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A Pilot Study of Continuous Subcutaneous Pramlintide Infusion Therapy in Patients With Type 1 Diabetes

This study has been completed.
Sponsor:
Collaborator:
Amylin Pharmaceuticals, LLC.
Information provided by (Responsible Party):
David M. Huffman MD, University Diabetes & Endocrine Consultants
ClinicalTrials.gov Identifier:
NCT00502138
First received: July 16, 2007
Last updated: January 15, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
IDDM
 Drug: Continuous Pramlintide infusion
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study to Assess the Pharmacokinetics, Pharmacodynamics and Safety/Tolerability of Pramlintide Acetate When Administered by Subcutaneous Infusion in a Basal-Bolus Manner as an Adjunct to Continuous Subcutaneous Insulin Infusion Therapy in Patients With Type 1 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Diabetes & Endocrine Consultants:

Primary Outcome Measures:
  • Fasting and postprandial pramlintide pharmacokinetics [ Time Frame: Four months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hemoglobin A1c, body weight, blood glucose variability, patient satisfaction [ Time Frame: four months ] [ Designated as safety issue: Yes ]
  • Hemoglobin A1c [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: July 2007
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Interventional, continuous pramlintide infusion at 9 micrograms/hr plus 60 microgram meal bolus plus continuous insulin basal-bolus subcutaneous infusion
 Drug: Continuous Pramlintide infusion
pramlintide injection, 9 mcg/hr plus 60 mcg premeal boluses
Other Name: pramlintide

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00502138

Locations
United States, Tennessee
University Diabetes & Endocrine Consultants
Chattanooga, Tennessee, United States, 37403
Sponsors and Collaborators
University Diabetes & Endocrine Consultants
Amylin Pharmaceuticals, LLC.
Investigators
Principal Investigator: David M Huffman, MD University Diabetes & Endocrine Consultants
  More Information

No publications provided by University Diabetes & Endocrine Consultants

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: David M. Huffman MD, Principal Investigator, University Diabetes & Endocrine Consultants
ClinicalTrials.gov Identifier: NCT00502138     History of Changes
Other Study ID Numbers: Pramlintide Infusion in IDDM
Study First Received: July 16, 2007
Last Updated: January 15, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University Diabetes & Endocrine Consultants:
diabetes
insulin
pramlintide
IDDM

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Pramlintide
 Islet Amyloid Polypeptide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Appetite Depressants
Anti-Obesity Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013