Trial · NCT00229658

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

NCT00229658, Completed, AstraZeneca; results first posted 2009-06-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. An Observational Study Evaluating SYMLIN® (Pramlintide Acetate) Injection Use in Insulin Using Patients With Type 2 and Type 1 Diabetes. Trials, record NCT00229658. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00229658

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: An Observational Study Evaluating SYMLIN® (Pramlintide Acetate) Injection Use in Insulin Using Patients With Type 2 and Type 1 Diabetes
NCT number: NCT00229658
Status: Completed
Enrollment: 1,297 participants, actual
Lead sponsor: AstraZeneca
Conditions: Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
Interventions: pramlintide acetate
First posted: 2005-09-30
Last updated: 2015-03-25
Results first posted: 2009-06-24

Source ClinicalTrials.gov

Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Incidence of Patient-Ascertained Severe Hypoglycemia (PASH) During the Adjustment Period	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
Primary	Annual Event Rate of Patient-Ascertained Severe Hypoglycemia (PASH) During the Adjustment Period	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.
Secondary	The Incidence of Patient-Ascertained Severe Hypoglycemia (PASH) During the Steady State Period	>3-6 months	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.
Secondary	The Annual Event Rate of Patient-Ascertained Severe Hypoglycemia (PASH) During the Steady State Period	>3-6 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 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.
Secondary	Incidence of Medically Assisted Severe Hypoglycemia (MASH) During the Adjustment Period	0-3 months	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
Secondary	The Annual Event Rate of Medically Assisted Severe Hypoglycemia (MASH) During the Adjustment Period	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. 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.
Secondary	Incidence of Medically Assisted Severe Hypoglycemia (MASH) During the Steady State Period	>3-6 months	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.
Secondary	Annual Event Rate of Medically Assisted Severe Hypoglycemia (MASH) During the Steady State Period	>3-6 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 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.
Secondary	Change in HbA1c From Baseline at Month 3	3 months	Change in HbA1c from baseline at month 3. The HbA1c test measures the percent of glycosylated hemoglobin in the blood.
Secondary	Change in HbA1c From Baseline at Month 6	6 months	Change in HbA1c from baseline at month 6. The HbA1c test measures the percent of glycosylated hemoglobin in the blood.

1 to 10 of 12Source ClinicalTrials.gov

See all 12 registered outcomes

Outcomes12

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Incidence of Patient-Ascertained Severe Hypoglycemia (PASH) During the Adjustment Period	0-3 months	Intent-to-Treat	Incidence (%)	NUMBER
PRIMARY	Annual Event Rate of Patient-Ascertained Severe Hypoglycemia (PASH) During the Adjustment Period	0-3 months	Intent-to-Treat	Events per patient year	NUMBER
SECONDARY	The Incidence of Patient-Ascertained Severe Hypoglycemia (PASH) During the Steady State Period	>3-6 months	Intent-to-Treat, number analyzed includes patients still enrolled in the study during the steady-state period (3-6 months)	Incidence (%)	NUMBER
SECONDARY	The Annual Event Rate of Patient-Ascertained Severe Hypoglycemia (PASH) During the Steady State Period	>3-6 months	Intent-to-Treat, number analyzed includes patients still enrolled in the study during the steady-state period (3-6 months)	Events per patient year	NUMBER
SECONDARY	Incidence of Medically Assisted Severe Hypoglycemia (MASH) During the Adjustment Period	0-3 months	Intent-to-Treat.	Incidence (%)	NUMBER
SECONDARY	The Annual Event Rate of Medically Assisted Severe Hypoglycemia (MASH) During the Adjustment Period	0-3 months	Intent-to-Treat	Events per patient year	NUMBER
SECONDARY	Incidence of Medically Assisted Severe Hypoglycemia (MASH) During the Steady State Period	>3-6 months	Intent-to-Treat, number analyzed includes patients still enrolled in the study during the steady-state period (3-6 months)	Incidence (%)	NUMBER
SECONDARY	Annual Event Rate of Medically Assisted Severe Hypoglycemia (MASH) During the Steady State Period	>3-6 months	Intent-to-Treat, number analyzed includes patients still enrolled in the study during the steady-state period (3-6 months)	Events per patient year	NUMBER
SECONDARY	Change in HbA1c From Baseline at Month 3	3 months	Intent-to-Treat, patients who discontinue SYMLIN 7 or more days prior to a site visit are not included in the analyses	percent	MEAN
SECONDARY	Change in HbA1c From Baseline at Month 6	6 months	Intent-to-Treat, patients who discontinue SYMLIN 7 or more days prior to a site visit are not included in the analyses	percent	MEAN

