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

Phase 2

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: PHX1149

• Registration Number: NCT00530881
• Lead Sponsor: Phenomix

Brief Summary

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"

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04
• Study Completion: 2006-10
• Status Verified: 2007-09
• Study First Submitted: 2007-09-14
• Study First Submitted QC: 2007-09-17
• Last Update Submitted: 2007-09-17
• Study First Posted: 2007-09-18
• Last Update Posted: 2007-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

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

Exclusion Criteria

• Type 1 diabetes mellitus

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4	PHX1149	-
3 active, 1 placebo	PHX1149	-

Primary Outcome Measures

Name	Time	Method
postprandial blood glucose

Secondary Outcome Measures

Name	Time	Method
fasting blood glucose, HbA1c, safety

Trial Locations

Locations (1)

Multiple Sites; 🇺🇸 san Diego, California, United States