Clinical trial NCT00229658: An Observational Study Evaluating SYMLIN® (Pramlintide Acetate) Injection Use in Insulin Using Patients With Type 2 and Type 1 Diabetes
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes Mellitus
Type 2 Diabetes Mellitus
Keywords: diabetes
pramlintide
Symlin
Amylin
phase 4
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-09-30
Enrollment: 1297
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: cross-section of clinical practice settings

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Patient-Ascertained Severe Hypoglycemia (PASH) During the Adjustment Period
timeFrame: 0-3 months
measure: Annual Event Rate of Patient-Ascertained Severe Hypoglycemia (PASH) During the Adjustment Period
timeFrame: 0-3 months
Secondary outcomes:
measure: The Incidence of Patient-Ascertained Severe Hypoglycemia (PASH) During the Steady State Period
timeFrame: >3-6 months
measure: The Annual Event Rate of Patient-Ascertained Severe Hypoglycemia (PASH) During the Steady State Period
timeFrame: >3-6 months
measure: Incidence of Medically Assisted Severe Hypoglycemia (MASH) During the Adjustment Period
timeFrame: 0-3 months
measure: The Annual Event Rate of Medically Assisted Severe Hypoglycemia (MASH) During the Adjustment Period
timeFrame: 0-3 months
measure: Incidence of Medically Assisted Severe Hypoglycemia (MASH) During the Steady State Period
timeFrame: >3-6 months
measure: Annual Event Rate of Medically Assisted Severe Hypoglycemia (MASH) During the Steady State Period
timeFrame: >3-6 months
measure: Change in HbA1c From Baseline at Month 3
timeFrame: 3 months
measure: Change in HbA1c From Baseline at Month 6
timeFrame: 6 months
measure: Change in Body Weight From Baseline at Month 3
timeFrame: 3 months
measure: Change in Body Weight From Baseline at Month 6
timeFrame: 6 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Montgomery
country: United States
facility: Research Site
state: Alabama
city: Tucson
country: United States
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state: Arizona
city: Anaheim
country: United States
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state: California
city: Encinitas
country: United States
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state: California
city: Escondido
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state: California
city: Fresno
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state: California
city: Lafayette
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state: California
city: Moreno Valley
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city: Sacramento
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city: Salinas
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city: Santa Barbara
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city: Torrance
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city: Arvada
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state: Colorado
city: Aurora
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state: Colorado
city: Norwalk
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state: Connecticut
city: Wilmington
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city: Hialeah
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city: Jacksonville
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city: Winter Haven
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city: Canton
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state: Georgia
city: Columbus
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city: Roswell
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city: Valdosta
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state: Hawaii
city: Caldwell
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state: Idaho
city: Idaho Falls
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city: Pocatello
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city: Evergreen Park
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city: Wheaton
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city: Fort Wayne
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city: Franklin
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city: Indianapolis
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city: Des Moines
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city: Shawnee Mission
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city: Wichita
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city: Louisville
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city: Baton Rouge
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city: Lafayette
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city: Laplace
country: United States
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state: Louisiana
city: Glen Burnie
country: United States
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state: Maryland
city: Towson
country: United States
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state: Maryland
city: Ann Arbor
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city: Bloomfield
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city: Detroit
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city: Grand Rapids
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city: Eagan
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city: Butte
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city: Las Vegas
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city: Reno
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city: Hamilton
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city: Jersey City
country: United States
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city: Livingston
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city: Moorestown
country: United States
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city: Neptune
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city: North Plainfield
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city: Albany
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city: Binghamton
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city: Forest Hills
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city: Lawrence
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city: New York
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city: Riverhead
country: United States
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city: Rochester
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state: New York
city: Staten Island
country: United States
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state: New York
city: Utica
country: United States
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state: New York
city: Greensboro
country: United States
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state: North Carolina
city: Morehead City
country: United States
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state: North Carolina
city: Raleigh
country: United States
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state: North Carolina
city: Cincinnati
country: United States
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state: Ohio
city: Columbus
country: United States
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state: Ohio
city: Mentor
country: United States
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state: Ohio
city: Toledo
country: United States
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state: Ohio
city: Portland
country: United States
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state: Oregon
city: Salem
country: United States
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state: Oregon
city: Bridgeville
country: United States
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state: Pennsylvania
city: Carlisle
country: United States
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state: Pennsylvania
city: Erie
country: United States
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state: Pennsylvania
city: Sewickley
country: United States
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state: Pennsylvania
city: Columbia
country: United States
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state: South Carolina
city: Orangeburg
country: United States
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state: South Carolina
city: Sumter
country: United States
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state: South Carolina
city: Chattanooga
country: United States
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state: Tennessee
city: Hendersonville
country: United States
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state: Tennessee
city: Hixon
country: United States
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state: Tennessee
city: Memphis
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city: Nashville
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state: Tennessee
city: Austin
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state: Texas
city: Beaumont
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city: Houston
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city: San Antonio
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city: Provo
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state: Utah
city: Salt Lake City
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state: Utah
city: McLean
country: United States
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state: Virginia
city: Norton
country: United States
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state: Virginia
city: Puyallup
country: United States
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state: Washington
city: Seattle
country: United States
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state: Washington
city: Spokane
country: United States
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state: Washington
city: Tacoma
country: United States
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state: Washington
city: Walla Walla
country: United States
facility: Research Site
state: Washington
city: Milwaukee
country: United States
facility: Research Site
state: Wisconsin
Study officials:
affiliation: Amylin Pharmaceuticals, LLC.
name: Vice President, Medical Development, MD
role: STUDY_DIRECTOR
References:
citation: 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.