An Observational Study Evaluating SYMLIN® (Pramlintide Acetate) Injection Use in Insulin Using Patients With Type 2 and Type 1 Diabetes
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Type 1 Diabetes Mellitus Type 2 Diabetes Mellitus |
Drug: pramlintide acetate |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| 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 |
- Incidence of Patient-Ascertained Severe Hypoglycemia (PASH) During the Adjustment Period [ Time Frame: 0-3 months ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]
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.
- The Incidence of Patient-Ascertained Severe Hypoglycemia (PASH) During the Steady State Period [ Time Frame: >3-6 months ] [ Designated as safety issue: Yes ]
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.
- The Annual Event Rate of Patient-Ascertained Severe Hypoglycemia (PASH) During the Steady State Period [ Time Frame: >3-6 months ] [ Designated as safety issue: Yes ]
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.
- Incidence of Medically Assisted Severe Hypoglycemia (MASH) During the Adjustment Period [ Time Frame: 0-3 months ] [ Designated as safety issue: Yes ]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
- The Annual Event Rate of Medically Assisted Severe Hypoglycemia (MASH) During the Adjustment Period [ Time Frame: 0-3 months ] [ Designated as safety issue: Yes ]
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.
- Incidence of Medically Assisted Severe Hypoglycemia (MASH) During the Steady State Period [ Time Frame: >3-6 months ] [ Designated as safety issue: Yes ]
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.
- Annual Event Rate of Medically Assisted Severe Hypoglycemia (MASH) During the Steady State Period [ Time Frame: >3-6 months ] [ Designated as safety issue: Yes ]
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.
- Change in HbA1c From Baseline at Month 3 [ Time Frame: 3 months ] [ Designated as safety issue: No ]Change in HbA1c from baseline at month 3. The HbA1c test measures the percent of glycosylated hemoglobin in the blood.
- Change in HbA1c From Baseline at Month 6 [ Time Frame: 6 months ] [ Designated as safety issue: No ]Change in HbA1c from baseline at month 6. The HbA1c test measures the percent of glycosylated hemoglobin in the blood.
- Change in Body Weight From Baseline at Month 3 [ Time Frame: 3 months ] [ Designated as safety issue: No ]Mean change in body weight from baseline at month 3
- Change in Body Weight From Baseline at Month 6 [ Time Frame: 6 months ] [ Designated as safety issue: No ]Mean change in body weight from baseline at month 6
| Enrollment: | 1297 |
| Study Start Date: | September 2005 |
| Study Completion Date: | May 2008 |
| Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Type 1
Patients with type 1 diabetes
|
Drug: pramlintide acetate
Subcutaneous injection prior to each major meal
Other Name: Symlin
|
|
Type 2
Patients with type 2 diabetes
|
Drug: pramlintide acetate
Subcutaneous injection prior to each major meal
Other Name: Symlin
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00229658
Show 107 Study Locations
| Study Director: | Vice President, Medical Development, MD | Amylin Pharmaceuticals, LLC. |
More Information
No publications provided by AstraZeneca
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00229658 History of Changes |
| Other Study ID Numbers: | 137-161 |
| Study First Received: | September 28, 2005 |
| Results First Received: | May 5, 2009 |
| Last Updated: | June 4, 2014 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by AstraZeneca:
|
diabetes pramlintide Symlin Amylin phase 4 |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 1 Autoimmune Diseases Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Islet Amyloid Polypeptide |
Pramlintide Anti-Obesity Agents Appetite Depressants Central Nervous System Agents Hypoglycemic Agents Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015