Safety and Efficacy Study of Dutogliptin/PHX1149T to Treat Type 2 Diabetes Mellitus

Phenomix480 enrolled

Overview

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate Safety and Efficacy of PHX1149T as Monotherapy in Subjects with Type 2 Diabetes Mellitus

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

480

Conditions

Type 2 Diabetes Mellitus

Interventions

PHX1149TDRUG

200 mg

PHX1149TDRUG

400 mg

PlaceboDRUG

Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Type 2 diabetes mellitus, drug naïve or willing to wash-out from existing oral therapy * BMI 25 to 48 kg/m2, inclusive * HbA1c 7.0% - 10.0%, inclusive * Age 18 to 75 years, inclusive Exclusion Criteria: * Currently on 3 or more oral antidiabetic drugs or insulin. * Type 1 diabetes mellitus

Locations (62)

Outcomes

Primary Outcomes

To demonstrate changes in HbA1c

Time frame: Day 28 to Day 196

Data from ClinicalTrials.gov

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Unnamed facility

Norwalk, California, United States

Unnamed facility

Orange, California, United States

Unnamed facility

Santa Ana, California, United States

Unnamed facility

Daytona Beach, Florida, United States

Unnamed facility

Kissimmee, Florida, United States

Unnamed facility

Atlanta, Georgia, United States

Unnamed facility

Honolulu, Hawaii, United States

Unnamed facility

Brockton, Massachusetts, United States

Unnamed facility

St Louis, Missouri, United States

Unnamed facility

Cincinnati, Ohio, United States

...and 52 more locations