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Completed

NCT Number: NCT00229658

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

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.

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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases Type 2 Diabetes Mellitus

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pramlintide acetate

Drug

Subcutaneous injection prior to each major meal

Other names: Symlin

Primary outcomes

  1. 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

  2. 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.

Secondary outcomes

  1. 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.

  2. 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. 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

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. Change in Body Weight From Baseline at Month 3

    Time frame: 3 months

    Mean change in body weight from baseline at month 3

  10. Change in Body Weight From Baseline at Month 6

    Time frame: 6 months

    Mean change in body weight from baseline at month 6

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Sep 30, 2005
Registry last updated
Mar 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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