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

A Phase 3, Randomized, Double-Blind, Active-Controlled, Multi-Center Extension Study to Evaluate Safety and Efficacy of Dutogliptin in Subjects With Type 2 Diabetes Mellitus on a Background Medication of Metformin

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00998686

Enrollment

650

Registered

2009-10-20

Start date

2009-11-30

Completion date

2011-11-30

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

Brief summary

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

Interventions

DRUGdutogliptin

400 mg

DRUGsitagliptin

100 mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
To demonstrate safety and tolerability of dutogliptin as assessed by vital signs, adverse event reporting, routine clinical laboratory assessments, and ECG	52 weeks

Secondary

Measure	Time frame
To demonstrate maintenance or lowering of HbA1c and fasting plasma glucose	52 weeks

Countries

Argentina, Czechia, India, Peru, Poland, United States

Outcome results

None listed

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