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Описание
Краткое названиеLong-term Study to Evaluate the Safety of Dutogliptin/PHX1149T in Subjects With Type 2 Diabetes Mellitus
Полное названиеAn Open Label, Multi-Center, Long-Term Extension Study to Evaluate the Safety of PHX1149T/Dutogliptin in Subjects With Type 2 Diabetes Mellitus
СпонсорPhenomix
Industry
ИсточникPhenomix
Под контролемUnited 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
No
Краткое описаниеThe purpose of this study is to demonstrate that dutogliptin/PHX1149T is safe and tolerable.
СостояниеОтменено
Дата началаMarch 2009
ФазаPhase 3
Подробное описаниеIn 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.
Вид исследованияControl: Active Control, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Набор0
КритерииInclusion 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
ПолBoth
Минимальный возраст18 Years
Максимальный возраст85 Years
УсловиеType 2 Diabetes Mellitus
Применяемое лечение
Drugdutogliptin
Контакты и расположение
Ivano-Frankivsk Phenomix Investigational Site 551
Kharkiv Phenomix Investigational Site 564
Kharkiv Phenomix Investigational Site 557
Kharkov Phenomix Investigational Site 550
Kiev Phenomix Investigational Site 556
Kiev Phenomix Investigational Site 563
Kiev Phenomix Investigational Site 562
Kiev Phenomix Investigational Site 555
Kylv Phenomix Investigational Site 554
Lutsk Phenomix Investigational Site 565
Lviv Phenomix Investigational Site 553
Poltava Phenomix Investigational Site 561
Simferopol Phenomix Investigational Site 560
Vinnitsa Phenomix Investigational Site 559
Zaporzhzhia Phenomix Investigational Site 552
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