A 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
- Conditions
- Diabetes - type 2MedDRA version: 9.1Level: LLTClassification code 10045242Term: Type II diabetes mellitus
- Registration Number
- EUCTR2009-010720-26-GB
- Lead Sponsor
- Sirtris Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 225
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/m2 and < 40.0 kg/m2
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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objectives of this study are:<br>Safety: To determine the safety and tolerability of SRT2104 (0.25, 0.5, 1.0, and 2.0<br>g/day) in type 2 diabetic subjects when administered once daily for 28 consecutive<br>days.<br>Pharmacokinetics: To characterize the pharmacokinetic profile of SRT2104 (0.25,<br>0.5, 1.0, and 2.0 g/day) after a single dose and multiple administrations in type 2<br>diabetic subjects.;Secondary Objective: Activity: To determine the effect of SRT2104 (0.25, 0.5, 1.0, and 2.0 g/day) on<br>fasting blood glucose and insulin and post-prandial glucose and insulin in type 2<br>diabetic subjects when administered once daily for 28 consecutive days.<br><br>Exploratory biomarker/research endpoints will be analysed (e.g. FGF-21);Primary end point(s): 1) Pharmacokinetics (assessed at Day 1 and Day 28)<br>2) Safety (assessed throughout the study)<br>
- Secondary Outcome Measures
Name Time Method