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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00229658
First received: September 28, 2005
Last updated: June 4, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Type 1 Diabetes Mellitus
Type 2 Diabetes Mellitus
Drug: pramlintide acetate

Study Type: Observational
Study Design: Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Incidence of Patient-Ascertained Severe Hypoglycemia (PASH) During the Adjustment Period [ Time Frame: 0-3 months ] [ Designated as safety issue: Yes ]
    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

  • Annual Event Rate of Patient-Ascertained Severe Hypoglycemia (PASH) During the Adjustment Period [ Time Frame: 0-3 months ] [ Designated as safety issue: Yes ]

    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.



Secondary Outcome Measures:
  • The Incidence of Patient-Ascertained Severe Hypoglycemia (PASH) During the Steady State Period [ Time Frame: >3-6 months ] [ Designated as safety issue: Yes ]

    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.


  • The Annual Event Rate of Patient-Ascertained Severe Hypoglycemia (PASH) During the Steady State Period [ Time Frame: >3-6 months ] [ Designated as safety issue: Yes ]

    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.


  • Incidence of Medically Assisted Severe Hypoglycemia (MASH) During the Adjustment Period [ Time Frame: 0-3 months ] [ Designated as safety issue: Yes ]
    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

  • The Annual Event Rate of Medically Assisted Severe Hypoglycemia (MASH) During the Adjustment Period [ Time Frame: 0-3 months ] [ Designated as safety issue: Yes ]

    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.


  • Incidence of Medically Assisted Severe Hypoglycemia (MASH) During the Steady State Period [ Time Frame: >3-6 months ] [ Designated as safety issue: Yes ]

    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.


  • Annual Event Rate of Medically Assisted Severe Hypoglycemia (MASH) During the Steady State Period [ Time Frame: >3-6 months ] [ Designated as safety issue: Yes ]

    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.


  • Change in HbA1c From Baseline at Month 3 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Change in HbA1c from baseline at month 3. The HbA1c test measures the percent of glycosylated hemoglobin in the blood.

  • Change in HbA1c From Baseline at Month 6 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Change in HbA1c from baseline at month 6. The HbA1c test measures the percent of glycosylated hemoglobin in the blood.

  • Change in Body Weight From Baseline at Month 3 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Mean change in body weight from baseline at month 3

  • Change in Body Weight From Baseline at Month 6 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Mean change in body weight from baseline at month 6


Enrollment: 1297
Study Start Date: September 2005
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Type 1
Patients with type 1 diabetes
Drug: pramlintide acetate
Subcutaneous injection prior to each major meal
Other Name: Symlin
Type 2
Patients with type 2 diabetes
Drug: pramlintide acetate
Subcutaneous injection prior to each major meal
Other Name: Symlin

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

cross-section of clinical practice settings

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00229658

  Show 107 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Vice President, Medical Development, MD Amylin Pharmaceuticals, LLC.
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00229658     History of Changes
Other Study ID Numbers: 137-161
Study First Received: September 28, 2005
Results First Received: May 5, 2009
Last Updated: June 4, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
diabetes
pramlintide
Symlin
Amylin
phase 4

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Pramlintide
Islet Amyloid Polypeptide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Appetite Depressants
Anti-Obesity Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 25, 2014