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

Phase 2
Completed
Conditions
Diabetes Mellitus, Non-Insulin-Dependent
Interventions
Drug: INGAP-Peptide
Drug: placebo
Registration Number
NCT00071422
Lead Sponsor
Exsulin Corporation
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
126
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
600 mg INGAP PeptideINGAP-Peptide1.5 mL SC injection, once daily for 90 days
placeboplacebo1.5 mL SC injection, once daily for 90 days
300 mg INGAP PeptideINGAP-Peptide1.5 mL SC injection, once daily for 90 days
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (16)

VA Hospital UCSD

🇺🇸

San Diego, California, United States

Diabetes and Endocrine Associates

🇺🇸

La Jolla, California, United States

Diablo Clinical Research

🇺🇸

Walnut Creek, California, United States

Longmont Medical Research Network

🇺🇸

Longmont, Colorado, United States

MedStar Clinical Research Center

🇺🇸

Washington, District of Columbia, United States

Future Care Studies

🇺🇸

Springfield, Massachusetts, United States

Diabetes-Endocrinology Center of WNY

🇺🇸

Buffalo, New York, United States

UNC Diabetes Care Center

🇺🇸

Durham, North Carolina, United States

Piedmont Medical Group

🇺🇸

Winston-Salem, North Carolina, United States

Clinical Research Institute of Southern Oregon

🇺🇸

Medford, Oregon, United States

Mountain View Clinical Research

🇺🇸

Greer, South Carolina, United States

Dallas Diabetes and Endocrine Center

🇺🇸

Dallas, Texas, United States

University of Texas Health Science Center - Texas Diabetes Institute

🇺🇸

San Antonio, Texas, United States

DGD Research Associates

🇺🇸

San Antonio, Texas, United States

Charlottesville Medical Research

🇺🇸

Charlottesville, Virginia, United States

Mercury Street Medical

🇺🇸

Butte, Montana, United States

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