An Observational Study Evaluating SYMLIN® (Pramlintide Acetate) Injection Use in Insulin Using Patients With Type 2 and Type 1 Diabetes

March 5, 2015 updated by: AstraZeneca

A Prospective, Open-Label, Observational Study Evaluating SYMLIN® (Pramlintide Acetate) Injection Use in Insulin Using Patients With Type 2 and Type 1 Diabetes Following SYMLIN Introduction Into the Marketplace

This is an open label, observational study designed to collect data that characterize the use of SYMLIN following the introduction of the medication into the marketplace. Health care providers and subjects selected for study participation are intended to be representative of those providers prescribing, and subjects receiving, SYMLIN therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1297

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • Research Site
      • Montgomery, Alabama, United States
        • Research Site
    • Arizona
      • Tucson, Arizona, United States
        • Research Site
    • California
      • Anaheim, California, United States
        • Research Site
      • Encinitas, California, United States
        • Research Site
      • Escondido, California, United States
        • Research Site
      • Fresno, California, United States
        • Research Site
      • Lafayette, California, United States
        • Research Site
      • Moreno Valley, California, United States
        • Research Site
      • Sacramento, California, United States
        • Research Site
      • Salinas, California, United States
        • Research Site
      • Santa Barbara, California, United States
        • Research Site
      • Torrance, California, United States
        • Research Site
      • Vacaville, California, United States
        • Research Site
    • Colorado
      • Arvada, Colorado, United States
        • Research Site
      • Aurora, Colorado, United States
        • Research Site
    • Connecticut
      • Norwalk, Connecticut, United States
        • Research Site
    • Delaware
      • Wilmington, Delaware, United States
        • Research Site
    • Florida
      • Hialeah, Florida, United States
        • Research Site
      • Jacksonville, Florida, United States
        • Research Site
      • Maitland, Florida, United States
        • Research Site
      • Melbourne, Florida, United States
        • Research Site
      • Miami, Florida, United States
        • Research Site
      • Plantation, Florida, United States
        • Research Site
      • Tallahassee, Florida, United States
        • Research Site
      • Winter Haven, Florida, United States
        • Research Site
    • Georgia
      • Canton, Georgia, United States
        • Research Site
      • Columbus, Georgia, United States
        • Research Site
      • Roswell, Georgia, United States
        • Research Site
      • Valdosta, Georgia, United States
        • Research Site
    • Hawaii
      • Aiea, Hawaii, United States
        • Research Site
    • Idaho
      • Caldwell, Idaho, United States
        • Research Site
      • Idaho Falls, Idaho, United States
        • Research Site
      • Pocatello, Idaho, United States
        • Research Site
    • Illinois
      • Evergreen Park, Illinois, United States
        • Research Site
      • Wheaton, Illinois, United States
        • Research Site
    • Indiana
      • Fort Wayne, Indiana, United States
        • Research Site
      • Franklin, Indiana, United States
        • Research Site
      • Indianapolis, Indiana, United States
        • Research Site
    • Iowa
      • Des Moines, Iowa, United States
        • Research Site
    • Kansas
      • Shawnee Mission, Kansas, United States
        • Research Site
      • Wichita, Kansas, United States
        • Research Site
    • Kentucky
      • Louisville, Kentucky, United States
        • Research Site
    • Louisiana
      • Baton Rouge, Louisiana, United States
        • Research Site
      • Lafayette, Louisiana, United States
        • Research Site
      • Laplace, Louisiana, United States
        • Research Site
    • Maryland
      • Glen Burnie, Maryland, United States
        • Research Site
      • Towson, Maryland, United States
        • Research Site
    • Michigan
      • Ann Arbor, Michigan, United States
        • Research Site
      • Bloomfield, Michigan, United States
        • Research Site
      • Detroit, Michigan, United States
        • Research Site
      • Grand Rapids, Michigan, United States
        • Research Site
    • Minnesota
      • Duluth, Minnesota, United States
        • Research Site
      • Eagan, Minnesota, United States
        • Research Site
    • Montana
      • Butte, Montana, United States
        • Research Site
    • Nevada
      • Las Vegas, Nevada, United States
        • Research Site
      • Reno, Nevada, United States
        • Research Site
    • New Jersey
      • Hamilton, New Jersey, United States
        • Research Site
      • Jersey City, New Jersey, United States
        • Research Site
      • Livingston, New Jersey, United States
        • Research Site
      • Moorestown, New Jersey, United States
        • Research Site
      • Neptune, New Jersey, United States
        • Research Site
      • North Plainfield, New Jersey, United States
        • Research Site
    • New York
      • Albany, New York, United States
        • Research Site
      • Binghamton, New York, United States
        • Research Site
      • Forest Hills, New York, United States
        • Research Site
      • Lawrence, New York, United States
        • Research Site
      • New York, New York, United States
        • Research Site
      • Riverhead, New York, United States
        • Research Site
      • Rochester, New York, United States
        • Research Site
      • Staten Island, New York, United States
        • Research Site
      • Utica, New York, United States
        • Research Site
    • North Carolina
      • Greensboro, North Carolina, United States
        • Research Site
      • Morehead City, North Carolina, United States
        • Research Site
      • Raleigh, North Carolina, United States
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States
        • Research Site
      • Columbus, Ohio, United States
        • Research Site
      • Mentor, Ohio, United States
        • Research Site
      • Toledo, Ohio, United States
        • Research Site
    • Oregon
      • Portland, Oregon, United States
        • Research Site
      • Salem, Oregon, United States
        • Research Site
    • Pennsylvania
      • Bridgeville, Pennsylvania, United States
        • Research Site
      • Carlisle, Pennsylvania, United States
        • Research Site
      • Erie, Pennsylvania, United States
        • Research Site
      • Sewickley, Pennsylvania, United States
        • Research Site
    • South Carolina
      • Columbia, South Carolina, United States
        • Research Site
      • Orangeburg, South Carolina, United States
        • Research Site
      • Sumter, South Carolina, United States
        • Research Site
    • Tennessee
      • Chattanooga, Tennessee, United States
        • Research Site
      • Hendersonville, Tennessee, United States
        • Research Site
      • Hixon, Tennessee, United States
        • Research Site
      • Memphis, Tennessee, United States
        • Research Site
      • Nashville, Tennessee, United States
        • Research Site
    • Texas
      • Austin, Texas, United States
        • Research Site
      • Beaumont, Texas, United States
        • Research Site
      • Houston, Texas, United States
        • Research Site
      • San Antonio, Texas, United States
        • Research Site
    • Utah
      • Provo, Utah, United States
        • Research Site
      • Salt Lake City, Utah, United States
        • Research Site
    • Virginia
      • McLean, Virginia, United States
        • Research Site
      • Norton, Virginia, United States
        • Research Site
    • Washington
      • Puyallup, Washington, United States
        • Research Site
      • Seattle, Washington, United States
        • Research Site
      • Spokane, Washington, United States
        • Research Site
      • Tacoma, Washington, United States
        • Research Site
      • Walla Walla, Washington, United States
        • Research Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

