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

Primary Purpose

IDDM

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Continuous Pramlintide infusion
Sponsored by
University Diabetes & Endocrine Consultants
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for IDDM focused on measuring diabetes, insulin, pramlintide, IDDM

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Diabetes & Endocrine Consultants

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A

Arm Description

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

Outcomes

Primary Outcome Measures

Fasting and postprandial pramlintide pharmacokinetics

Secondary Outcome Measures

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

Full Information

First Posted
July 16, 2007
Last Updated
January 15, 2013
Sponsor
University Diabetes & Endocrine Consultants
Collaborators
Amylin Pharmaceuticals, LLC.
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1. Study Identification

Unique Protocol Identification Number
NCT00502138
Brief Title
A Pilot Study of Continuous Subcutaneous Pramlintide Infusion Therapy in Patients With Type 1 Diabetes
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Diabetes & Endocrine Consultants
Collaborators
Amylin Pharmaceuticals, LLC.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IDDM
Keywords
diabetes, insulin, pramlintide, IDDM

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Interventional, continuous pramlintide infusion at 9 micrograms/hr plus 60 microgram meal bolus plus continuous insulin basal-bolus subcutaneous infusion
Intervention Type
Drug
Intervention Name(s)
Continuous Pramlintide infusion
Other Intervention Name(s)
pramlintide
Intervention Description
pramlintide injection, 9 mcg/hr plus 60 mcg premeal boluses
Primary Outcome Measure Information:
Title
Fasting and postprandial pramlintide pharmacokinetics
Time Frame
Four months
Secondary Outcome Measure Information:
Title
Hemoglobin A1c, body weight, blood glucose variability, patient satisfaction
Time Frame
four months
Title
Hemoglobin A1c
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Type 1 diabetes of at least one year duration; Treated with CSII therapy for at least 6 months; Age 18 to 70 years, inclusive; A1C >7.0 and ≤10% as screening; BMI ≤35 kg/m2; Stable insulin dose (±10%) for at least 3 months prior to screening; If female, has a negative urine pregnancy test at screening; 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; Able to understand and sign the required study documents and comply with the protocol requirements Exclusion Criteria: Is poorly compliant with the currently prescribed insulin regimen, as determined by the investigator; Has any significant medical condition, laboratory findings, or medical history that may affect successful completion of the study and/or personal well-being; If female and if of childbearing potential, is pregnant, lactating, or planning to become pregnant; Has experienced recurrent severe hypoglycemia requiring assistance during the past 6 months; Has a history of hypoglycemia unawareness; Has a confirmed diagnosis of gastroparesis; Requires the use of drugs that stimulate gastrointestinal motility; Is receiving medications known to interfere with glycemic control (i.e. glucocorticoids); Has been treated with any oral antidiabetic agent or exenatide within 3 months of screening visit; Has been treated with pramlintide within 3 months of screening visit; Has received an investigational drug within 3 month of screening visit; Is currently participating in a clinical trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David M Huffman, MD
Organizational Affiliation
University Diabetes & Endocrine Consultants
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Diabetes & Endocrine Consultants
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19546056
Citation
Huffman DM, McLean GW, Seagrove MA. Continuous subcutaneous pramlintide infusion therapy in patients with type 1 diabetes: observations from a pilot study. Endocr Pract. 2009 Nov-Dec;15(7):689-95. doi: 10.4158/EP09044.ORR1.
Results Reference
derived

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

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