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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00229658
• Other study ID #: 137-161
• Status: Completed
• Phase: N/A
• First received: September 28, 2005
• Last updated: March 5, 2015
• Start date: September 2005
• Est. completion date: May 2008

Study information

• Verified date: February 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1297
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2
• Type 1 Diabetes Mellitus
• Type 2 Diabetes Mellitus

Intervention

Drug:
• pramlintide acetate
Subcutaneous injection prior to each major meal

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Secondary	The Incidence of Patient-Ascertained Severe Hypoglycemia (PASH) During the Steady State 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	Yes
Secondary	The Annual Event Rate of Patient-Ascertained Severe Hypoglycemia (PASH) During the Steady State 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 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	Yes
Secondary	Incidence of Medically Assisted Severe Hypoglycemia (MASH) During 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. The adjustment period represents the initial 0-3 months of pramlintide treatment	0-3 months	Yes
Secondary	The Annual Event Rate of Medically Assisted Severe Hypoglycemia (MASH) 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.; 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	Yes
Secondary	Incidence of Medically Assisted Severe Hypoglycemia (MASH) During the Steady State 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	Yes
Secondary	Annual Event Rate of Medically Assisted Severe Hypoglycemia (MASH) During the Steady State 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 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	Yes
Secondary	Change in HbA1c From Baseline at Month 3	Change in HbA1c from baseline at month 3. The HbA1c test measures the percent of glycosylated hemoglobin in the blood.	3 months	No
Secondary	Change in HbA1c From Baseline at Month 6	Change in HbA1c from baseline at month 6. The HbA1c test measures the percent of glycosylated hemoglobin in the blood.	6 months	No
Secondary	Change in Body Weight From Baseline at Month 3	Mean change in body weight from baseline at month 3	3 months	No
Secondary	Change in Body Weight From Baseline at Month 6	Mean change in body weight from baseline at month 6	6 months	No