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CompletedResults posted

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

Lead sponsor

AstraZeneca

Asset

Pramlintide

Subcutaneous · Amylin analog

Listed sites

107

Recruiting sites

—

Enrollment

1,297

actual

Study population

Type 1 diabetes, Type 2 diabetes

Key I/E criterion

•HbA1c ≤9%

Primary endpoint

•Severe hypoglycemia

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT00229658
Org study ID137-161

Timeline

Milestones

Study first posted2005-09-30estimated
Results first posted2009-06-24estimated
Last update posted2015-03-25estimated
Study start2005-09 (month precision)
Primary completion2008-05actual (month precision)
Study completion2008-05actual (month precision)

Assets

Investigational agents

Pramlintide

Study populations

Who this study enrolls

Type 1 diabetesType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted
Sampling methodNon probability sample

Study population text

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

•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

Endpoints (12)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK
8
Weight & body composition
2
Glycemic / diabetes
2

Weight & body composition

2 endpoints
Secondary/protocol endpoint

Change in Body Weight From Baseline at Month 3

Time frame:3 months

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

GroupValue (mean), kg95% CI
Type 1 Diabetes-1.95—
Type 2 Diabetes-1.94—
Secondary/protocol endpoint

Change in Body Weight From Baseline at Month 6

Time frame:6 months

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

GroupValue (mean), kg95% CI
Type 1 Diabetes-2.77—
Type 2 Diabetes-1.98—

Glycemic / diabetes

2 endpoints
Secondary/protocol endpoint

Change in HbA1c From Baseline at Month 3

Time frame:3 months

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

GroupValue (mean), percent95% CI
Type 1 Diabetes-0.12—
Type 2 Diabetes-0.33—
Secondary/protocol endpoint

Change in HbA1c From Baseline at Month 6

Time frame:6 months

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

GroupValue (mean), percent95% CI
Type 1 Diabetes-0.26—
Type 2 Diabetes-0.44—

Safety / tolerability / PK

8 endpoints
Primary/protocol endpoint

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

Time frame:0-3 months

Severe hypoglycemia

event count, event

Posted result

GroupValue (number), Incidence (%)95% CI
Type 1 Diabetes4.8—
Type 2 Diabetes2.8—
Primary/protocol endpoint

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

Time frame:0-3 months

Severe hypoglycemia

event count, event

Posted result

GroupValue (number), Events per patient year95% CI
Type 1 Diabetes0.3255—
Type 2 Diabetes0.1941—
Secondary/protocol endpoint

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

Time frame:>3-6 months

Severe hypoglycemia

event count, event

Posted result

GroupValue (number), Incidence (%)95% CI
Type 1 Diabetes1.8—
Type 2 Diabetes0.3—
Secondary/protocol endpoint

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

Time frame:>3-6 months

Severe hypoglycemia

event count, event

Posted result

GroupValue (number), Events per patient year95% CI
Type 1 Diabetes0.0844—
Type 2 Diabetes0.0248—
Secondary/protocol endpoint

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

Time frame:0-3 months

Severe hypoglycemia

event count, event

Posted result

GroupValue (number), Incidence (%)95% CI
Type 1 Diabetes1.8—
Type 2 Diabetes0.4—
Secondary/protocol endpoint

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

Time frame:0-3 months

Severe hypoglycemia

event count, event

Posted result

GroupValue (number), Events per patient year95% CI
Type 1 Diabetes0.0996—
Type 2 Diabetes0.0185—
Secondary/protocol endpoint

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

Time frame:>3-6 months

Severe hypoglycemia

event count, event

Posted result

GroupValue (number), Incidence (%)95% CI
Type 1 Diabetes0.8—
Type 2 Diabetes0.3—
Secondary/protocol endpoint

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

Time frame:>3-6 months

Severe hypoglycemia

event count, event

Posted result

GroupValue (number), Events per patient year95% CI
Type 1 Diabetes0.0375—
Type 2 Diabetes0.0124—

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.