Randomized, Double-Blind, Placebo-Controlled, With PHX1149 in Patients With Type 2 Diabetes Mellitus

Phenomix

Status and phase: Completed; Phase 2

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: PHX1149

Study type: Interventional

Funder types: Industry

Identifiers

NCT00530881

PHX1149-Prot201

Details and patient eligibility

About

This will be a 4-week, multicenter, randomized, double-blind, parallel group, placebo-controlled, safety, tolerability, and efficacy study. Patients will be screened and be on one of three doses of PHX1149 (a new drug candidate for the treatment of Type 2 diabetes ) or placebo. The drug is a "DPP4 inhibitor"

Enrollment: 180 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes mellitus treatment with metformin +/- TZD

Exclusion criteria

• Type 1 diabetes mellitus

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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180 participants in 2 patient groups, including a placebo group

4

Placebo Comparator group

Treatment:

Drug: PHX1149

3 active, 1 placebo

Placebo Comparator group

Treatment:

Drug: PHX1149