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A Randomized, Double-blind, Placebo-controlled Study of the Effect of 49 Days of Treatment With Repeated Subcutaneous Doses of HIP2B to Assess Safety, Tolerability and Measures of Islet β-cell Function in Subjects With Type 2 Diabetes Mellitus Treated With Metformin
HIP2B is being developed for the treatment of type 1 and type 2 diabetes mellitus.
The purpose of this study is to investigate the safety and tolerability of repeat doses of HIP2B in subjects with type 2 diabetes mellitus. The study will also assess whether islet β-cell number and function will increase over time in response to repeat HIP2B injections.
A Randomized, Double-blind, Third Party (Sponsor) Open, Placebo-controlled Study of the Tolerability and Pharmacokinetics of Single Ascending Subcutaneous Doses of HIP2B in Healthy Male Subjects
HIP2B is the stabilized form of the Human proIslet Peptide (HIP). Human proIslet Peptide is the human homolog of Islet Neogenesis Associated Protein (INGAP) peptide, which has shown signals of efficacy in type 1 and type 2 diabetes mellitus. In a mouse model of diabetes, repeat dose treatment with HIP results in new islet formation and improvement in blood glucose measurements.
HIP2B is being developed for the treatment of type 1 and type 2 diabetes mellitus.
The present clinical trial protocol proposes the first administration of HIP2B to humans with the goal of exploring the tolerability, safety and PK of HIP2B following subcutaneous single ascending doses.
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