IDDM
Conditions
Keywords
diabetes, insulin, pramlintide, IDDM
Brief summary
This research project will investigate the effects of pramlintide (Symlin) given by continuous subcutaneous (under the skin) infusion throughout the day and night, along with meal doses similar to those injected during conventional pramlintide (Symlin) treatment, delivered using a second insulin pump, in subjects with inadequately controlled type I diabetes mellitus who are already using insulin pump therapy. Study participants will wear two pumps for a four month period, taking insulin in their usual manner and pramlintide (Symlin) in a similar basal/bolus fashion. Continuous glucose monitors will be worn on three occasions during the study to assess blood glucose responses to continuous pramlintide (Symlin) treatment.
Detailed description
DESCRIPTION OF STUDY: To participate in the study, you must have Type I diabetes mellitus and be taking insulin using an insulin pump, and have a hemoglobin A1c level between 7.0% and 10.0%. You will not be permitted to participate in the study if you have taken pramlintide (Symlin) during the previous three months. The study will consist of seven visits to the Study Center over a four-month period. Subjects will undergo meal tolerance testing at beginning and end of study period. Continuous blood glucose monitoring will be performed on three occasions during the study. Pramlintide will be begun at a single basal rate of 1.5 units/hr. Bolus therapy will be begun thereafter per standard manufacturer protocol. Subjects will be monitored for three months on basal-bolus pramlintide therapy.
Interventions
DRUGContinuous Pramlintide infusion
pramlintide injection, 9 mcg/hr plus 60 mcg premeal boluses
Sponsors
Amylin Pharmaceuticals, LLC.
University Diabetes & Endocrine Consultants
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Type 1 diabetes of at least one year duration; 2. Treated with CSII therapy for at least 6 months; 3. Age 18 to 70 years, inclusive; 4. A1C \>7.0 and ≤10% as screening; 5. BMI ≤35 kg/m2; 6. Stable insulin dose (±10%) for at least 3 months prior to screening; 7. If female, has a negative urine pregnancy test at screening; 8. If female and of childbearing potential, practicing and willing to continue to using appropriate contraception to ensure that pregnancy does not occur during the study; 9. Able to understand and sign the required study documents and comply with the protocol requirements
Exclusion criteria
1. Is poorly compliant with the currently prescribed insulin regimen, as determined by the investigator; 2. Has any significant medical condition, laboratory findings, or medical history that may affect successful completion of the study and/or personal well-being; 3. If female and if of childbearing potential, is pregnant, lactating, or planning to become pregnant; 4. Has experienced recurrent severe hypoglycemia requiring assistance during the past 6 months; 5. Has a history of hypoglycemia unawareness; 6. Has a confirmed diagnosis of gastroparesis; 7. Requires the use of drugs that stimulate gastrointestinal motility; 8. Is receiving medications known to interfere with glycemic control (i.e. glucocorticoids); 9. Has been treated with any oral antidiabetic agent or exenatide within 3 months of screening visit; 10. Has been treated with pramlintide within 3 months of screening visit; 11. Has received an investigational drug within 3 month of screening visit; 12. Is currently participating in a clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fasting and postprandial pramlintide pharmacokinetics | Four months |
Secondary
| Measure | Time frame |
|---|---|
| Hemoglobin A1c, body weight, blood glucose variability, patient satisfaction | four months |
| Hemoglobin A1c | 16 weeks |
Countries
United States
Outcome results
None listed