Status:
COMPLETED
Clinical Study to Assess the Safety and Pharmacokinetics of SRT2104 in Type 2 Diabetic Human Subjects
Lead Sponsor:
Sirtris, a GSK Company
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
30-70 years
Phase:
PHASE2
Brief Summary
The 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 day...
Detailed Description
Study 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. ...
Eligibility Criteria
Inclusion
- Subjects of any race and gender within the age range of 30 to 70 years.
- 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
- 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.
- Willingness to provide written informed consent to participate in the study
- HbA1c ≥ 7.5 and ≤ 10.5
- Fasting glucose ≥ 160 and ≤ 240 mg/dL
- Body Mass Index (BMI) ≥ 25.0 kg/m\^2 and ≤ 40.0 kg/m\^2
- On stable metformin medication for at least 3 months (≥ 1.0 g/day) prior to Screening
- No prior history of HIV 1 or 2
- Absence of disease markers for hepatitis B \& C virus
- 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
- Have a normal 12-lead ECG or one with abnormality considered to be clinically insignificant
- Have a normal chest X-ray (P. A. View) or one with abnormality considered to be clinically insignificant
- Comprehension of the nature and purpose of the study and compliance with the requirement of the entire protocol
Exclusion
- Any major illness in the past three months or any significant ongoing chronic medical illness not related to diabetes
- 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.
- History of or current gastro-intestinal diseases influencing drug absorption, except for appendectomy
- History, within 3 years, of drug abuse (including Benzodiazepines, opioids, amphetamine, cocaine, and THC)
- 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 \[one drink is equal to one unit of alcohol (one glass wine, half pint beer, one measure of spirit)\]
- Participation in any clinical trial within the past three months
- History of difficulty in donating blood or accessibility of veins in left or right arm
- Donation of blood (one unit or 350 ml) within three months prior to receiving the first dose of test material
- 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
- Use of any alternate anti-diabetic therapy, except metformin, within three months of enrollment
Key Trial Info
Start Date :
August 19 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 18 2010
Estimated Enrollment :
227 Patients enrolled
Trial Details
Trial ID
NCT00937326
Start Date
August 19 2009
End Date
September 18 2010
Last Update
July 13 2018
Active Locations (61)
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1
GSK Investigational Site
Byala, Bulgaria, 7100
2
GSK Investigational Site
Dimitrovgrad, Bulgaria, 6400
3
GSK Investigational Site
Haskovo, Bulgaria, 6300
4
GSK Investigational Site
Pleven, Bulgaria, 5800