Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
Conditions
Keywords
diabetes, pramlintide, Symlin, Amylin, phase 4
Brief 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.
Interventions
Subcutaneous injection prior to each major meal
Sponsors
AstraZeneca
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| Change in Body Weight From Baseline at Month 3 | 3 months | Mean change in body weight from baseline at month 3 |
| Change in Body Weight From Baseline at Month 6 | 6 months | Mean change in body weight from baseline at month 6 |
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Type 1 Diabetes Insulin using patients with Type 1 diabetes | 766 |
| Type 2 Diabetes Insulin using patients with Type 2 diabetes | 531 |
| Total | 1,297 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Administrative | 2 | 1 |
| Overall Study | Investigator decision | 13 | 10 |
| Overall Study | Lost to Follow-up | 82 | 55 |
| Overall Study | Other | 80 | 60 |
| Overall Study | Serious Adverse Event | 2 | 2 |
| Overall Study | Withdrawal of consent | 46 | 39 |
Baseline characteristics
| Characteristic | Type 1 Diabetes | Type 2 Diabetes | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 8 Participants | 0 Participants | 8 Participants |
| Age, Categorical >=65 years | 37 Participants | 125 Participants | 162 Participants |
| Age, Categorical Between 18 and 65 years | 721 Participants | 406 Participants | 1127 Participants |
| Age, Continuous | 43.2 years STANDARD_DEVIATION 13.22 | 56.9 years STANDARD_DEVIATION 11.1 | 48.8 years STANDARD_DEVIATION 14.1 |
| Body Weight | 87.21 kg STANDARD_DEVIATION 19.843 | 112.53 kg STANDARD_DEVIATION 24.79 | 97.57 kg STANDARD_DEVIATION 25.273 |
| Duration of Diabetes | 20.66 years STANDARD_DEVIATION 11.709 | 14.76 years STANDARD_DEVIATION 8.355 | 18.24 years STANDARD_DEVIATION 10.857 |
| HbA1c | 7.86 % STANDARD_DEVIATION 1.082 | 8.23 % STANDARD_DEVIATION 1.538 | 8.01 % STANDARD_DEVIATION 1.301 |
| Region of Enrollment United States | 766 participants | 531 participants | 1297 participants |
| Sex: Female, Male Female | 500 Participants | 296 Participants | 796 Participants |
| Sex: Female, Male Male | 266 Participants | 235 Participants | 501 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 766 | 0 / 531 |
| serious Total, serious adverse events | 14 / — | 13 / — |
Outcome results
Primary
Annual Event Rate of Patient-Ascertained Severe Hypoglycemia (PASH) During the Adjustment Period
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.
Time frame: 0-3 months
Population: Intent-to-Treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Type 1 Diabetes | Annual Event Rate of Patient-Ascertained Severe Hypoglycemia (PASH) During the Adjustment Period | 0.3255 Events per patient year |
| Type 2 Diabetes | Annual Event Rate of Patient-Ascertained Severe Hypoglycemia (PASH) During the Adjustment Period | 0.1941 Events per patient year |
Primary
Incidence of Patient-Ascertained Severe Hypoglycemia (PASH) During 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 adjustment period represents the initial 0-3 months of pramlintide treatment
Time frame: 0-3 months
Population: Intent-to-Treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Type 1 Diabetes | Incidence of Patient-Ascertained Severe Hypoglycemia (PASH) During the Adjustment Period | 4.8 Incidence (%) |
| Type 2 Diabetes | Incidence of Patient-Ascertained Severe Hypoglycemia (PASH) During the Adjustment Period | 2.8 Incidence (%) |
Secondary
Annual Event Rate of Medically Assisted Severe Hypoglycemia (MASH) During the Steady State Period
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.
Time frame: >3-6 months
Population: Intent-to-Treat, number analyzed includes patients still enrolled in the study during the steady-state period (3-6 months)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Type 1 Diabetes | Annual Event Rate of Medically Assisted Severe Hypoglycemia (MASH) During the Steady State Period | 0.0375 Events per patient year |
| Type 2 Diabetes | Annual Event Rate of Medically Assisted Severe Hypoglycemia (MASH) During the Steady State Period | 0.0124 Events per patient year |
Secondary
Change in Body Weight From Baseline at Month 3
Mean change in body weight from baseline at month 3
Time frame: 3 months
Population: Intent-to-Treat, patients who discontinue SYMLIN 7 or more days prior to a site visit are not included in the analyses
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Type 1 Diabetes | Change in Body Weight From Baseline at Month 3 | -1.95 kg | Standard Error 0.154 |
| Type 2 Diabetes | Change in Body Weight From Baseline at Month 3 | -1.94 kg | Standard Error 0.237 |
Secondary
Change in Body Weight From Baseline at Month 6
Mean change in body weight from baseline at month 6
Time frame: 6 months
Population: Intent-to-Treat, patients who discontinue SYMLIN 7 or more days prior to a site visit are not included in the analyses
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Type 1 Diabetes | Change in Body Weight From Baseline at Month 6 | -2.77 kg | Standard Error 0.246 |
| Type 2 Diabetes | Change in Body Weight From Baseline at Month 6 | -1.98 kg | Standard Error 0.322 |
Secondary
Change in HbA1c From Baseline at Month 3
Change in HbA1c from baseline at month 3. The HbA1c test measures the percent of glycosylated hemoglobin in the blood.
