An Observational Study Evaluating SYMLIN® (Pramlintide Acetate) Injection Use in Insulin Using Patients With Type 2 and Type 1 Diabetes
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| ClinicalTrials.gov Identifier: NCT00229658 |
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Recruitment Status :
Completed
First Posted : September 30, 2005
Results First Posted : June 24, 2009
Last Update Posted : March 25, 2015
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| Condition or disease | Intervention/treatment |
|---|---|
| Type 1 Diabetes Mellitus Type 2 Diabetes Mellitus | Drug: pramlintide acetate |
| Study Type : | Observational |
| Actual Enrollment : | 1297 participants |
| 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 |
| Study Start Date : | September 2005 |
| Actual Primary Completion Date : | May 2008 |
| Actual Study Completion Date : | May 2008 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Type 1
Patients with type 1 diabetes
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Drug: pramlintide acetate
Subcutaneous injection prior to each major meal
Other Name: Symlin |
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Type 2
Patients with type 2 diabetes
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Drug: pramlintide acetate
Subcutaneous injection prior to each major meal
Other Name: Symlin |
- 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.
- The Incidence of Patient-Ascertained Severe Hypoglycemia (PASH) During the Steady State Period [ Time Frame: >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.
- The Annual Event Rate of Patient-Ascertained Severe Hypoglycemia (PASH) During the Steady State Period [ Time Frame: >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.
- Incidence of Medically Assisted Severe Hypoglycemia (MASH) During the Adjustment Period [ Time Frame: 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
- The Annual Event Rate of Medically Assisted Severe Hypoglycemia (MASH) 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.
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 ]
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 ]
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 ]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 ]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 ]Mean change in body weight from baseline at month 3
- Change in Body Weight From Baseline at Month 6 [ Time Frame: 6 months ]Mean change in body weight from baseline at month 6
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
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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:
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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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00229658
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| Study Director: | Vice President, Medical Development, MD | Amylin Pharmaceuticals, LLC. |
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00229658 |
| Other Study ID Numbers: |
137-161 |
| First Posted: | September 30, 2005 Key Record Dates |
| Results First Posted: | June 24, 2009 |
| Last Update Posted: | March 25, 2015 |
| Last Verified: | February 2015 |
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diabetes pramlintide Symlin Amylin phase 4 |
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Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Autoimmune Diseases Immune System Diseases Pramlintide Hypoglycemic Agents Physiological Effects of Drugs |