Type 1 Diabetes MellitusNCT00229658

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

An observational study of Type 1 Diabetes Mellitus and Type 2 Diabetes Mellitus, run by AstraZeneca at 107 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
What is being tested?: pramlintide acetate
Type of treatment: Injection or infusion
How many people: 1,297 participants
Where: 107 sitesUnited States
Study dates: Sep 2005to May 2008
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: cross-section of clinical practice settings

Who may be able to join

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

Who cannot join

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

Show all 9Show fewer

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

Trial locations and contacts

107 sites in 1 country.

City, postcode or hospital

107 sites in 1 country

United States107 sites

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

Other trials in United States

About this study

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

Conditions: Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
Being tested: pramlintide acetate
Keywords: diabetes, pramlintide, Symlin, Amylin, phase 4
Medical subject headings: Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

pramlintide acetateDrug
Also called Symlin
Subcutaneous injection prior to each major meal

Study groups in NCT00229658
Study group	Role	What they receive
Type 1		Patients with type 1 diabetes Receives: Drug: pramlintide acetate
Type 2		Patients with type 2 diabetes Receives: Drug: pramlintide acetate

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 0-3 months
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.
Measured: 0-3 months

Secondary outcomes (10)

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.
Measured: >3-6 months
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.
Measured: >3-6 months
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
Measured: 0-3 months
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.
Measured: 0-3 months
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.
Measured: >3-6 months
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.
Measured: >3-6 months
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.
Measured: 3 months
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.
Measured: 6 months
Change in Body Weight From Baseline at Month 3
Mean change in body weight from baseline at month 3
Measured: 3 months
Change in Body Weight From Baseline at Month 6
Mean change in body weight from baseline at month 6
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2005May 2008

First posted30 Sep 2005 (estimated)
Study startSep 2005
Primary completionMay 2008
Study completionMay 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Time perspective: Prospective
Enrolment: 1,297 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00229658
Sponsor's protocol ID: 137-161
Status last verified: Feb 2015
First submitted: 28 Sep 2005
Last updated: 25 Mar 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Type 1 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00229658
Acronym / sponsor ID: 137-161
Conditions: Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
Keywords: diabetes, pramlintide, Symlin, Amylin, phase 4
Study type: Observational
Recruitment status: Completed
Enrolment: 1,297 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Sep 2005
Primary completion: May 2008 (actual)
Study completion: May 2008 (actual)
First posted: 30 Sep 2005 (estimated)
Results: Posted 24 Jun 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Type 1	–	Drug: pramlintide acetatePatients with type 1 diabetes
Type 2	–	Drug: pramlintide acetatePatients with type 2 diabetes

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: cross-section of clinical practice settings

Key inclusion criteria (4 listed)

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:

Key exclusion criteria (9 listed)

The following exclusion criteria are consistent with the SYMLIN package insert and specifically exclude patients who:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
pramlintide acetateAlso: SymlinSubcutaneous injection prior to each major meal	Drug	Type 1, Type 2

Primary outcome

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
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.

10 secondary outcomes

The Incidence of Patient-Ascertained Severe Hypoglycemia (PASH) During the Steady State Period
Time frame: >3-6 months
The Annual Event Rate of Patient-Ascertained Severe Hypoglycemia (PASH) During the Steady State Period
Time frame: >3-6 months
Incidence of Medically Assisted Severe Hypoglycemia (MASH) During the Adjustment Period
Time frame: 0-3 months
The Annual Event Rate of Medically Assisted Severe Hypoglycemia (MASH) During the Adjustment Period
Time frame: 0-3 months
Incidence of Medically Assisted Severe Hypoglycemia (MASH) During the Steady State Period
Time frame: >3-6 months
Annual Event Rate of Medically Assisted Severe Hypoglycemia (MASH) During the Steady State Period
Time frame: >3-6 months
Change in HbA1c From Baseline at Month 3
Time frame: 3 months
Change in HbA1c From Baseline at Month 6
Time frame: 6 months
Change in Body Weight From Baseline at Month 3
Time frame: 3 months
Change in Body Weight From Baseline at Month 6
Time frame: 6 months

Results and safety

Results posted to the registry on 24 Jun 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Type 1 Diabetes	766	541
Type 2 Diabetes	531	364

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

Time frame: 0-3 months. Number. Unit: Incidence (%)

Measure	Type 1 Diabetes n = 766	Type 2 Diabetes n = 531
Value	4.8	2.8

Population analysed: Intent-to-Treat

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

Time frame: 0-3 months. Number. Unit: Events per patient year

Measure	Type 1 Diabetes n = 766	Type 2 Diabetes n = 531
Value	0.3255	0.1941

Population analysed: Intent-to-Treat

10 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Type 1 Diabetes	14 of ?	0 of 766 (0%)	Not reported
Type 2 Diabetes	13 of ?	0 of 531 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 20518811Pencek 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.

Related trials for Type 1 Diabetes Mellitus

Not yet recruiting
Care COMPASS Study
Diabetes Mellitus ( Type 1 and Type 2), Hypertension
Recruiting
Starting Technology in At Risk Type 1 Diabetes Study
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Active, not recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Vice President, Medical Development, MD study director

Amylin Pharmaceuticals, LLC.

107 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Type 1 Diabetes Mellitus and Type 2 Diabetes Mellitus, run by AstraZeneca at 107 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 107 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Jun 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Patient-Ascertained Severe Hypoglycemia (PASH) During the Adjustment Period (time frame: 0-3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00229658, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2015.