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CompletedNCT00229658Updated Mar 25, 2015Results posted

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

An observational study in Type 1 Diabetes Mellitus and Type 2 Diabetes Mellitus, sponsored by AstraZeneca. Completed at 107 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-03-25.

Sponsored by AstraZeneca · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
1,297
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Type 1 Diabetes Mellitus
  • Type 2 Diabetes Mellitus

Keywords

  • diabetes
  • pramlintide
  • Symlin
  • Amylin
  • phase 4
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 1,297 is above the median of 233 across 2,220 observational studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

cross-section of clinical practice settings

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

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
05

Study design

Time perspective
Prospective
Enrollment
1,297 participants (actual)

Groups and cohorts

  • Type 1

    Patients with type 1 diabetes

    Drug: pramlintide acetate

  • Type 2

    Patients with type 2 diabetes

    Drug: pramlintide acetate

Interventions

  • Drugpramlintide acetate

    Subcutaneous injection prior to each major meal

    Also known as: Symlin

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 0-3 months

  2. 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.

    Time frame: 0-3 months

Secondary outcomes

  1. 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.

    Time frame: >3-6 months

  2. 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.

    Time frame: >3-6 months

  3. 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

    Time frame: 0-3 months

  4. 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.

    Time frame: 0-3 months

  5. 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.

    Time frame: >3-6 months

  6. 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.

    Time frame: >3-6 months

  7. 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.

    Time frame: 3 months

  8. 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.

    Time frame: 6 months

  9. Change in Body Weight From Baseline at Month 3

    Mean change in body weight from baseline at month 3

    Time frame: 3 months

  10. Change in Body Weight From Baseline at Month 6

    Mean change in body weight from baseline at month 6

    Time frame: 6 months

07

Results

Posted Jun 24, 2009

Participant flow

Participant flow — Overall Study
MilestoneType 1 DiabetesType 2 Diabetes
Started766531
Completed541364
Not completed225167
Withdrew: Administrative21
Withdrew: Investigator decision1310
Withdrew: Other8060
Withdrew: Lost to follow-up8255
Withdrew: Serious adverse event22
Withdrew: Withdrawal of consent4639

Outcome measures

PrimaryIncidence 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

Time frame:
0-3 months
Reported as:
Number · Incidence (%)
Incidence of Patient-Ascertained Severe Hypoglycemia (PASH) During the Adjustment Period
Incidence (%)Type 1 DiabetesType 2 Diabetes
Incidence of Patient-Ascertained Severe Hypoglycemia (PASH) During the Adjustment Period4.82.8
PrimaryAnnual 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.

Time frame:
0-3 months
Reported as:
Number · Events per patient year
Annual Event Rate of Patient-Ascertained Severe Hypoglycemia (PASH) During the Adjustment Period
Events per patient yearType 1 DiabetesType 2 Diabetes
Annual Event Rate of Patient-Ascertained Severe Hypoglycemia (PASH) During the Adjustment Period0.32550.1941
SecondaryThe 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.

Time frame:
>3-6 months
Reported as:
Number · Incidence (%)
The Incidence of Patient-Ascertained Severe Hypoglycemia (PASH) During the Steady State Period
Incidence (%)Type 1 DiabetesType 2 Diabetes
The Incidence of Patient-Ascertained Severe Hypoglycemia (PASH) During the Steady State Period1.80.3
SecondaryThe 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.

Time frame:
>3-6 months
Reported as:
Number · Events per patient year
The Annual Event Rate of Patient-Ascertained Severe Hypoglycemia (PASH) During the Steady State Period
Events per patient yearType 1 DiabetesType 2 Diabetes
The Annual Event Rate of Patient-Ascertained Severe Hypoglycemia (PASH) During the Steady State Period0.08440.0248
SecondaryIncidence 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

Time frame:
0-3 months
Reported as:
Number · Incidence (%)
Incidence of Medically Assisted Severe Hypoglycemia (MASH) During the Adjustment Period
Incidence (%)Type 1 DiabetesType 2 Diabetes
Incidence of Medically Assisted Severe Hypoglycemia (MASH) During the Adjustment Period1.80.4
SecondaryThe 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.

Time frame:
0-3 months
Reported as:
Number · Events per patient year
The Annual Event Rate of Medically Assisted Severe Hypoglycemia (MASH) During the Adjustment Period
Events per patient yearType 1 DiabetesType 2 Diabetes
The Annual Event Rate of Medically Assisted Severe Hypoglycemia (MASH) During the Adjustment Period0.09960.0185
SecondaryIncidence 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.

