Клинические исследования в Украине

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Краткое название12 Weeks Treatement With 3 Different Doses of BI 10773 in Type 2 Diabetic Patients
Полное названиеA Phase IIb, Randomized, Parallel Group Safety, Efficacy, and Pharmacokinetics Study of BI 10773 (5 mg, 10 mg and 25 mg) Administered Orally Once Daily Over 12 Weeks Compared Double Blind to Placebo, as Monotherapy, With an Additional Open-label Metformin Arm in Type 2 Diabetic Patients With Insufficient Glycemic Control
СпонсорBoehringer Ingelheim Pharmaceuticals
ИсточникBoehringer Ingelheim Pharmaceuticals
Под контролемArgentina: A.N.M.A.T. (National Administration of Medications, Food and Medical Technology)
Croatia: Croatian Institute for Medicines Control, HR-10000 Zagreb
Estonia: State Agency of Medicines, EE-5041Tartu
Germany: Federal Institute for Drugs and Medical Devices
Italy: Comitato per la Sperimentazione Clinica dei Medicinali Azienda Ospedaliero-Universitaria Pisana
Korea, Republic of: Korea Food and Drug Administration (KFDA)
Lithuania: State Medicines Control Agency, LT-01132 Vilnius
Romania: National Medicines Agency, Bucharest
Russia: Ministry of Healthcare and Social Development of Russian Federation, Moscow
Slovakia: SUKL (state institute for drug control), SK-825 08 Bratislava 26
Sweden: Medical Products Agency, Box 26, 751 03 Uppsala, Sweden Regional Ethical Review Board of Stockholm, PO Box 289, SE-171 77 Stockholm, Sweden.
Taiwan: Department of Health, Executive Yuan, Taiwan
Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine)
Краткое описаниеThe objective is to investigate the efficacy, safety and pharmacokinetics of three different
doses of BI 10773 compared to placebo given for 12 weeks in patients with type 2 diabetes
mellitus with insufficient glycemic control. In addition an open-label metformin arm will be
Дата началаOctober 2008
ФазаPhase 2
Вид исследованияEndpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment
КритерииInclusion Criteria:

- Male and female patients with a diagnosis of type 2 diabetes mellitus

- HbA1c between 7% and 10%

- Age between 18 and 80 years

- BMI less than 40 kg/m2

- Signed and dated informed consent prior to admission to the study in accordance with
GCP and local legislation

Exclusion Criteria:

1. Myocardial infarction, stroke or TIA within 6 months prior to informed consent

2. Impaired hepatic function

3. Renal insufficiency or impaired renal function

4. Disease of central nervous system, or psychiatric disorders or clinically relevant
neurologic disorders that may interfere with trial participation

5. Chronic or clinically relevant acute infections

6. Current or chronic urogenital tract infection determined by medical history

7. History of clinically relevant allergy/hypersensitivity

8. Treatment with glitazones, GLP-1 analogues or insulin within 3 months prior to
informed consent

9. Treatment with anti obesity drugs

10. Current treatment with systemic steroids

11. Alcohol abuse

12. Treatment with an investigational drug within 2 months prior to informed consent

13. Intolerance to metfomin

14. Dehydration

15. Unstable or acute CHF

16. Acute or chronic acidosis

17. Hereditary galactose intolerance

18. Woman of child bearing potential who are nursing or pregnant or not practicing an
acceptable method of birth control
Минимальный возраст18 Years
Максимальный возраст80 Years
УсловиеDiabetes Mellitus, Type 2
Применяемое лечение
DrugBI 10773
Контакты и расположение
Kharkov 1245.9.38003 Boehringer Ingelheim Investigational Site
Kiev 1245.9.38004 Boehringer Ingelheim Investigational Site
Odessa 1245.9.38002 Boehringer Ingelheim Investigational Site
Vinnytsya 1245.9.38005 Boehringer Ingelheim Investigational Site
Vinnytsya 1245.9.38001 Boehringer Ingelheim Investigational Site
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