NCT00502138

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2007

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

July 16, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 17, 2007

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

January 16, 2013

Status Verified

January 1, 2013

Enrollment Period

6 months

First QC Date

July 16, 2007

Last Update Submit

January 15, 2013

Conditions

IDDM

Keywords

diabetesinsulinpramlintideIDDM

Outcome Measures

Primary Outcomes (1)

  • Fasting and postprandial pramlintide pharmacokinetics

    Four months

Secondary Outcomes (2)

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

    four months

  • Hemoglobin A1c

    16 weeks

Study Arms (1)

A

EXPERIMENTAL

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

Drug: Continuous Pramlintide infusion

Interventions

Continuous Pramlintide infusionDRUG

pramlintide injection, 9 mcg/hr plus 60 mcg premeal boluses

Also known as: pramlintide
A

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Diabetes & Endocrine Consultants

Chattanooga, Tennessee, 37403, United States

Location

Related Publications (1)

  • 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.

    PMID: 19546056DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes MellitusInsulin Resistance

Interventions

pramlintide

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesHyperinsulinism

Study Officials

  • David M Huffman, MD

    University Diabetes & Endocrine Consultants

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 16, 2007

First Posted

July 17, 2007

Study Start

July 1, 2007

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

January 16, 2013

Record last verified: 2013-01

Locations

US(1)