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

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00865592
• Other study ID #: PHX1149-PROT300E
• Status: Terminated
• Phase: Phase 3
• First received: March 17, 2009
• Last updated: August 10, 2010
• Start date: March 2009
• Est. completion date: March 2011

Study information

• Verified date: August 2010
• Source: Phenomix
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review BoardArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaIndia: Drugs Controller General of IndiaMalaysia: Ministry of HealthPeru: Ethics CommitteePeru: General Directorate of Pharmaceuticals, Devices, and DrugsPhilippines: Bureau of Food and DrugsRomania: National Medicines AgencyThailand: Ethical CommitteeThailand: Khon Kaen University Ethics Committee for Human ResearchUkraine: State Pharmacological Center - Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 450
• Est. completion date: March 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes
• Type 2 Diabetes Mellitus

Intervention

Drug:
• dutogliptin
dutogliptin 400 mg, once daily tablet

Locations

Country	Name	City	State
Argentina	Phenomix Investigational Site 103	Buenos Aires
Argentina	Phenomix Investigational Site 110	Buenos Aires
Argentina	Phenomix Investigational Site 111	Buenos Aires
Argentina	Phenomix Investigational Site 106	Caba
Argentina	Phenomix Investigational Site 112	Corrientes
Argentina	Phenomix Investigational Site 102	Paraná
Malaysia	Phenomix Investigational Site 403	Kuching	Sarawak
Malaysia	Phenomix Investigational Site 404	Putrajaya
Peru	Phenomix Investigational Site 604	Arequipa
Peru	Phenomix Investigational Site 606	Lambayeque
Peru	Phenomix Investigational Site 600	Lima
Peru	Phenomix Investigational Site 601	Lima
Peru	Phenomix Investigational Site 602	Lima
Peru	Phenomix Investigational Site 609	Lima
Philippines	Phenomix Investigational Site 703	Cebu City
Romania	Phenomix Investigational Site 802	Brasov
Romania	Phenomix Investigational Site 806	Brasov
Romania	Phenomix Investigational Site 800	Bucharest
Romania	Phenomix Investigational Site 803	Bucharest
Romania	Phenomix Investigational Site 805	Bucharest
Romania	Phenomix Investigational Site 807	Bucharest
Romania	Phenomix Investigational Site 804	Galati
Romania	Phenomix Investigational Site 801	Ploiesti
Romania	Phenomix Investigational Site 808	Sibiu
Ukraine	Phenomix Investigational Site 551	Ivano-Frankivsk
Ukraine	Phenomix Investigational Site 557	Kharkiv
Ukraine	Phenomix Investigational Site 564	Kharkiv
Ukraine	Phenomix Investigational Site 550	Kharkov
Ukraine	Phenomix Investigational Site 555	Kiev
Ukraine	Phenomix Investigational Site 556	Kiev
Ukraine	Phenomix Investigational Site 562	Kiev
Ukraine	Phenomix Investigational Site 563	Kiev
Ukraine	Phenomix Investigational Site 554	Kylv
Ukraine	Phenomix Investigational Site 565	Lutsk
Ukraine	Phenomix Investigational Site 553	Lviv
Ukraine	Phenomix Investigational Site 561	Poltava
Ukraine	Phenomix Investigational Site 560	Simferopol
Ukraine	Phenomix Investigational Site 559	Vinnitsa
Ukraine	Phenomix Investigational Site 552	Zaporzhzhia
United States	Phenomix Investigational Site 663	Honolulu	Hawaii

Sponsors (2)

Lead Sponsor	Collaborator
Phenomix	Forest Laboratories

Countries where clinical trial is conducted

United States,  Argentina,  India,  Malaysia,  Peru,  Philippines,  Romania,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To demonstrate safety and tolerability of dutogliptin		Two years	Yes
Secondary	To demonstrate maintenance or lowering of HbA1c		Two years	Yes
Secondary	To demonstrate maintenance or lowering of fasting blood glucose		Two years	Yes