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

Phenomix

Status and phase: Terminated; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: dutogliptin; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00850239

PHX1149-PROT302

Details and patient eligibility

About

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.

Enrollment: 700 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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700 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

dutogliptin/PHX1149T

Treatment:

Drug: dutogliptin

2

Placebo Comparator group

Description:

Plabeco

Treatment:

Drug: placebo