Diabetes Mellitus Clinical Trial
Official title:
A Single Blind (Sponsor-unblinded), Placebo-controlled, Parallel-group Study to Investigate the Efficacy and Safety of GSK1070806 in the Treatment of Obese Subjects With T2DM.
GSK1070806 is a humanised IgG1/kappa antibody which is directed against the soluble cytokine interleukin-18 (IL-18). The aims of this placebo controlled study are to evaluate the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of GSK1070806 in obese subjects with Type 2 diabetes mellitus (T2DM), and to gain a better understanding of the mechanism by which GSK1070806 exerts its therapeutic effects.
The study will be a randomised, single-blind (sponsor-unblinded), placebo-controlled, study
to investigate the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of
repeat intravenous infusions (2 doses 4-weeks apart) of GSK1070806 in obese patients with
T2DM. The primary objective of the study will be to assess improvements in fasting and
postprandial glucose control. This will be a parallel-group study in 30 obese subjects with
T2DM who are poorly controlled on metformin monotherapy (HbA1C>7% but <9.5%), and who have
levels of microalbuminuria indicative of progressive kidney disease i.e. 30-300mg/L albumin
in urine or ACR ≥3.5 mg/mmol (female) or ≥2.5 mg/mmol (male) and ≤30mg/mmol. There will be
three treatment groups comprising two active and one placebo arm with 10 subjects per dose
group. The study contains a broad range of biomarker assessments, the purpose of which is to
evaluate the mechanistic basis by which GSK1070806 exerts its therapeutic benefit in subjects
with T2DM.
Subjects will be randomised into one of the three treatment groups where they will receive
two intravenous infusions of GSK1070806 or placebo twenty-eight days apart. A MMT challenge
will be conducted on Day 1, Day 29, Day 57 and Day 85 for evaluation of the primary
endpoints.
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