Time frame: 3 months
Population: Intent-to-Treat, patients who discontinue SYMLIN 7 or more days prior to a site visit are not included in the analyses
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Type 1 Diabetes | Change in HbA1c From Baseline at Month 3 | -0.12 percent | Standard Error 0.037 |
| Type 2 Diabetes | Change in HbA1c From Baseline at Month 3 | -0.33 percent | Standard Error 0.056 |
Secondary
Change in HbA1c From Baseline at Month 6
Change in HbA1c from baseline at month 6. The HbA1c test measures the percent of glycosylated hemoglobin in the blood.
Time frame: 6 months
Population: Intent-to-Treat, patients who discontinue SYMLIN 7 or more days prior to a site visit are not included in the analyses
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Type 1 Diabetes | Change in HbA1c From Baseline at Month 6 | -0.26 percent | Standard Error 0.046 |
| Type 2 Diabetes | Change in HbA1c From Baseline at Month 6 | -0.44 percent | Standard Error 0.071 |
Secondary
Incidence of Medically Assisted Severe Hypoglycemia (MASH) During 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. The adjustment period represents the initial 0-3 months of pramlintide treatment
Time frame: 0-3 months
Population: Intent-to-Treat.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Type 1 Diabetes | Incidence of Medically Assisted Severe Hypoglycemia (MASH) During the Adjustment Period | 1.8 Incidence (%) |
| Type 2 Diabetes | Incidence of Medically Assisted Severe Hypoglycemia (MASH) During the Adjustment Period | 0.4 Incidence (%) |
Secondary
Incidence of Medically Assisted Severe Hypoglycemia (MASH) During the Steady State 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.
Time frame: >3-6 months
Population: Intent-to-Treat, number analyzed includes patients still enrolled in the study during the steady-state period (3-6 months)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Type 1 Diabetes | Incidence of Medically Assisted Severe Hypoglycemia (MASH) During the Steady State Period | 0.8 Incidence (%) |
| Type 2 Diabetes | Incidence of Medically Assisted Severe Hypoglycemia (MASH) During the Steady State Period | 0.3 Incidence (%) |
Secondary
The Annual Event Rate of Medically Assisted Severe Hypoglycemia (MASH) During the Adjustment Period
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.
Time frame: 0-3 months
Population: Intent-to-Treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Type 1 Diabetes | The Annual Event Rate of Medically Assisted Severe Hypoglycemia (MASH) During the Adjustment Period | 0.0996 Events per patient year |
| Type 2 Diabetes | The Annual Event Rate of Medically Assisted Severe Hypoglycemia (MASH) During the Adjustment Period | 0.0185 Events per patient year |
Secondary
The Annual Event Rate of Patient-Ascertained Severe Hypoglycemia (PASH) During the Steady State Period
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.
Time frame: >3-6 months
Population: Intent-to-Treat, number analyzed includes patients still enrolled in the study during the steady-state period (3-6 months)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Type 1 Diabetes | The Annual Event Rate of Patient-Ascertained Severe Hypoglycemia (PASH) During the Steady State Period | 0.0844 Events per patient year |
| Type 2 Diabetes | The Annual Event Rate of Patient-Ascertained Severe Hypoglycemia (PASH) During the Steady State Period | 0.0248 Events per patient year |
Secondary
The Incidence of Patient-Ascertained Severe Hypoglycemia (PASH) During the Steady State 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.
Time frame: >3-6 months
Population: Intent-to-Treat, number analyzed includes patients still enrolled in the study during the steady-state period (3-6 months)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Type 1 Diabetes | The Incidence of Patient-Ascertained Severe Hypoglycemia (PASH) During the Steady State Period | 1.8 Incidence (%) |
| Type 2 Diabetes | The Incidence of Patient-Ascertained Severe Hypoglycemia (PASH) During the Steady State Period | 0.3 Incidence (%) |