NCT00530881

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"

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for phase_2 type-2-diabetes-mellitus

Timeline
Completed

Started Apr 2006

Shorter than P25 for phase_2 type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 18, 2007

Completed
Last Updated

September 18, 2007

Status Verified

September 1, 2007

First QC Date

September 14, 2007

Last Update Submit

September 17, 2007

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • postprandial blood glucose

Secondary Outcomes (1)

  • fasting blood glucose, HbA1c, safety

Study Arms (2)

4

PLACEBO COMPARATOR
Drug: PHX1149

3 active, 1 placebo

PLACEBO COMPARATOR
Drug: PHX1149

Interventions

PHX1149DRUG
3 active, 1 placebo4

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Type 1 diabetes mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Multiple Sites

San Diego, California, 92121, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Hans-Peter Guler, MD

    Phenomix Corp.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 14, 2007

First Posted

September 18, 2007

Study Start

April 1, 2006

Study Completion

October 1, 2006

Last Updated

September 18, 2007

Record last verified: 2007-09

Locations

US(1)