cross-section of clinical practice settings

Description

Inclusion Criteria:

  • The following inclusion criteria are consistent with information in the SYMLIN package insert and apply to insulin using patients with type 2 or type 1 diabetes who:

    • Have failed to achieve the desired or optimal level of glycemic control despite utilizing appropriate, individualized insulin regimens
    • Have A1C <=9.0% within 3 months of study enrollment
    • Are receiving ongoing diabetes care under the guidance of a Health Care Provider (HCP) trained in the use of SYMLIN

Exclusion Criteria:

  • The following exclusion criteria are consistent with the SYMLIN package insert and specifically exclude patients who:

    • Are poorly compliant with their current insulin regimen, as defined by their HCP
    • Are poorly compliant with prescribed blood glucose self monitoring, as defined by their HCP
    • Have experienced recurrent patient-ascertained severe hypoglycemia requiring assistance during the past 6 months
    • Have hypoglycemia unawareness
    • Have a confirmed diagnosis of gastroparesis
    • Require the use of drugs that stimulate gastrointestinal motility
    • Are female and pregnant or lactating and for whom the HCP determines the potential benefit does not justify the potential risk to the fetus or infant
    • Have been treated with SYMLIN within 3 months prior to study start

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Type 1
Patients with type 1 diabetes
Drug: pramlintide acetate
Subcutaneous injection prior to each major meal
Other Names:
  • Symlin
Type 2
Patients with type 2 diabetes
Drug: pramlintide acetate
Subcutaneous injection prior to each major meal
Other Names:
  • Symlin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Patient-Ascertained Severe Hypoglycemia (PASH) During the Adjustment Period
Time Frame: 0-3 months
PASH is defined as episodes of hypoglycemia requiring the assistance of another individual (including aid in ingestion of oral carbohydrate); and/or requiring the administration of glucagon injection, intravenous glucose, or other medical intervention. The adjustment period represents the initial 0-3 months of pramlintide treatment
0-3 months
Annual Event Rate of Patient-Ascertained Severe Hypoglycemia (PASH) During the Adjustment Period
Time Frame: 0-3 months

The annual event rate was calculated as the total number of events during the time period divided by the total years of exposure to pramlintide for all patients during the time period. The adjustment period represents the initial 0-3 months of pramlintide treatment.

