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| Sponsor: | Procter and Gamble |
|---|---|
| Information provided by: | Procter and Gamble |
| ClinicalTrials.gov Identifier: | NCT00071409 |
Purpose
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 1 diabetes is a disease where the beta cells have been destroyed so that little or no insulin is made. 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 restore the ability to produce insulin in type 1 diabetic patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Insulin-Dependent |
Drug: INGAP-Peptide Drug: placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official 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 Type I Diabetes Mellitus Patients |
| Enrollment: | 63 |
| Study Start Date: | October 2003 |
| Study Completion Date: | May 2004 |
| Primary Completion Date: | May 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
placebo: Placebo Comparator
1.5 mL SC injection
|
Drug: placebo
1.5 mL, once daily, self-administered SC injection for 90 days
|
|
300 mg INGAP Peptide: Experimental
1.5 mL SC injection, once daily for 90 days
|
Drug: INGAP-Peptide
1.5 mL, once daily, self-administered SC injection for 90 days
|
|
600 mg INGAP Peptide: Experimental
1.5 mL SC injection, once daily for 90 days
|
Drug: INGAP-Peptide
1.5 mL, once daily, self-administered SC injection for 90 days
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Contacts and Locations| United States, California | |
| Radiant Research | |
| Irvine, California, United States, 92618 | |
| Diablo Clinical Research | |
| Walnut Creek, California, United States, 94598 | |
| VA Hospital UCSD | |
| San Diego, California, United States, 92161 | |
| United States, District of Columbia | |
| MedStar Clinical Research Center | |
| Washington, District of Columbia, United States, 20003 | |
| United States, Illinois | |
| Springfield Diabetes and Endocrine Center | |
| Springfield, Illinois, United States, 62704 | |
| United States, Montana | |
| Mercury Street Medical | |
| Butte, Montana, United States, 59701 | |
| United States, North Carolina | |
| UNC Diabetes Care Center | |
| Durham, North Carolina, United States, 27713 | |
| United States, Oregon | |
| Clinical Research Institute of Southern Oregon | |
| Medford, Oregon, United States, 97504 | |
| United States, Texas | |
| DGD Research Associates | |
| San Antonio, Texas, United States, 78229 | |
| University of Texas Health Science Center - Texas Diabetes Institute | |
| San Antonio, Texas, United States, 78207 | |
More Information
| Responsible Party: | Procter and Gamble Pharmaceuticals ( Muhammad Rehman, MD ) |
| Study ID Numbers: | 2003068 |
| Study First Received: | October 22, 2003 |
| Last Updated: | July 22, 2009 |
| ClinicalTrials.gov Identifier: | NCT00071409 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Type 1 diabetes |
|
Autoimmune Diseases Metabolic Diseases Immune System Diseases Diabetes Mellitus, Type 1 |
Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders |
