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

NCT00229658 | Completed Results

• 1 other identifier: 137-161
• Study Type: observational
• Target: 1,297
• Locations: 1 country
• Sites: 107

Brief Summary

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.

Conditions

Type 1 Diabetes Mellitus; Type 2 Diabetes Mellitus

Keywords

diabetes; pramlintide; Symlin; Amylin; phase 4

Outcome Measures

Primary Outcomes (2)

• Incidence of Patient-Ascertained Severe Hypoglycemia (PASH) During 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. 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

  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 Outcomes (10)

• The Incidence of Patient-Ascertained Severe Hypoglycemia (PASH) During the Steady State Period

  >3-6 months

• The Annual Event Rate of Patient-Ascertained Severe Hypoglycemia (PASH) During the Steady State Period

  >3-6 months

• Incidence of Medically Assisted Severe Hypoglycemia (MASH) During the Adjustment Period

  0-3 months

• The Annual Event Rate of Medically Assisted Severe Hypoglycemia (MASH) During the Adjustment Period

  0-3 months

• Incidence of Medically Assisted Severe Hypoglycemia (MASH) During the Steady State Period

  >3-6 months

Study Arms (2)

Type 1

Patients with type 1 diabetes

Drug: pramlintide acetate

Type 2

Patients with type 2 diabetes

Drug: pramlintide acetate

Interventions

pramlintide acetate DRUG

Subcutaneous injection prior to each major meal

Also known as: Symlin

Type 1; Type 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

cross-section of clinical practice settings

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (107)

Research Site

Birmingham, Alabama, United States

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Montgomery, Alabama, United States

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Tucson, Arizona, United States

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Anaheim, California, United States

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Encinitas, California, United States

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Escondido, California, United States

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Fresno, California, United States

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Lafayette, California, United States

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Moreno Valley, California, United States

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Sacramento, California, United States

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Salinas, California, United States

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Santa Barbara, California, United States

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Torrance, California, United States

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Vacaville, California, United States

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Arvada, Colorado, United States

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Aurora, Colorado, United States

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Norwalk, Connecticut, United States

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Wilmington, Delaware, United States

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Hialeah, Florida, United States

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Jacksonville, Florida, United States

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Maitland, Florida, United States

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Melbourne, Florida, United States

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Miami, Florida, United States

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Plantation, Florida, United States

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Tallahassee, Florida, United States

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Winter Haven, Florida, United States

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Canton, Georgia, United States

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Columbus, Georgia, United States

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Roswell, Georgia, United States

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Valdosta, Georgia, United States

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‘Aiea, Hawaii, United States

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Caldwell, Idaho, United States

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Idaho Falls, Idaho, United States

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Pocatello, Idaho, United States

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Evergreen Park, Illinois, United States

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Wheaton, Illinois, United States

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Fort Wayne, Indiana, United States

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Franklin, Indiana, United States

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Indianapolis, Indiana, United States

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Des Moines, Iowa, United States

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Shawnee Mission, Kansas, United States

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Wichita, Kansas, United States

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Louisville, Kentucky, United States

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Baton Rouge, Louisiana, United States

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Lafayette, Louisiana, United States

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Laplace, Louisiana, United States

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Glen Burnie, Maryland, United States

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Towson, Maryland, United States

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Ann Arbor, Michigan, United States

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Bloomfield, Michigan, United States

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Detroit, Michigan, United States

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Grand Rapids, Michigan, United States

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Duluth, Minnesota, United States

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Eagan, Minnesota, United States

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Butte, Montana, United States

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Las Vegas, Nevada, United States

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Reno, Nevada, United States

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Hamilton, New Jersey, United States

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Jersey City, New Jersey, United States

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Livingston, New Jersey, United States

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Moorestown, New Jersey, United States

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Neptune City, New Jersey, United States

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North Plainfield, New Jersey, United States

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Albany, New York, United States

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Binghamton, New York, United States

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Forest Hills, New York, United States

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Lawrence, New York, United States

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New York, New York, United States

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Riverhead, New York, United States

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Rochester, New York, United States

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Staten Island, New York, United States

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Utica, New York, United States

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Greensboro, North Carolina, United States

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Morehead City, North Carolina, United States

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Raleigh, North Carolina, United States

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Cincinnati, Ohio, United States

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Columbus, Ohio, United States

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Mentor, Ohio, United States

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Toledo, Ohio, United States

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Portland, Oregon, United States

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Salem, Oregon, United States

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Bridgeville, Pennsylvania, United States

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Carlisle, Pennsylvania, United States

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Erie, Pennsylvania, United States

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Sewickley, Pennsylvania, United States

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Columbia, South Carolina, United States

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Orangeburg, South Carolina, United States

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Sumter, South Carolina, United States

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Chattanooga, Tennessee, United States

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Hendersonville, Tennessee, United States

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Hixon, Tennessee, United States

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Memphis, Tennessee, United States

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Nashville, Tennessee, United States

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Austin, Texas, United States

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Beaumont, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Provo, Utah, United States

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Salt Lake City, Utah, United States

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McLean, Virginia, United States

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Norton, Virginia, United States

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Puyallup, Washington, United States

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Seattle, Washington, United States

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Spokane, Washington, United States

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Tacoma, Washington, United States

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Walla Walla, Washington, United States

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Milwaukee, Wisconsin, United States

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Related Publications (1)

• Pencek R, Roddy T, Peters Y, De Young MB, Herrmann K, Meller L, Nguyen H, Chen S, Lutz K. Safety of pramlintide added to mealtime insulin in patients with type 1 or type 2 diabetes: a large observational study. Diabetes Obes Metab. 2010 Jun;12(6):548-51. doi: 10.1111/j.1463-1326.2010.01201.x.

  PMID: 20518811 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

pramlintide

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Study Officials

• Vice President, Medical Development, MD

  Amylin Pharmaceuticals, LLC.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2005
• First Posted: September 30, 2005
• Study Start: September 1, 2005
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: March 25, 2015
• Results First Posted: June 24, 2009

Record last verified: 2015-02

Locations

US (107)