PASH is defined as episodes of hypoglycemia requiring the assistance of another individual (including aid in ingestion of oral carbohydrate); and/or requiring the administration of glucagon injection, intravenous glucose, or other medical intervention.
0-3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Incidence of Patient-Ascertained Severe Hypoglycemia (PASH) During the Steady State Period
Time Frame: >3-6 months

The steady state period represents the >3-6 months of pramlintide treatment following the adjustment period.

PASH is defined as episodes of hypoglycemia requiring the assistance of another individual (including aid in ingestion of oral carbohydrate); and/or requiring the administration of glucagon injection, intravenous glucose, or other medical intervention.
>3-6 months
The Annual Event Rate of Patient-Ascertained Severe Hypoglycemia (PASH) During the Steady State Period
Time Frame: >3-6 months

The annual event rate was calculated as the total number of events during the time period divided by the total years of exposure to pramlintide for all patients during the time period. The steady state period represents the >3-6 months of pramlintide treatment following the adjustment period.

PASH is defined as episodes of hypoglycemia requiring the assistance of another individual (including aid in ingestion of oral carbohydrate); and/or requiring the administration of glucagon injection, intravenous glucose, or other medical intervention.
>3-6 months
Incidence of Medically Assisted Severe Hypoglycemia (MASH) During the Adjustment Period
Time Frame: 0-3 months
MASH is defined as episodes of severe hypoglycemia requiring IM glucagon, IV glucose, hospitalization, paramedic assistance, emergency room visit, and/or is assessed as a serious adverse event (SAE) by the investigator. MASH is a subset of PASH. The adjustment period represents the initial 0-3 months of pramlintide treatment
0-3 months
The Annual Event Rate of Medically Assisted Severe Hypoglycemia (MASH) During the Adjustment Period
Time Frame: 0-3 months

The annual event rate was calculated as the total number of events during the time period divided by the total years of exposure to pramlintide for all patients during the time period. The adjustment period represents the initial 0-3 months of pramlintide treatment.

MASH is defined as episodes of severe hypoglycemia requiring IM glucagon, IV glucose, hospitalization, paramedic assistance, emergency room visit, and/or is assessed as a serious adverse event (SAE) by the investigator. MASH is a subset of PASH.
0-3 months
Incidence of Medically Assisted Severe Hypoglycemia (MASH) During the Steady State Period
Time Frame: >3-6 months

The steady state period represents the >3-6 months of pramlintide treatment following the adjustment period.

MASH is defined as episodes of severe hypoglycemia requiring IM glucagon, IV glucose, hospitalization, paramedic assistance, emergency room visit, and/or is assessed as a serious adverse event (SAE) by the investigator. MASH is a subset of PASH.
>3-6 months
Annual Event Rate of Medically Assisted Severe Hypoglycemia (MASH) During the Steady State Period
Time Frame: >3-6 months

The annual event rate was calculated as the total number of events during the time period divided by the total years of exposure to pramlintide for all patients during the time period. The steady state period represents the >3-6 months of pramlintide treatment following the adjustment period.

MASH is defined as episodes of severe hypoglycemia requiring IM glucagon, IV glucose, hospitalization, paramedic assistance, emergency room visit, and/or is assessed as a serious adverse event (SAE) by the investigator. MASH is a subset of PASH.
>3-6 months
Change in HbA1c From Baseline at Month 3
Time Frame: 3 months
Change in HbA1c from baseline at month 3. The HbA1c test measures the percent of glycosylated hemoglobin in the blood.
3 months
Change in HbA1c From Baseline at Month 6
Time Frame: 6 months
Change in HbA1c from baseline at month 6. The HbA1c test measures the percent of glycosylated hemoglobin in the blood.
6 months
Change in Body Weight From Baseline at Month 3
Time Frame: 3 months
Mean change in body weight from baseline at month 3
3 months
Change in Body Weight From Baseline at Month 6
Time Frame: 6 months
Mean change in body weight from baseline at month 6
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Vice President, Medical Development, MD, Amylin Pharmaceuticals, LLC.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

September 28, 2005

First Submitted That Met QC Criteria

September 28, 2005

First Posted (Estimate)

September 30, 2005

Study Record Updates

Last Update Posted (Estimate)

March 25, 2015

Last Update Submitted That Met QC Criteria

March 5, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 137-161

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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