Long-Term Safety Study to Evaluate the Safety of Dutogliptin/PHX1149T in Subjects With Type 2 Diabetes Mellitus

This study is ongoing, but not recruiting participants.

First Received: March 17, 2009 No Changes Posted

Sponsors and Collaborators:	Phenomix Forest Laboratories
Information provided by:	Phenomix
ClinicalTrials.gov Identifier:	NCT00865592

Purpose

The purpose of this study is to demonstrate that dutogliptin/PHX1149T is safe and tolerable.

Condition	Intervention	Phase
Type 2 Diabetes Mellitus Type 2 Diabetes	Drug: dutogliptin	Phase III

MedlinePlus related topics: Diabetes

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Active Control, Single Group Assignment, Safety Study
Official Title:	An Open Label, Multi-Center, Long-Term Extension Study to Evaluate the Safety of PHX1149T/Dutogliptin in Subjects With Type 2 Diabetes Mellitus

Further study details as provided by Phenomix:

Primary Outcome Measures:

To demonstrate safety and tolerability of dutogliptin [ Time Frame: Two years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To demonstrate maintenance or lowering of HbA1c [ Time Frame: Two years ] [ Designated as safety issue: Yes ]
To demonstrate maintenance or lowering of fasting blood glucose [ Time Frame: Two years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	450
Study Start Date:	March 2009
Estimated Study Completion Date:	June 2011
Estimated Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Intervention Details:

dutgliptin 400 mg, once daily tablet

Detailed Description:

In this study, open-label dutogliptin/PHX1149T will be offered to subjects who complete a Phase 3 core protocol and wish to continue treatment with dutogliptin. This will allow for the collection of long-term safety data and will also demonstrate long-term effects on HbA1c and fasting blood glucose.

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Completion of all required visits of a qualifying Phase 3 core protocol (e.g., Visit 8/Day 196 of PHX1149-PROT301)
Current treatment of Type 2 diabetes mellitus as in PHX1149-PROT301

Exclusion Criteria:

Except for Type 2 diabetes, any other uncontrolled, serious pulmonary, cardiovascular, hematologic, renal, gastrointestinal, endocrine, neurological, proliferative, immunosuppressive, psychiatric, or urogenital disorder; or diseases of skin and its appendages, the eyes, ears, nose, or throat
Any condition, disease, disorder or clinically relevant laboratory abnormality which, in the opinion of the investigator, would jeopardize the patient's appropriate participation in this study or obscure the effects of treatment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00865592

Locations

United States, California

Chula Vista, California, United States

Santa Ana, California, United States

Norwalk, California, United States

Orange, California, United States
United States, Florida

Kissimmee, Florida, United States

Daytona Beach, Florida, United States
United States, Georgia

Atlanta, Georgia, United States
United States, Massachusetts

Brockton, Massachusetts, United States
United States, Missouri

St. Louis, Missouri, United States
United States, Ohio

Cincinnati, Ohio, United States
United States, Texas

San Antonio, Texas, United States

El Paso, Texas, United States
United States, Virginia

Norfolk, Virginia, United States

Sponsors and Collaborators

Phenomix

Forest Laboratories

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Phenomix ( Hans-Peter Guler, MD )
Study ID Numbers:	PHX1149-PROT300E
Study First Received:	March 17, 2009
Last Updated:	March 17, 2009
ClinicalTrials.gov Identifier:	NCT00865592 History of Changes
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; India: Drugs Controller General of India; Malaysia: Ministry of Health; Peru: Ethics Committee; Peru: General Directorate of Pharmaceuticals, Devices, and Drugs; Philippines: Bureau of Food and Drugs; Romania: National Medicines Agency; Thailand: Ethical Committee; Thailand: Khon Kaen University Ethics Committee for Human Research; Ukraine: State Pharmacological Center - Ministry of Health

Keywords provided by Phenomix:

diabetes
DPP4-inhibitor
dutogliptin
PHX1149

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on May 06, 2009