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.

Start Date01 Aug 2013

Sponsor / Collaborator

Cure DM, Inc.

[+1]

NCT01638611 / CompletedPhase 1

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.

Start Date01 Jul 2012

Sponsor / Collaborator

Cure DM, Inc.

[+1]

100 Clinical Results associated with Human proislet peptide

100 Translational Medicine associated with Human proislet peptide

100 Patents (Medical) associated with Human proislet peptide

Literatures (Medical) associated with Human proislet peptide

01 Jul 2018·Diabetes

Human Proislet Peptide Promotes Pancreatic Progenitor Cells to Ameliorate Diabetes Through FOXO1/Menin-Mediated Epigenetic Regulation

Article

Author: Jiang, Zongzhe ; Shi, Diwen ; Gustafsson, Jan-Åke ; Zhang, Wenjian ; Liu, Suhuan ; Tian, Jingjing ; Ma, Xiaosong ; Xing, Bowen ; Hua, Xianxin ; Tu, Yifan ; Lou, Jinning ; Wang, Jihua

We investigated how human proislet peptide (HIP) regulates differentiation of human fetus–derived pancreatic progenitor cells (HFPPCs) and explored the potential link between HIP signaling and the menin pathway, which is key to regulating pancreatic islet differentiation. The data show that HIP promoted expression of proislet transcription factors (TFs), including PDX-1, MAFA, and NKX6.1, as well as other maturation markers of β-cells, such as insulin, GLUT2, KIR6.2, SUR1, and VDCC. Moreover, HIP increased insulin content and promoted the ability of HFPPCs to normalize blood glucose in diabetic mice. HIP inhibited the TF FOXO1 by increasing AKT-mediated phosphorylation. HIP-induced repression of FOXO1 suppressed menin expression, leading to reducing menin binding to the promoter of the three key proislet TFs, decreasing recruitment of H3K9 methyltransferase SUV39H1, and thus reducing repressive H3K9me3 at the promoter. These coordinated actions lead to increased expression of the proislet TFs, resulting in induction of HFPPC differentiation. Consistently, constitutive activation of FOXO1 blocks HIP-induced transcription of these TFs. Together, these studies unravel the crucial role of the HIP/AKT/FOXO/menin axis in epigenetically controlling expression of proislet TFs, regulating the differentiation of HFPPCs, and normalizing blood glucose in diabetic mice.

100 Deals associated with Human proislet peptide

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Type 1	Phase 1	US	Cure DM, Inc.	01 Jul 2012
Diabetes Mellitus, Type 2	Phase 1	US	Cure DM, Inc.	01 Jul 2012

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