A Phase II, 16-week, double-blind, placebo-controlled, parallel-group, randomized, multicenter trial to assess effect on glycaemic control of three doses of HM11260C in subjects with inadequately controlled type 2 diabetes receiving a stable dose of metformin
The purpose of this study is to determine the optimal dose or doses of HM11260C, when administered monthly under the skin, to improve the control of blood sugar levels in patients with inadequately controlled T2DM who are receiving a stable dose of metformin. The optimal dose will be determined based on the efficacy (effects on HbA1c), safety and tolerability of three HM11260C doses compared with placebo. Data from this study will be used to assist in the design of the Phase 3 study, which will assess the safety and effectiveness of HM11260C as a treatment to improve the control of blood sugar levels in patients with T2DM. Primary objective is to assess and compare the efficacy of three doses of HM11260C (once monthly dosing) versus placebo on glycaemic control as assessed by the change in HbA1c over the 16 weeks from baseline in subjects with T2DM receiving a stable dose of metformin.
Keywordsglycaemic, HM11260C, type 2 diabetes, metformin, blood sugar
Principal InvestigatorMae Sheikh-Ali
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