dose ranging study of albiglutide in japanese subjects

Conditions: Diabetes Mellitus, Type 2

Summary: this is a randomized, double-blind, placebo-controlled, multicenter, 4-parallel-group, dose ranging study evaluating the dose response, efficacy and safety of subcutaneously injected gsk716155 (albiglutide) in japanese subjects with type 2 diabetes mellitus.

this is a phase iib, randomized, double-blind, placebo-controlled, multicenter, 4-parallel-group, dose ranging, superiority study evaluating the dose response, efficacy and safety of weekly and every other week subcutaneously injected gsk716155 (albiglutide) in subjects with type 2 diabetes mellitus.

Eligibility criteria:
inclusion criteria: * subject with a historical diagnosis of type 2 diabetes mellitus who is currently treated with diet and exercise only or one oad * bmi ≥18 kg/m2 and \<35 kg/m2 at screening * hba1c between 7.0% and 10.0%, inclusive * fasting c-peptide ≥0.8 ng/ml (≥0.26 nmol/l) * female subjects of childbearing potential must be practicing adequate contraception . * able and willing to monitor his/her own blood glucose concentrations with a home glucose monitor. * able and willing to provide written informed consent exclusion criteria: * diagnosis of type 1 diabetes mellitus * uncorrected thyroid dysfunction * previous use of insulin within one month prior to screening, or more than seven total days of insulin treatment within three months prior to screening * clinically significantly cardiovascular and/or cerebrovascular disease including, but not limited to the following: * previous history of stroke or transient ischemic attack * active, unstable coronary heart disease within the past six months before screening * documented myocardial infarction within one year before screening * any cardiac surgery including percutaneous transluminal coronary angioplasty, coronary stent placement, or coronary artery bypass graft surgery within one year before screening * unstable angina * clinically significant arrhythmia or valvular heart disease * current heart failure nyha class ii to iv * resting systolic pressure \>160 mm hg or diastolic pressure \>95 mm hg at screening * ecg criteria at screening * heart rate: \ 110 bpm * pr interval: \ 210 msec * qrs interval: \ 120 msec * qtc interval (bazett): \>450 msec or \>480 msec with bundle branch block * fasting triglyceride level \>400 mg/dl at screening * ast or alt \>2xuln, alp and bilirubin \>1.5xuln (except known gilbert's syndrome and a fractionated bilirubin that shows conjugated bilirubin \<35% of total bilirubin) * if female, is currently lactating, within 6 weeks post-partum, pregnant, or actively trying to become pregnant * has significant renal disease as manifested by one or more of the following: * creatinine clearance at screening \<60 ml/min (calculated by cockcroft-gault formula) at screening * known loss of a kidney either by surgical ablation, injury or disease level * a hemoglobinopathy that may affect determination of hba1c level * history of treated diabetic gastroparesis * history of significant gastrointestinal surgery, including gastric bypass and banding, or surgeries thought to significantly affect upper gastrointestinal function * current ongoing symptomatic biliary disease or history of acute/chronic pancreatitis. * lipase and amylase at screening \> uln * severe diabetic neuropathy, preproliferative retinopathy or proliferative retinopathy, history of ketoacidosis or hyperosmolar coma * history of cancer, other than squamous cell or basal cell carcinoma of the skin, that has not been in full remission for at least 3 years before screening. (a history of treated cervical intraepithelial neoplasia i or cervical intraepithelial neoplasia ii is allowed) * acute or chronic history of liver disease, positive hepatitis b surface antigen (hbsag) or positive hepatitis c testing at screening * current and history of alcohol or substance abuse * clinically significant anaemia or any other abnormal haematological profile that is considered by the investigator to be clinically significant * prior use of a glp-1 analog * known allergy to any formulation excipients, or baker's yeast, or history of drug, or other allergy which, in the opinion of the responsible study physician, contradicts participation * history of or family history of medullary carcinoma of the thyroid. * history of or family history of multiple endocrine neoplasia type 2 * receipt of any investigational drug within the 12 weeks before screening

Keywords: dose-ranging pharmacokinetics gsk716155 japan albiglutide