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

Phenomix

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Placebo; Drug: PHX1149T

Study type: Interventional

Funder types: Industry

Identifiers

NCT00690638

PHX1149-PROT301

EudraCT 2008-002614-22

Details and patient eligibility

About

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

Enrollment: 480 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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480 participants in 3 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

2

Experimental group

Description:

PHX1149T 200 mg

Treatment:

Drug: PHX1149T

Drug: PHX1149T

3

Experimental group

Description:

PHX1149T 400 mg

Treatment:

Drug: PHX1149T

Drug: PHX1149T