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Клинические исследования в Украине

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Описание
Краткое названиеClinical Study to Assess the Safety and Pharmacokinetics of SRT2104 in Type 2 Diabetic Human Subjects
Полное названиеA Phase II, Randomized, Placebo-Controlled, Double-Blind, Multiple-Dose Clinical Study to Assess the Safety and Pharmacokinetics of SRT2104 in Type 2 Diabetic Human Subjects
СпонсорGlaxoSmithKline
Industry
ИсточникGlaxoSmithKline
Под контролемEstonia: State Agency of Medicines
Ukraine: Central Ethics Committee;
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Bulgaria: The Bulgarian Drug Agency
Romania: Agentia Nationala a Medicamentului
Russia: Russian Ministry of Health
Hungary: Orsz??gos Gy??gyszer?©szeti Int?©zet
Poland: URZ.D REJESTRACJI PRODUKT?“W LECZNICZYCH, WYROB?“W MEDYCZNYCH I PRODUKT?“W BIOB?“JCZYCH,CEBK
No
Краткое описаниеThe primary purpose of this study is to determine the safety and tolerability of SRT2104
(0.25, 0.5, 1.0, and 2.0 g/day) in type 2 diabetic subjects when administered once daily for
28 consecutive days, and to characterize the pharmacokinetic profile of SRT2104 after a
single dose and multiple administrations in type 2 diabetic subjects.

The secondary purpose of this study is to determine the effect of SRT2104 (0.25, 0.5, 1.0,
and 2.0 g/day) when administered once daily for 28 consecutive days on fasting blood glucose
and insulin and post-prandial blood glucose and insulin in type 2 diabetic subjects.
СостояниеЗавершено
Дата началаJuly 2009
ФазаPhase 2
Подробное описаниеStudy Objectives

Primary:

1. To determine the safety and tolerability of SRT2104 (0.25, 0.5, 1.0, and 2.0 g/day) in
type 2 diabetic subjects when administered once daily for 28 consecutive days.

2. To characterize the pharmacokinetic profile of SRT2104 (0.25, 0.5, 1.0, and 2.0 g/day)
after a single dose and multiple administrations in type 2 diabetic subjects.

Secondary:

1. To determine the effect of SRT2104 (0.25, 0.5, 1.0, and 2.0 g/day) when administered
once daily for 28 consecutive days on fasting blood glucose and insulin and post-prandial
blood glucose and insulin in type 2 diabetic subjects.

Study Design:

Prospective, multi-center, clinical study of SRT2104 administered orally once daily for 28
consecutive days; randomized, placebo-controlled, double-blind, multiple-dose,
inpatient/outpatient study to assess the safety and pharmacokinetics (PK) of SRT2104 in type
2 diabetic male and female subjects on an existing, stable, background metformin therapy.
Approximately 225 subjects aged 30-70, who fulfill the inclusion/exclusion criteria, will be
enrolled in this study to ensure completion of forty (40) evaluable subjects within each of
five dosing groups. Subjects will be evenly randomized to receive SRT2104 at one of five
doses, placebo (A), 0.25 g/day (B), 0.5 g/day (C), 1.0 g/day (D), or 2.0 g/day (E), once a
day for 28 consecutive days, approximately 15 minutes following consumption of a
standardized meal. Subjects will remain on a fixed dose of test material for all dosing
days in the study.

Subjects will sign the informed consent form at the Screening Visit, and will undergo
screening assessments over a 2-day period to verify eligibility for the study. If eligible
and willing to participate, subjects will return to the clinic within 21 days of the
Screening Visit to participate in the dosing phase of the study. Subjects will be
randomized to receive SRT2104 or placebo, and will be required to stay overnight at the
study center on Day -1 and Day 27 to gather required PK samples and to assess safety on Day
1 and Day 28 respectively. In addition, subjects will be asked to return to the study
center on Days 2 and 29; for three interim weekly safety assessments (on Days 8, 15, 22);
and for an End of Study safety assessment 7 days after they complete the 28-day dosing
period. A follow-up safety call will be made to each subject 30 days following their final
dose of SRT2104 or placebo.
Вид исследованияAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Набор0
КритерииInclusion Criteria:

