Safety and Efficacy Study of Dutogliptin 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: sitagliptin; Drug: dutogliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00998686

PHX1149-PROT402

Details and patient eligibility

About

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

Enrollment: 650 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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650 participants in 2 patient groups

dutogliptin/PHX1149T

Experimental group

Treatment:

Drug: dutogliptin

sitagliptin

Active Comparator group

Treatment:

Drug: sitagliptin