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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
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.
Age
35 - 70 years
Sex
ALL
Healthy Volunteers
No
Diabetes and Endocrine Associates
La Jolla, California, United States
VA Hospital UCSD
San Diego, California, United States
Diablo Clinical Research
Walnut Creek, California, United States
Denver, Colorado, United States
Longmont Medical Research Network
Longmont, Colorado, United States
MedStar Clinical Research Center
Washington D.C., District of Columbia, United States
Future Care Studies
Springfield, Massachusetts, United States
Mercury Street Medical
Butte, Montana, United States
Diabetes-Endocrinology Center of WNY
Buffalo, New York, United States
UNC Diabetes Care Center
Durham, North Carolina, United States
Start Date
October 1, 2003
Primary Completion Date
June 1, 2004
Completion Date
June 1, 2004
Last Updated
July 11, 2014
126
ACTUAL participants
INGAP-Peptide
DRUG
INGAP-Peptide
DRUG
placebo
DRUG
Lead Sponsor
Exsulin Corporation
NCT02088658
NCT02113163
Data Source & Attribution
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