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Trial · Observational

CompletedPhase not statedResults postedRegistry data

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

NCTNCT00229658 (opens ClinicalTrials.gov in a new tab)Other id137-161
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase not stated
Enrollment
1,297 participants (actual)
Sponsor
AstraZeneca · Industry
Design
Not stated
Countries
1 country

United States

Start
Sept 2005
Primary completion
May 2008
Completion
May 2008
First posted
30 Sept 2005 (estimated)
Last update posted
25 Mar 2015 (estimated)
Conditions
Type 1 Diabetes Mellitus · Type 2 Diabetes Mellitus

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20052006200720082009
  1. Ph –

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

    NCT00229658

    Sept 2005 to May 2008

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • pramlintide acetateDrug

Arms2

  • Other

    Type 1

    Patients with type 1 diabetes

  • Other

    Type 2

    Patients with type 2 diabetes

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Incidence of Patient-Ascertained Severe Hypoglycemia (PASH) During the Adjustment Period

    Time frame · 0-3 months

    Registry description

    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

    Registry description

    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(10)

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

    Time frame · >3-6 months

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    Mean change in body weight from baseline at month 3

  10. Change in Body Weight From Baseline at Month 6

    Time frame · 6 months

    Registry description

    Mean change in body weight from baseline at month 6

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· 0-3 months

Incidence of Patient-Ascertained Severe Hypoglycemia (PASH) During the Adjustment Period

GroupValue (Incidence (%))
Type 1 Diabetes4.8
Type 2 Diabetes2.8
Primary outcomeNumber· 0-3 months

Annual Event Rate of Patient-Ascertained Severe Hypoglycemia (PASH) During the Adjustment Period

GroupValue (Events per patient year)
Type 1 Diabetes0.3255
Type 2 Diabetes0.1941
Secondary and other outcome results(6)
Secondary outcomeNumber· >3-6 months

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

GroupValue (Incidence (%))
Type 1 Diabetes1.8
Type 2 Diabetes0.3
Secondary outcomeNumber· >3-6 months

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

GroupValue (Events per patient year)
Type 1 Diabetes0.0844
Type 2 Diabetes0.0248
Secondary outcomeNumber· 0-3 months

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

GroupValue (Incidence (%))
Type 1 Diabetes1.8
Type 2 Diabetes0.4
Secondary outcomeNumber· 0-3 months

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

GroupValue (Events per patient year)
Type 1 Diabetes0.0996
Type 2 Diabetes0.0185
Secondary outcomeNumber· >3-6 months

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

GroupValue (Incidence (%))
Type 1 Diabetes0.8
Type 2 Diabetes0.3
Secondary outcomeNumber· >3-6 months

Annual Event Rate of Medically Assisted Severe Hypoglycemia (MASH) During the Steady State Period

GroupValue (Events per patient year)
Type 1 Diabetes0.0375
Type 2 Diabetes0.0124

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Type 1 DiabetesInsulin using patients with Type 1 diabetes–14 / ?0 / 766
Type 2 DiabetesInsulin using patients with Type 2 diabetes–13 / ?0 / 531

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

More studies

1 study on this page

PubMed tag: none · 2010

Safety of pramlintide added to mealtime insulin in patients with type 1 or type 2 diabetes: a large observational study.

Pencek et al. 2010Diabetes, obesity & metabolismcited by 16

PMID 20518811DOI 10.1111/j.1463-1326.2010.01201.xPUB-20518811

Rights unknown
Source link

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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