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Tolerability, Safety, and Efficacy Study of INGAP Peptide to Treat Type 1 Diabetes Mellitus in Adults

2014-08-27 03:18:40 | BioPortfolio

Summary

INGAP Peptide acetate is the active ingredient of INGAP Peptide Solution for Injection. It is being developed as an antidiabetic agent for the restoration of endogenous insulin secretion in patients with type 1 diabetes mellitus (T1DM) and in insulin-deficient patients with type 2 diabetes mellitus (T2DM). This clinical study is designed to generate additional data regarding the appropriate dose and dosing regimen and to evaluate safety and efficacy in patients with T1DM.

Description

In contrast to currently approved therapies that are directed at controlling either the metabolic abnormalities or tissue complications of diabetes, INGAP Peptide therapy is intended to restore ß cell mass and islet cell function. INGAP Peptide has been identified as a substance that induces islet cell regeneration from progenitor cells resident in the pancreas in a manner that recapitulates islet development during normal embryogenesis.

INGAP Peptide therapy has been evaluated in phase 1 and 2 studies of both T1DM and T2DM patients (Dungan K, Diab Met Res Rev 2009; 25:558-565). Once daily injections of INGAP Peptide for 3 months caused a statistically significant increase in C peptide secretion in T1DM patients, and a trend towards increased C-peptide levels was seen in T2DM patients. Glycosylated hemoglobin (HbA1c) decreased by -0.6% (p<0.0125) in T2DM patients and by -0.4% (p<0.06) in T1DM patients.

Given the very short half-life or INGAP Peptide (i.e., <1 hour), the findings of these earlier phase 2 studies in patients with T1DM and T2DM are very encouraging in that despite suboptimal exposure to the drug, there was evidence of efficacy. Local injection site reactions observed in those studies may have been due to relatively large doses of formulations that were not optimized for tonicity and patient comfort.

This study has been designed such that the dose of INGAP Peptide will be divided across three daily administrations using a formulation that has been improved with respect to tonicity. The study will evaluate the safety, tolerability and C-peptide response associated with this dosing regimen in patients with T1DM.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Conditions

Type 1 Diabetes Mellitus

Intervention

INGAP Peptide, INGAP Peptide, Placebo

Location

Mayo Clinic
Rochester
Minnesota
United States
55905

Status

Recruiting

Source

Exsulin Corporation

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:18:40-0400

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Medical and Biotech [MESH] Definitions

An analog of GLUCAGON-LIKE PEPTIDE 1 and agonist of the GLUCAGON-LIKE PEPTIDE 1 RECEPTOR that is used as a HYPOGLYCEMIC AGENT and supplemental therapy in the treatment of DIABETES MELLITUS by patients who do not respond to METFORMIN.

A subclass of DIABETES MELLITUS that is not INSULIN-responsive or dependent (NIDDM). It is characterized initially by INSULIN RESISTANCE and HYPERINSULINEMIA; and eventually by GLUCOSE INTOLERANCE; HYPERGLYCEMIA; and overt diabetes. Type II diabetes mellitus is no longer considered a disease exclusively found in adults. Patients seldom develop KETOSIS but often exhibit OBESITY.

The time period before the development of symptomatic diabetes. For example, certain risk factors can be observed in subjects who subsequently develop INSULIN RESISTANCE as in type 2 diabetes (DIABETES MELLITUS, TYPE 2).

The production of PEPTIDES or PROTEINS by the constituents of a living organism. The biosynthesis of proteins on RIBOSOMES following an RNA template is termed translation (TRANSLATION, GENETIC). There are other, non-ribosomal peptide biosynthesis (PEPTIDE BIOSYNTHESIS, NUCLEIC ACID-INDEPENDENT) mechanisms carried out by PEPTIDE SYNTHASES and PEPTIDYLTRANSFERASES. Further modifications of peptide chains yield functional peptide and protein molecules.

A pituitary adenylate cyclase-activating peptide receptor subtype found in LYMPHOCYTES. It binds both PACAP and VASOACTIVE INTESTINAL PEPTIDE and regulates immune responses.

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