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Trial · Interventional

CompletedPhase 4Registry data

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

NCTNCT00502138 (opens ClinicalTrials.gov in a new tab)Other idPramlintide Infusion in IDDM
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
12 participants (actual)
Sponsor
University Diabetes & Endocrine Consultants · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
Jul 2007
Primary completion
Jan 2008
Completion
Jan 2008
First posted
17 Jul 2007 (estimated)
Last update posted
16 Jan 2013 (estimated)
Conditions
IDDM

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200720082009
  1. Ph 4

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

    NCT00502138

    Jul 2007 to Jan 2008

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Continuous Pramlintide infusionDrug

Arms1

  • Experimental

    A

    Interventional, continuous pramlintide infusion at 9 micrograms/hr plus 60 microgram meal bolus plus continuous insulin basal-bolus subcutaneous infusion

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Fasting and postprandial pramlintide pharmacokinetics

    Time frame · Four months

Secondary outcomes(2)

  1. Hemoglobin A1c, body weight, blood glucose variability, patient satisfaction

    Time frame · four months

  2. Hemoglobin A1c

    Time frame · 16 weeks

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Clinical trial · 2009

9 results

Continuous subcutaneous pramlintide infusion therapy in patients with type 1 diabetes: observations from a pilot study.

Huffman et al. 2009Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologistscited by 18

PMID 19546056DOI 10.4158/ep09044.orr1PUB-19546056

Full text at the publisher9 results
Publisher pageSee results (9)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 70 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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