Randomized, Double-Blind, Placebo-Controlled, With PHX114... | NCT00530881

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

NCT00530881

Sponsor

Phenomix

Status

Completed

Last Update Posted

Sep 18, 2007Estimated

Enrollment

180Actual

Phase

Phase 2

Conditions

Type 2 Diabetes Mellitus

Interventions

PHX1149

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2006

Primary Completion Date

Not provided

Completion Date

Oct 2006Actual

First Submitted Date

Sep 14, 2007

First Submission Date that Met QC Criteria

Sep 17, 2007

First Posted Date

Sep 18, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 17, 2007

Last Update Posted Date

Sep 18, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

180Actual

Label	Type	Description	Intervention Names
4	Placebo Comparator		Drug: PHX1149
3 active, 1 placebo	Placebo Comparator		Drug: PHX1149

Name	Type	Description	Arm Group Labels	Other Names
PHX1149	Drug		3 active, 1 placebo 4

Measure	Description	Time Frame
postprandial blood glucose

Measure	Description	Time Frame
fasting blood glucose, HbA1c, safety

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Type 2 diabetes mellitus treatment with metformin +/- TZD

Exclusion Criteria:

Type 1 diabetes mellitus

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hans-Peter Guler, MD	Phenomix Corp.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Multiple Sites		San Diego	California	92121	United States

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided