Diabetes - type 2 MedDRA version: 9.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus
Conditions
Interventions
Product Name: SRT-2104
Product Code: SRT-2104
Pharmaceutical Form: Capsule*
Current Sponsor code: SRT-2104
Other descriptive name: SRT-2104
Concentration unit: mg milligram(s)
Concentration type: equa
Sponsors
Sirtris Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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 160 and 25.0 kg/m2 and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objectives of this study are: Safety: 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. Pharmacokinetics: 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 Objective: Activity: To determine the effect of SRT2104 (0.25, 0.5, 1.0, and 2.0 g/day) on fasting blood glucose and insulin and post-prandial glucose and insulin in type 2 diabetic subjects when administered once daily for 28 consecutive days. Exploratory biomarker/research endpoints will be analysed (e.g. FGF-21);Primary end point(s): 1) Pharmacokinetics (assessed at Day 1 and Day 28) 2) Safety (assessed throughout the study) | — |
Countries
Bulgaria, Estonia, Hungary, Poland, United Kingdom
Outcome results
None listed