Safety and Efficacy of INGAP-Peptide in Patients With Type 2 Diabetes

Insulin is a chemical that the body needs in order to use or store sugar. It is made by a type of cell called a beta cell which resides in an organ known as the pancreas. Type 2 diabetes is a disease where the beta cells are unable to meet a person's insulin needs. Sugar levels rise in the blood as a result. INGAP-Peptide is being tested to attempt to create new beta cells in the pancreas, and to improve the ability to produce insulin in type 2 diabetic patients.

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Key information

Conditions

Diabetes Mellitus, Non-Insulin-Dependent Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

35 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Diabetes and Endocrine Associates, La Jolla, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age 35-70
Using >20 Units of insulin per day
HbA1c from 6.5% to 10%
No islet antibodies
Otherwise healthy

Treatment and study plan

INGAP-Peptide

Drug

1.5 mL, once daily, self-administered SC injection for 90 days

Placebo

Drug

1.5 mL, once daily, self-administered SC injection for 90 days

Sponsors and collaborators

Lead sponsor

Exsulin Corporation

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled, Rising-dose, Multicenter Study to Evaluate the Efficacy and Safety of 90 Days of 300 or 600 mg Daily Subcutaneous Injections of INGAP Peptide in Insulin-using Type 2 Diabetes Mellitus Patients

Important dates

Study start: 2003
Primary completion: 2004
Study completion: 2004
First posted: Oct 23, 2003
Registry last updated: Jul 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed