Клинические исследования в Украине

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Исследования / № 00461006

Краткое названиеA Comparison of the Effects of Aleglitazar and Actos on Renal Function on Patients With Type 2 Diabetes.
Полное названиеA Randomized, Double Blind Study to Compare the Effects of Aleglitazar and Actos on Glomerular Filtration Rate and Other Parameters of Renal Function in Patients With Type 2 Diabetes.
СпонсорHoffmann-La Roche
ИсточникHoffmann-La Roche
Под контролемUnited States: Food and Drug Administration
Краткое описаниеThis 2 arm study will compare the effects of aleglitazar and Actos, added to preexisting
oral antihyperglycemic therapy and/or diet and exercise, on renal function in patients with
type 2 diabetes, and normal or mildly impaired renal function. Eligible patients will be
randomized to receive either aleglitazar 0.6mg p.o. or Actos 45mg p.o. daily. Renal function
and efficacy parameters will be assessed at intervals during the treatment period. The
anticipated time on study treatment is 3-12 months, and the target sample size is 100-500
ФазаPhase 2
Вид исследованияAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
КритерииInclusion Criteria:

- adult patients, 18-75 years of age;

- type 2 diabetes for >=1 month;

- drug naive, or receiving stable oral antihyperglycemic medication;

- HbAlc 6.5-10.0% at screening.

Exclusion Criteria:

- type 1 diabetes;

- current or previous treatment with insulin;

- history of renal disease other than diabetic nephropathy;

- uncontrolled hypertension;

- clinically significant cardiovascular disease;

- CHF NYHA 3-4.
Минимальный возраст18 Years
Максимальный возраст75 Years
УсловиеDiabetes Mellitus, Type 2
Применяемое лечение
Контакты и расположение
Dnipropetrovs'k , 49005
Dnipropetrovs'k , 49060
Donetsk , 83114
Donetsk , 83003
Kharkiv , 61039
Kharkov , 61178
Kiev , 02091
Kiev , 2091
Kiev , 2125
Lugnansk , 91045
Poltava , 36024
Ternopil , 46002
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