1 to 10 of 12Source ClinicalTrials.gov

See all 12 outcomes

Results by group24

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Incidence of Patient-Ascertained Severe Hypoglycemia (PASH) During the Adjustment Period	Type 1 Diabetes	4.8	Incidence (%)
Incidence of Patient-Ascertained Severe Hypoglycemia (PASH) During the Adjustment Period	Type 2 Diabetes	2.8	Incidence (%)
Annual Event Rate of Patient-Ascertained Severe Hypoglycemia (PASH) During the Adjustment Period	Type 1 Diabetes	0.3255	Events per patient year
Annual Event Rate of Patient-Ascertained Severe Hypoglycemia (PASH) During the Adjustment Period	Type 2 Diabetes	0.1941	Events per patient year
The Incidence of Patient-Ascertained Severe Hypoglycemia (PASH) During the Steady State Period	Type 1 Diabetes	1.8	Incidence (%)
The Incidence of Patient-Ascertained Severe Hypoglycemia (PASH) During the Steady State Period	Type 2 Diabetes	0.3	Incidence (%)
The Annual Event Rate of Patient-Ascertained Severe Hypoglycemia (PASH) During the Steady State Period	Type 1 Diabetes	0.0844	Events per patient year
The Annual Event Rate of Patient-Ascertained Severe Hypoglycemia (PASH) During the Steady State Period	Type 2 Diabetes	0.0248	Events per patient year
Incidence of Medically Assisted Severe Hypoglycemia (MASH) During the Adjustment Period	Type 1 Diabetes	1.8	Incidence (%)
Incidence of Medically Assisted Severe Hypoglycemia (MASH) During the Adjustment Period	Type 2 Diabetes	0.4	Incidence (%)

1 to 10 of 24Source ClinicalTrials.gov

See all 24 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Type 1 Diabetes	766
Overall Study	STARTED	Type 2 Diabetes	531
Overall Study	COMPLETED	Type 1 Diabetes	541
Overall Study	COMPLETED	Type 2 Diabetes	364
Overall Study	NOT COMPLETED	Type 1 Diabetes	225
Overall Study	NOT COMPLETED	Type 2 Diabetes	167

Source ClinicalTrials.gov

Adverse events58

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
serious	Angina pectoris	Cardiac disorders	Type 1 Diabetes	1	766
serious	Angina pectoris	Cardiac disorders	Type 2 Diabetes	0	531
serious	Angina unstable	Cardiac disorders	Type 1 Diabetes	1	766
serious	Angina unstable	Cardiac disorders	Type 2 Diabetes	0	531
serious	Atrioventricular block complete	Cardiac disorders	Type 1 Diabetes	0	766
serious	Atrioventricular block complete	Cardiac disorders	Type 2 Diabetes	1	531
serious	Cardiac failure congestive	Cardiac disorders	Type 1 Diabetes	1	766
serious	Cardiac failure congestive	Cardiac disorders	Type 2 Diabetes	1	531
serious	Coronary artery disease	Cardiac disorders	Type 1 Diabetes	0	766
serious	Coronary artery disease	Cardiac disorders	Type 2 Diabetes	1	531

1 to 10 of 58Source ClinicalTrials.gov

See all 58 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Type 1 Diabetes
Total, all-cause mortality	Type 2 Diabetes
Total, other adverse events	Type 1 Diabetes	0	766
Total, other adverse events	Type 2 Diabetes	0	531
Total, serious adverse events	Type 1 Diabetes	14
Total, serious adverse events	Type 2 Diabetes	13

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
20518811	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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