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

NCT ID: NCT00530881

Last Updated: 2007-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2006-10-31

Brief Summary

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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

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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4

Group Type PLACEBO_COMPARATOR

PHX1149

Intervention Type DRUG

3 active, 1 placebo

Group Type PLACEBO_COMPARATOR

PHX1149

Intervention Type DRUG

Interventions

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PHX1149

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Type 1 diabetes mellitus
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Phenomix

INDUSTRY

Sponsor Role lead

Principal Investigators

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Hans-Peter Guler, MD

Role: STUDY_DIRECTOR

Phenomix Corp.

Locations

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Multiple Sites

San Diego, California, United States

Site Status

Countries

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United States

Other Identifiers

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PHX1149-Prot201

Identifier Type: -

Identifier Source: org_study_id