Track topics on Twitter Track topics that are important to you
Randomized, placebo-controlled, parallel-group, double-blind, multiple-dose, activity and safety clinical study of SRT2104 administered orally once daily for 28 consecutive days. This will be an inpatient/outpatient study to assess the safety and pharmacokinetics of SRT2104 in type 2 diabetic male and female subjects on an existing, stable, background metformin therapy. Approximately 80 subjects will be enrolled. Subjects will be evenly randomized to receive SRT2104 2.0 g/day or placebo in the fed state.
Subjects will be required to stay overnight at the study center on Days -2, -1, 0, 1 (optional discharge at investigator's discretion), 27, 28, 41, and 42. During these admissions, pharmacokinetic, biomarker and glycated albumin samples will be collected, and glucose profiling, OGTT, glucose stabilization, hyperinsulinemc euglycemic clamp (HEGC) studies with indirect calorimetry and various other safety and activity procedures will be performed. On Day 1 of the study, subjects will be randomized to receive SRT2104 or placebo. Day 43 will be the last day of the study and subjects will be released. In addition, subjects will be asked to return to the study center on Day 14 for interim safety assessments.
During the dosing period, study personnel will contact subjects by telephone on Days 7 and 21 to conduct a safety assessment. Subjects will be required to monitor their fasting blood glucose and complete a daily diary for the outpatient portion of the study between Days 1 and 28. A follow-up, safety phone call will occur 30 days following their final dose of SRT2104 or placebo (Day 58 of the study) to identify any possible additional adverse events or concomitant medications.
Randomized, placebo-controlled, parallel-group, double-blind, multiple-dose, activity and safety clinical study of SRT2104 administered orally once daily for 28 consecutive days. This will be an inpatient/outpatient study to assess the safety and pharmacokinetics (PK) of SRT2104 in type 2 diabetic (T2D) male and female subjects on an existing, stable, background metformin therapy. Approximately 112 subjects aged 18-65 years, who fulfill the inclusion/exclusion criteria, will be screened for this study to enroll approximately 80 subjects. Subjects will be evenly randomized to receive SRT2104 2.0 g/day or placebo approximately 15 minutes following consumption of a standardized morning 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 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 pre-dosing phase of the study. On Day 1 of the study, subjects will be randomized to receive SRT2104 or placebo. Subjects will be required to stay overnight at the study center on Days -2, -1, 0, 1 (optional discharge at investigator's discretion), 27, 28, 41, and 42 for testing, to assess safety, and to gather required biomarker samples. In addition, subjects will be asked to return to the study center on Day 14 for interim safety assessments. The subject will be telephoned on Days 7 and 21 to assess safety. Subjects will be required to monitor their fasting blood glucose and complete a daily diary for the outpatient portion of the study between Days 1 and 28. A follow-up, safety phone call will occur 30 days following their final dose of SRT2104 or placebo (Day 58 of the study) to identify any possible additional adverse events (AEs) or concomitant medications.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)
Diabetes Mellitus, Type 2
GSK Investigational Site
Published on BioPortfolio: 2014-08-27T03:17:49-0400
The primary purpose of this study is to evaluate the safety and tolerability of SRT2104 (2.0 g administered once daily for 28 days) and to examine the effects of SRT2104 (2.0 g administere...
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 con...
SRT2104 is a potent small molecule activator of SIRT1 that has been found to inhibit systemic inflammation induced by intravenous injection of lipopolysaccharide (LPS) in mice. The objecti...
The primary objective is to determine the pharmacokinetics, safety and tolerability of SRT2104 in healthy elderly subjects following single and 28 days dosing. The secondary objectives of...
This is a clinical study to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.
Obesity and type 2 diabetes mellitus are prevalent all over the world. Obese patients with more visceral fat are more likely to suffer from type 2 diabetes mellitus, hypertension, dyslipidemia and obs...
Diabetes mellitus (DM) carries an elevated risk for cardiovascular disease. Here, we assessed alirocumab efficacy and safety in people with/without DM from five placebo-controlled phase 3 studies.
Despite improved understanding of the pathophysiology of type 2 diabetes mellitus, explanations for individual variability in disease progression and response to treatment are incomplete. The gut micr...
Milk Powder Co-Supplemented with Inulin and Resistant Dextrin Improves Glycemic Control and Insulin Resistance in Elderly type 2 Diabetes Mellitus: a 12-Week Randomized, Double-Blind, Placebo-Controlled Trial.
The objective of the present study was to evaluate the effects of milk powder co-supplemented with inulin and resistant dextrin (MPCIR) on elderly patients of type 2 diabetes mellitus (T2DM).
Atherosclerotic cardiovascular disease is the leading cause of mortality of patients with type 2 diabetes mellitus, and both coronary artery disease (CAD) and diabetes mellitus are associated with inf...
A subclass of DIABETES MELLITUS that is not INSULIN-responsive or dependent (NIDDM). It is characterized initially by INSULIN RESISTANCE and HYPERINSULINEMIA; and eventually by GLUCOSE INTOLERANCE; HYPERGLYCEMIA; and overt diabetes. Type II diabetes mellitus is no longer considered a disease exclusively found in adults. Patients seldom develop KETOSIS but often exhibit OBESITY.
The time period before the development of symptomatic diabetes. For example, certain risk factors can be observed in subjects who subsequently develop INSULIN RESISTANCE as in type 2 diabetes (DIABETES MELLITUS, TYPE 2).
A subtype of DIABETES MELLITUS that is characterized by INSULIN deficiency. It is manifested by the sudden onset of severe HYPERGLYCEMIA, rapid progression to DIABETIC KETOACIDOSIS, and DEATH unless treated with insulin. The disease may occur at any age, but is most common in childhood or adolescence.
A type of diabetes mellitus that is characterized by severe INSULIN RESISTANCE and LIPODYSTROPHY. The latter may be generalized, partial, acquired, or congenital (LIPODYSTROPHY, CONGENITAL GENERALIZED).
A life-threatening complication of diabetes mellitus, primarily of TYPE 1 DIABETES MELLITUS with severe INSULIN deficiency and extreme HYPERGLYCEMIA. It is characterized by excessive LIPOLYSIS, oxidation of FATTY ACIDS, production of KETONE BODIES, a sweet smell to the breath (KETOSIS;) DEHYDRATION; and depressed consciousness leading to COMA.
Diabetes is a lifelong condition that causes a person's blood sugar level to become too high. The two main types of diabetes are: type 1 diabetes type 2 diabetes In the UK, diabetes affects approximately 2.9 million people. There are a...
Of all the types of Dementia, Alzheimer's disease is the most common, affecting around 465,000 people in the UK. Neurons in the brain die, becuase 'plaques' and 'tangles' (mis-folded proteins) form in the brain. People with Al...