Safety and Efficacy Study of Dutogliptin/PHX1149T to Trea... | NCT00690638 | Trialant

Home
Search
Collections
Views
Audits

Terms of Service
Privacy Policy

Safety and Efficacy Study of Dutogliptin/PHX1149T to Trea... | NCT00690638 | Trialant

Studies
Safety and Efficacy Study of Dutogliptin/PHX1149T to Treat Type 2 Diabetes Mellitus

NCT00690638

Sponsor

Phenomix

Status

Completed

Last Update Posted

Apr 13, 2010Estimated

Enrollment

480Estimated

Phase

Phase 3

Conditions

Type 2 Diabetes Mellitus

Interventions

PHX1149T
PHX1149T
Placebo

Countries

United States
Argentina
India
Malaysia
Peru
Philippines
Romania
Thailand
Ukraine

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

NCT00690638

Obsolete or Duplicate NCT IDs

Not provided

Organization Study

PHX1149-PROT301

Secondary IDs

ID	Type	Description	Link
EudraCT 2008-002614-22

Brief Title

Safety and Efficacy Study of Dutogliptin/PHX1149T to Treat Type 2 Diabetes Mellitus

Official Title

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate Safety and Efficacy of PHX1149T as Monotherapy in Subjects With Type 2 Diabetes Mellitus

Acronym

Not provided

Organization

PhenomixINDUSTRY

Status Module

Record Verification Date

Jan 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

No

Start Date

Jul 2008

Primary Completion Date

Jan 2010Actual

Completion Date

Apr 2010Actual

First Submitted Date

Jun 2, 2008

First Submission Date that Met QC Criteria

Jun 3, 2008

First Posted Date

Jun 4, 2008Estimated

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

Apr 12, 2010

Last Update Posted Date

Apr 13, 2010Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

PhenomixINDUSTRY

Collaborators

Name	Class
Forest Laboratories	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

No

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

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate Safety and Efficacy of PHX1149T as Monotherapy in Subjects with Type 2 Diabetes Mellitus

Detailed Description

Not provided

Conditions Module

Conditions

Type 2 Diabetes Mellitus

Keywords

dutogliptin
PHX1149
DPP4 inhibitor

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

480Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Placebo Comparator	Placebo	Drug: Placebo
2	Experimental	PHX1149T 200 mg	Drug: PHX1149T
3	Experimental	PHX1149T 400 mg	Drug: PHX1149T

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PHX1149T	Drug	200 mg	2	dutogliptin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To demonstrate changes in HbA1c		Day 28 to Day 196

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Type 2 diabetes mellitus, drug naïve or willing to wash-out from existing oral therapy
BMI 25 to 48 kg/m2, inclusive
HbA1c 7.0% - 10.0%, inclusive
Age 18 to 75 years, inclusive

Exclusion Criteria:

Currently on 3 or more oral antidiabetic drugs or insulin.
Type 1 diabetes mellitus

Accepts Healthy Volunteers

No

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Norwalk	California		United States

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

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

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

Randomized

Intervention Model

Parallel Assignment

Intervention Model Description

Not provided

Primary Purpose

Treatment

Observational Model

Not provided

Time Perspective

Not provided

Masking Info

Masking

Double

Masking Description

Not provided

Who Masked

ParticipantInvestigator

PHX1149T

Drug

400 mg

3

dutogliptin

Placebo

Drug

Placebo

1

Orange

California

United States

Santa Ana

California

United States

Daytona Beach

Florida

United States

Kissimmee

Florida

United States

Atlanta

Georgia

United States

Honolulu

Hawaii

United States

Brockton

Massachusetts

United States

St Louis

Missouri

United States

Cincinnati

Ohio

United States

El Paso

Texas

United States

San Antonio

Texas

United States

Norfolk

Virginia

United States

Caba

Buenos Aires

Argentina

La Plata

Buenos Aires

Argentina

Lanus

Buenos Aires

Argentina

Paraná

Entre Ríos Province

Argentina

Salta

Salta Province

Argentina

Rosario

Santa Fe Province

Argentina

Corrientes

Argentina

Hyderabad

Andhara Pradesh

India

Bangalore

Karnataka

India

Kalaburagi

Karnataka

India

Mumbai

Maharashtra

India

Nagpur

Maharashtra

India

Nashik

Maharashtra

India

Navi Mumbai

Maharashtra

India

Pune

Maharashtra

India

Chennai

Tamil Nadu

India

Kelantan

Malaysia

Kuala Lumpur

Malaysia

Perak

Malaysia

Sarawak

Malaysia

Arequipa

Arequipa

Peru

Chiclayo-Lambayeque

Chiclayo

Peru

Lima Cercado

Lima region

Peru

Lince

Lima region

Peru

San Miguel

Lima region

Peru

San Isisdro

Lima

Peru

Manila

NCR

Philippines

Quezon City

NCR

Philippines

San Juan City

NCR

Philippines

Cebu City

VII

Philippines

Brasov

Brașov County

Romania

Jud. Brasov

Brașov County

Romania

Sector 1

Bucharest

Romania

Sector 2

Bucharest

Romania

Galati

Galați County

Romania

Ploieşti

Ploiesti

Romania

Sibiu

Sibiu County

Romania

Ratchatavi

Bangkok

Thailand

Muang

Changwat Khon Kaen

Thailand

Simferopol

Crimean Autonomy Republic

Ukraine

Ivano-Frankivsk

Ivano-Frankivsk Oblast

Ukraine

Kharkiv

Kharkiv Oblast

Ukraine

2A Postysheva Pr.

Kharkov

Ukraine

Kiev

Kyiv City

Ukraine

Kyiv

Kyiv Oblast

Ukraine

Lviv

Lviv Oblast

Ukraine

Poltava

Poltava Oblast

Ukraine

Vinnytsa

Vinnytsa

Ukraine

Zaporizhzhia

Zaporizhzhia Oblast

Ukraine

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
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Term
C552164	dutogliptin

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided