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Completed Phase 1 Interventional Accepts healthy volunteers

A Study of Subcutaneous Doses of HIP2B in Healthy Male Subjects

ClinicalTrials.gov ID: NCT01638611

Public ClinicalTrials.gov record NCT01638611. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 4, 2026, 2:20 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01638611
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
CureDM
Industry
Enrollment
40 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
19 Years to 45 Years
Sex
Male
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 30, 2012
Primary completion
Aug 31, 2012
Completion
Aug 31, 2012
Last update posted
Nov 14, 2016

2012

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Celerion Lincoln Nebraska 68502

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01638611, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 14, 2016 · Synced Sep 4, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01638611 live on ClinicalTrials.gov.

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