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Home > "S" Clinical Trials Conditions > Single Dose and 34-Day Tolerance Study of INGAP Peptide in Insulin Deficient Patients  Single Dose and 34-Day Tolerance Study of INGAP Peptide in Insulin Deficient Patients
Single Dose and 34-Day Tolerance Study of INGAP Peptide in Insulin Deficient Patients
For Condition: Diabetes Mellitus, Type 1,Diabetes Mellitus, Type 2
Status: Completed
Sponsor(s): GMP Endotherapeutics ,
Synopsis: The purpose of this study is to evaluate the safety and tolerability of single and multiple doses of intramuscular INGAP Peptide given for the first time in humans as a potential treatment for diabetes.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/70 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: Patients meeting all of the following inclusion criteria at screening can be considered for admission to the study. Stage 1 and Stage 2: 1. Male and female patients with, type 1 diabetes mellitus that are 18 through 70 years of age, or type 2 diabetes mellitus that are 30 through 70 years of age. 2. Patients who are insulin deficient and are diagnosed with type 1 or type 2 diabetes mellitus, and are currently well managed with insulin, with or without metformin. 3. Patients who have been on stable doses of insulin treatment for 90 days prior to study randomization. Exclusion Criteria: Patients meeting any of the following exclusion criteria at screening will not be enrolled in the study: 1. Patients with a history of any clinically significant retinopathy, symptomatic autonomic neuropathy, unstable angina, or kidney problems. 2. Patients with an uncontrolled or untreated significant pulmonary, neurological condition, or cardiovascular disease, including hypertension, congestive heart failure, angina, or peripheral vascular disease. 3. Patients who have received any investigational product within 30 days of admission into the study. 4. Patients with a history or clinical evidence of multiple organ autoimmune disorders. 5. Patients with a medical condition, serious intercurrent illness, or extenuating circumstance that would significantly decrease study compliance, including all prescribed follow-up. 6. Patients who are lactating and breastfeeding.
Total Enrollment: 62
Location and Contact Information:
VASDHS Medical Center
San Diego, California, 92161
United States
UNC Diabetes, Endocrinology, Metabolism Clinic
Durham, North Carolina, 27713
United States
MedStar Research Institute - Clinical Research Center
Washington D.C., District of Columbia, 20003
United States
Texas Diabetes Institute
San Antonio, Texas, 78284
United States
Additional Information:
Study ID Numbers: INGAP-01-001;
Study Start Date: December 2001
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00034255
Other Diabetes Mellitus, Type 2 Studies:
1. Safety and Efficacy of Human Insulin Inhalation Powder in Patients with Type 1 Diabetes Mellitus.
2. Islet Transplantation for patients with Type 1 diabetes
3. Single Dose and 34-Day Tolerance Study of INGAP Peptide in Insulin Deficient Patients
4. Ingested Interferon Alpha: Prolongation or Permanence of the "Honeymoon" Phase in Newly Diagnosed Type 1 Diabetes Mellitus
5. Matrix metalloproteinases and Diabetic Nephropathy
Related Studies:
Other Diabetes Mellitus, Type 2 Clinical Trials
Other North Carolina Clinical Trials
Other Durham Clinical Trials
Single Dose and 34-Day Tolerance Study of INGAP Peptide in Insulin Deficient Patients
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