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

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

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

NCT00229658•AstraZeneca

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•* 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

•* 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

Locations (107)

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

Key Dates

Start Date

September 1, 2005

Primary Completion Date

May 1, 2008

Completion Date

May 1, 2008

Last Updated

March 25, 2015

Enrollment

1,297

ACTUAL participants

Conditions

Type 1 Diabetes MellitusType 2 Diabetes Mellitus

Interventions

pramlintide acetate

DRUG

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

View study

RECRUITINGNA

Achieving Routine Intervention and Screening for Emotional Health

NCT06887049

Type 2 Diabetes Mellitus (T2DM)Diabetes Distress

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 25, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

Achieving Routine Intervention and Screening for Emotional Health

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