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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00690638

Enrollment

480

Registered

2008-06-04

Start date

2008-07-31

Completion date

2010-04-30

Last updated

2010-04-13

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

dutogliptin, PHX1149, DPP4 inhibitor

Brief summary

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

Interventions

DRUGPHX1149T

200 mg

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
To demonstrate changes in HbA1c	Day 28 to Day 196

Countries

Argentina, India, Malaysia, Peru, Philippines, Romania, Thailand, Ukraine, United States

Outcome results

None listed

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