Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Conditions
Brief summary
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.
Interventions
DRUGINGAP Peptide
Sponsors
GMP Endotherapeutics
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Countries
United States
Outcome results
None listed