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

NCT00865592 | Terminated Phase 3

• 1 other identifier: PHX1149-PROT300E
• Study Type: interventional
• Target: 450
• Locations: 8 countries
• Sites: 68

Brief Summary

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

Conditions

Type 2 Diabetes Mellitus; Type 2 Diabetes

Keywords

diabetes; DPP4 inhibitor; dutogliptin; PHX1149

Outcome Measures

Primary Outcomes (1)

• To demonstrate safety and tolerability of dutogliptin

  Two years

Secondary Outcomes (2)

• To demonstrate maintenance or lowering of HbA1c

  Two years

• To demonstrate maintenance or lowering of fasting blood glucose

  Two years

Interventions

dutogliptin DRUG

dutogliptin 400 mg, once daily tablet

Also known as: PHX1149T, PHX1149, dutogliptin tartrate

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Phenomix: lead
• Forest Laboratories: collaborator

Study Sites (68)

Unknown Facility

Norwalk, California, United States

Location

Unknown Facility

Orange, California, United States

Location

Unknown Facility

Santa Ana, California, United States

Location

Unknown Facility

Daytona Beach, Florida, United States

Location

Unknown Facility

Kissimmee, Florida, United States

Location

Unknown Facility

Atlanta, Georgia, United States

Location

Phenomix Investigational Site 663

Honolulu, Hawaii, United States

Location

Unknown Facility

Brockton, Massachusetts, United States

Location

Unknown Facility

St Louis, Missouri, United States

Location

Unknown Facility

Cincinnati, Ohio, United States

Location

Unknown Facility

El Paso, Texas, United States

Location

Unknown Facility

San Antonio, Texas, United States

Location

Unknown Facility

Norfolk, Virginia, United States

Location

Phenomix Investigational Site 103

Buenos Aires, Argentina

Location

Phenomix Investigational Site 110

Buenos Aires, Argentina

Location

Phenomix Investigational Site 111

Buenos Aires, Argentina

Location

Phenomix Investigational Site 106

Caba, Argentina

Location

Phenomix Investigational Site 112

Corrientes, Argentina

Location

Phenomix Investigational Site 102

Paraná, Argentina

Location

Unknown Facility

Bangalore, Karnataka, India

Location

Unknown Facility

Chennai, Tamil Nadu, India

Location

Unknown Facility

Gulbarga, Karnataka, India

Location

Unknown Facility

Hyderabad, Andhara Pradesh, India

Location

Unknown Facility

Mumbai, Maharashtra, India

Location

Unknown Facility

Nagpur, Maharashtra, India

Location

Unknown Facility

Nashik, Maharashtra, India

Location

Unknown Facility

Navi Mumbai, Maharashtra, India

Location

Unknown Facility

Pune, Maharashtra, India

Location

Phenomix Investigational Site 403

Kuching, Sarawak, Malaysia

Location

Unknown Facility

Kelantan, Malaysia

Location

Unknown Facility

Kuala Lumpur, Malaysia

Location

Unknown Facility

Perak, Malaysia

Location

Phenomix Investigational Site 404

Putrajaya, Malaysia

Location

Unknown Facility

Sarawak, Malaysia

Location

Phenomix Investigational Site 604

Arequipa, Peru

Location

Phenomix Investigational Site 606

Lambayeque, Peru

Location

Phenomix Investigational Site 600

Lima, Peru

Location

Phenomix Investigational Site 601

Lima, Peru

Location

Phenomix Investigational Site 602

Lima, Peru

Location

Phenomix Investigational Site 609

Lima, Peru

Location

Phenomix Investigational Site 703

Cebu City, Philippines

Location

Unknown Facility

Manila, NCR, Philippines

Location

Unknown Facility

Quezon City, NCR, Philippines

Location

Unknown Facility

San Juan, NCR, Philippines

Location

Phenomix Investigational Site 802

Brasov, Romania

Location

Phenomix Investigational Site 806

Brasov, Romania

Location

Phenomix Investigational Site 800

Bucharest, Romania

Location

Phenomix Investigational Site 803

Bucharest, Romania

Location

Phenomix Investigational Site 805

Bucharest, Romania

Location

Phenomix Investigational Site 807

Bucharest, Romania

Location

Phenomix Investigational Site 804

Galati, Romania

Location

Phenomix Investigational Site 801

Ploieşti, Romania

Location

Phenomix Investigational Site 808

Sibiu, Romania

Location

Phenomix Investigational Site 551

Ivano-Frankivsk, Ukraine

Location

Phenomix Investigational Site 550

Kharkiv, Ukraine

Location

Phenomix Investigational Site 557

Kharkiv, Ukraine

Location

Phenomix Investigational Site 564

Kharkiv, Ukraine

Location

Phenomix Investigational Site 555

Kiev, Ukraine

Location

Phenomix Investigational Site 556

Kiev, Ukraine

Location

Phenomix Investigational Site 562

Kiev, Ukraine

Location

Phenomix Investigational Site 563

Kiev, Ukraine

Location

Phenomix Investigational Site 554

Kylv, Ukraine

Location

Phenomix Investigational Site 565

Lutsk, Ukraine

Location

Phenomix Investigational Site 553

Lviv, Ukraine

Location

Phenomix Investigational Site 561

Poltava, Ukraine

Location

Phenomix Investigational Site 560

Simferopol, Ukraine

Location

Phenomix Investigational Site 559

Vinnitsa, Ukraine

Location

Phenomix Investigational Site 552

Zaporzhzhia, Ukraine

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

dutogliptin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 17, 2009
• First Posted: March 19, 2009
• Study Start: March 1, 2009
• Primary Completion: January 1, 2011
• Study Completion: March 1, 2011
• Last Updated: August 11, 2010

Record last verified: 2010-08

Locations

AR (6); PE (6); PH (4); RO (9); US (13); MY (6); IN (9); UA (15)