Safety and Efficacy Study of Dutogliptin/PHX1149T in Subjects With Type 2 Diabetes Mellitus on a Background Medication of Metformin

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate Safety and Efficacy of Dutogliptin/PHX1149T 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

NCT00850239

Enrollment

700

Registered

2009-02-24

Start date

2009-05-31

Completion date

2010-12-31

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

Brief summary

The purpose of this study is to demonstrate the efficacy of dutogliptin over 26 weeks (as evidenced by placebo-corrected changes in HbA1c relative to baseline), to demonstrate safety and tolerability of dutogliptin, and to demonstrate changes in fasting plasma glucose over 26 weeks.

Interventions

DRUGdutogliptin

400 mg

DRUGplacebo

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Inclusion criteria

* Type 2 diabetes mellitus, diagnosed at least 4 months prior to Screening (Visit 1) * Age 18 to 85 years, inclusive. * Male and non-pregnant, non-lactating (and not planning to become pregnant during the study) female subjects with a BMI of 20 to 48 kg/m2, inclusive * Current treatment of Type 2 diabetes mellitus with a stable dose of metformin of ≥ 2000 mg (or the highest tolerated dose) used in accordance with product labeling for at least 6 weeks prior to screening (Visit 1) * HbA1c 7.0% - 10.0%, inclusive; and fasting plasma C peptide greater than 0.26 nmol/L (\> 0.8 ng/mL; \> 281 pmol/L) at screening (Visit 1)

Exclusion criteria

* Type 1 diabetes mellitus

Design outcomes

Primary

Measure	Time frame
Primary objective is to demonstrate the efficacy of dutogliptin, as evidenced by placebo-corrected changes in HbA1c relative to baseline.	26 weeks

Secondary

Measure	Time frame
Demonstrate safety and tolerability of dutogliptin	26 weeks
• Demonstrate changes in fasting plasma glucose	26 weeks

Countries

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

Outcome results

None listed

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