1. Subjects of any race and gender within the age range of 30 to 70 years.

2. All female subjects must be of non-child-bearing potential. For the purposes of this
study, this is defined as the subject being amenorrheic for at least 12 consecutive
months, or at least 6 weeks post-surgical bilateral oophorectomy with or without
hysterectomy, or women who underwent tubal ligation. Menopausal status will be
confirmed by demonstrating levels of follicle stimulating hormone (FSH) 40 - 138
mIU/ml and oestradiol < 20 pg/ml at entry, unless this information is available in
the subject's medical record. In the event a subject's menopause status has been
clearly established (for example, the subject indicates she has been amenorrheic for
10 years), but FSH and/or oestradiol levels are not consistent with a post-menopausal
condition, determination of subject eligibility will be at the discretion of the
principal investigator following consultation with the sponsor and medical monitor

3. All male subjects must agree with their partners to use double-barrier birth control
or abstinence while participating in the study and for 12 weeks following the last
dose of study drug.

4. Willingness to provide written informed consent to participate in the study

5. HbA1c ?‰? 7.5 and ?‰¤ 10.5

6. Fasting glucose ?‰? 160 and ?‰¤ 240 mg/dL

7. Body Mass Index (BMI) ?‰? 25.0 kg/m^2 and ?‰¤ 40.0 kg/m^2

8. On stable metformin medication for at least 3 months (?‰? 1.0 g/day) prior to Screening

9. No prior history of HIV 1 or 2

10. Absence of disease markers for hepatitis B & C virus

11. Absence of significant disease or clinically significant abnormal laboratory values
on the laboratory evaluations, medical history or physical examination during the
screening; normal end organ function

12. Have a normal 12-lead ECG or one with abnormality considered to be clinically
insignificant

13. Have a normal chest X-ray (P. A. View) or one with abnormality considered to be
clinically insignificant

14. Comprehension of the nature and purpose of the study and compliance with the
requirement of the entire protocol

Exclusion Criteria:

1. Any major illness in the past three months or any significant ongoing chronic medical
illness not related to diabetes

2. Renal or liver impairment, defined as serum creatinine level of ?‰? 1.4 mg/dL for
females and ?‰? 1.5 mg/dL for males, and greater than two times the upper limit of
normal for liver enzymes, respectively.

3. History of or current gastro-intestinal diseases influencing drug absorption, except
for appendectomy

4. History, within 3 years, of drug abuse (including Benzodiazepines, opioids,
amphetamine, cocaine, and THC)

5. History of alcoholism (more than two years), moderate drinkers (more than three
drinks per day) or having consumed alcohol within 48 hrs prior to dosing [one drink
is equal to one unit of alcohol (one glass wine, half pint beer, one measure of
spirit)]

6. Participation in any clinical trial within the past three months

7. History of difficulty in donating blood or accessibility of veins in left or right
arm

8. Donation of blood (one unit or 350 ml) within three months prior to receiving the
first dose of test material

9. Use of any prescription drug therapy, with exception of any prescription medication
administered at a stable dose for at least 6 weeks prior to Screening, provided the
medication is not contraindicated by the metformin label

10. Use of any alternate anti-diabetic therapy, except metformin, within three months of
enrollment
ПолBoth
Минимальный возраст30 Years
Максимальный возраст70 Years
УсловиеDiabetes Mellitus, Type 2
Применяемое лечение
DrugSRT2104
DrugPlacebo
Контакты и расположение
Kharkiv , 61022GSK Investigational Site
Mykolaiv , 54003GSK Investigational Site
Simferopol , 95017GSK Investigational Site
Ternopil , 46001GSK Investigational Site
Vinnitsa , 21010GSK Investigational Site
Zaporizhzhya , 69035GSK Investigational Site
Zaporizhzhya , 69001GSK Investigational Site
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