualifying Phase 3 core protocol * Current treatment of Type 2 diabetes mellitus as in PHX1149-PROT302 Exclusion Criteria: * Any condition, disease, disorder or clinically relevant laboratory abnormality which, in the opinion of the investigator, would jeopardize the patient's appropriate participation in this study or obscure the effects of treatment

Locations (44)

Outcomes

Primary Outcomes

To demonstrate safety and tolerability of dutogliptin as assessed by vital signs, adverse event reporting, routine clinical laboratory assessments, and ECG

Time frame: 52 weeks

Secondary Outcomes

To demonstrate maintenance or lowering of HbA1c and fasting plasma glucose

Time frame: 52 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Phenomix Investigational Site 105

Montgomery, Alabama, United States

Phenomix Investigational Site 121

Tempe, Arizona, United States

Phenomix Investigational Site 137

Tempe, Arizona, United States

Phenomix Investigational Site 105

Anaheim, California, United States

Phenomix Investigational Site 103

Long Beach, California, United States

Phenomix Investigational Site 106

Los Angeles, California, United States

Phenomix Investigational Site 143

Coral Gables, Florida, United States

Phenomix Investigational Site 142

Hialeah, Florida, United States

Phenomix Investigational Site 133

Kissimmee, Florida, United States

Phenomix Investigational Site 101

Honolulu, Hawaii, United States

...and 34 more locations