Time frame:
>3-6 months
Reported as:
Number · Incidence (%)
Incidence of Medically Assisted Severe Hypoglycemia (MASH) During the Steady State Period
Incidence (%)Type 1 DiabetesType 2 Diabetes
Incidence of Medically Assisted Severe Hypoglycemia (MASH) During the Steady State Period0.80.3
SecondaryAnnual 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.

Time frame:
>3-6 months
Reported as:
Number · Events per patient year
Annual Event Rate of Medically Assisted Severe Hypoglycemia (MASH) During the Steady State Period
Events per patient yearType 1 DiabetesType 2 Diabetes
Annual Event Rate of Medically Assisted Severe Hypoglycemia (MASH) During the Steady State Period0.03750.0124
SecondaryChange 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.

Time frame:
3 months
Reported as:
Mean · percent
Change in HbA1c From Baseline at Month 3
percentType 1 DiabetesType 2 Diabetes
Change in HbA1c From Baseline at Month 3-0.12 ± 0.037-0.33 ± 0.056
SecondaryChange 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.

Time frame:
6 months
Reported as:
Mean · percent
Change in HbA1c From Baseline at Month 6
percentType 1 DiabetesType 2 Diabetes
Change in HbA1c From Baseline at Month 6-0.26 ± 0.046-0.44 ± 0.071
SecondaryChange in Body Weight From Baseline at Month 3

Mean change in body weight from baseline at month 3

Time frame:
3 months
Reported as:
Mean · kg
Change in Body Weight From Baseline at Month 3
kgType 1 DiabetesType 2 Diabetes
Change in Body Weight From Baseline at Month 3-1.95 ± 0.154-1.94 ± 0.237
SecondaryChange in Body Weight From Baseline at Month 6

Mean change in body weight from baseline at month 6

Time frame:
6 months
Reported as:
Mean · kg
Change in Body Weight From Baseline at Month 6
kgType 1 DiabetesType 2 Diabetes
Change in Body Weight From Baseline at Month 6-2.77 ± 0.246-1.98 ± 0.322

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Type 1 Diabetes——0/766 (0%)
Type 2 Diabetes——0/531 (0%)
Most frequent serious events
Showing 10 of 29
Most frequent serious events
EventType 1 DiabetesType 2 Diabetes
Diabetic ketoacidosisMetabolism and nutrition disorders3/7660/531
SepsisInfections and infestations0/7662/531
Atrioventricular block completeCardiac disorders0/7661/531
Cardiac failure congestiveCardiac disorders1/7661/531
Coronary artery diseaseCardiac disorders0/7661/531
Myocardial infarctionCardiac disorders0/7661/531
Chest painGeneral disorders0/7661/531
Hernia obstructiveGeneral disorders0/7661/531
CellulitisInfections and infestations0/7661/531
DiverticulitisInfections and infestations0/7661/531

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Type 1 DiabetesType 2 DiabetesTotal
<=18 years808
Between 18 and 65 years7214061127
>=65 years37125162
Age, Continuous
Age, Continuous(years)Type 1 DiabetesType 2 DiabetesTotal
Mean43.2 ± 13.2256.9 ± 11.1048.8 ± 14.10
Sex: Female, Male
Sex: Female, Male(Participants)Type 1 DiabetesType 2 DiabetesTotal
Female500296796
Male266235501
Region of Enrollment
Region of Enrollment(participants)Type 1 DiabetesType 2 DiabetesTotal
United States7665311297
Body Weight
Body Weight(kg)Type 1 DiabetesType 2 DiabetesTotal
Mean87.21 ± 19.843112.53 ± 24.79097.57 ± 25.273
Duration of Diabetes
Duration of Diabetes(years)Type 1 DiabetesType 2 DiabetesTotal
Mean20.66 ± 11.70914.76 ± 8.35518.24 ± 10.857
HbA1c
HbA1c(%)Type 1 DiabetesType 2 DiabetesTotal
Mean7.86 ± 1.0828.23 ± 1.5388.01 ± 1.301
08

Study locations

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

Showing the first 100 of 107 sites.

09

References and documents

Publications

  • 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. PubMed 20518811 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 25, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00229658
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Sep 30, 2005
Start date
Sep 2005
Primary completion
May 2008
Completion
May 2008
Results posted
Jun 24, 2009
Last update
Mar 25, 2015

Study contacts

Vice President, Medical Development, MD
study director · Amylin Pharmaceuticals, LLC.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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