Trial Outcomes & Findings for An Observational Study Evaluating SYMLIN® (Pramlintide Acetate) Injection Use in Insulin Using Patients With Type 2 and Type 1 Diabetes (NCT NCT00229658)
NCT ID: NCT00229658
Last Updated: 2015-03-25
Results Overview
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
COMPLETED
1297 participants
0-3 months
2015-03-25
Participant Flow
Participant milestones
| Measure |
Type 1 Diabetes
Insulin using patients with Type 1 diabetes
|
Type 2 Diabetes
Insulin using patients with Type 2 diabetes
|
|---|---|---|
|
Overall Study
STARTED
|
766
|
531
|
|
Overall Study
COMPLETED
|
541
|
364
|
|
Overall Study
NOT COMPLETED
|
225
|
167
|
Reasons for withdrawal
| Measure |
Type 1 Diabetes
Insulin using patients with Type 1 diabetes
|
Type 2 Diabetes
Insulin using patients with Type 2 diabetes
|
|---|---|---|
|
Overall Study
Administrative
|
2
|
1
|
|
Overall Study
Investigator decision
|
13
|
10
|
|
Overall Study
Other
|
80
|
60
|
|
Overall Study
Lost to Follow-up
|
82
|
55
|
|
Overall Study
Serious Adverse Event
|
2
|
2
|
|
Overall Study
Withdrawal of consent
|
46
|
39
|
Baseline Characteristics
An Observational Study Evaluating SYMLIN® (Pramlintide Acetate) Injection Use in Insulin Using Patients With Type 2 and Type 1 Diabetes
Baseline characteristics by cohort
| Measure |
Type 1 Diabetes
n=766 Participants
Insulin using patients with Type 1 diabetes
|
Type 2 Diabetes
n=531 Participants
Insulin using patients with Type 2 diabetes
|
Total
n=1297 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
8 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
721 Participants
n=5 Participants
|
406 Participants
n=7 Participants
|
1127 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
37 Participants
n=5 Participants
|
125 Participants
n=7 Participants
|
162 Participants
n=5 Participants
|
|
Age, Continuous
|
43.2 years
STANDARD_DEVIATION 13.22 • n=5 Participants
|
56.9 years
STANDARD_DEVIATION 11.10 • n=7 Participants
|
48.8 years
STANDARD_DEVIATION 14.10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
500 Participants
n=5 Participants
|
296 Participants
n=7 Participants
|
796 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
266 Participants
n=5 Participants
|
235 Participants
n=7 Participants
|
501 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
766 participants
n=5 Participants
|
531 participants
n=7 Participants
|
1297 participants
n=5 Participants
|
|
Body Weight
|
87.21 kg
STANDARD_DEVIATION 19.843 • n=5 Participants
|
112.53 kg
STANDARD_DEVIATION 24.790 • n=7 Participants
|
97.57 kg
STANDARD_DEVIATION 25.273 • n=5 Participants
|
|
Duration of Diabetes
|
20.66 years
STANDARD_DEVIATION 11.709 • n=5 Participants
|
14.76 years
STANDARD_DEVIATION 8.355 • n=7 Participants
|
18.24 years
STANDARD_DEVIATION 10.857 • n=5 Participants
|
|
HbA1c
|
7.86 %
STANDARD_DEVIATION 1.082 • n=5 Participants
|
8.23 %
STANDARD_DEVIATION 1.538 • n=7 Participants
|
8.01 %
STANDARD_DEVIATION 1.301 • n=5 Participants
|
PRIMARY outcome
Timeframe: 0-3 monthsPopulation: Intent-to-Treat
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
Outcome measures
| Measure |
Type 1 Diabetes
n=766 Participants
Insulin using patients with Type 1 diabetes
|
Type 2 Diabetes
n=531 Participants
Insulin using patients with Type 2 diabetes
|
|---|---|---|
|
Incidence of Patient-Ascertained Severe Hypoglycemia (PASH) During the Adjustment Period
|
4.8 Incidence (%)
|
2.8 Incidence (%)
|
PRIMARY outcome
Timeframe: 0-3 monthsPopulation: Intent-to-Treat
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.
Outcome measures
| Measure |
Type 1 Diabetes
n=766 Participants
Insulin using patients with Type 1 diabetes
|
Type 2 Diabetes
n=531 Participants
Insulin using patients with Type 2 diabetes
|
|---|---|---|
|
Annual Event Rate of Patient-Ascertained Severe Hypoglycemia (PASH) During the Adjustment Period
|
0.3255 Events per patient year
|
0.1941 Events per patient year
|
SECONDARY outcome
Timeframe: >3-6 monthsPopulation: Intent-to-Treat, number analyzed includes patients still enrolled in the study 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.
Outcome measures
| Measure |
Type 1 Diabetes
n=512 Participants
Insulin using patients with Type 1 diabetes
|
Type 2 Diabetes
n=387 Participants
Insulin using patients with Type 2 diabetes
|
|---|---|---|
|
The Incidence of Patient-Ascertained Severe Hypoglycemia (PASH) During the Steady State Period
|
1.8 Incidence (%)
|
0.3 Incidence (%)
|
SECONDARY outcome
Timeframe: >3-6 monthsPopulation: Intent-to-Treat, number analyzed includes patients still enrolled in the study 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.
Outcome measures
| Measure |
Type 1 Diabetes
n=512 Participants
Insulin using patients with Type 1 diabetes
|
Type 2 Diabetes
n=387 Participants
Insulin using patients with Type 2 diabetes
|
|---|---|---|
|
The Annual Event Rate of Patient-Ascertained Severe Hypoglycemia (PASH) During the Steady State Period
|
0.0844 Events per patient year
|
0.0248 Events per patient year
|
SECONDARY outcome
Timeframe: 0-3 monthsPopulation: Intent-to-Treat.
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
Outcome measures
| Measure |
Type 1 Diabetes
n=766 Participants
Insulin using patients with Type 1 diabetes
|
Type 2 Diabetes
n=531 Participants
Insulin using patients with Type 2 diabetes
|
|---|---|---|
|
Incidence of Medically Assisted Severe Hypoglycemia (MASH) During the Adjustment Period
|
1.8 Incidence (%)
|
0.4 Incidence (%)
|
SECONDARY outcome
Timeframe: 0-3 monthsPopulation: Intent-to-Treat
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.
Outcome measures
| Measure |
Type 1 Diabetes
n=766 Participants
Insulin using patients with Type 1 diabetes
|
Type 2 Diabetes
n=531 Participants
Insulin using patients with Type 2 diabetes
|
|---|---|---|
|
The Annual Event Rate of Medically Assisted Severe Hypoglycemia (MASH) During the Adjustment Period
|
0.0996 Events per patient year
|
0.0185 Events per patient year
|
SECONDARY outcome
Timeframe: >3-6 monthsPopulation: Intent-to-Treat, number analyzed includes patients still enrolled in the study 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.
Outcome measures
| Measure |
Type 1 Diabetes
n=512 Participants
Insulin using patients with Type 1 diabetes
|
Type 2 Diabetes
n=387 Participants
Insulin using patients with Type 2 diabetes
|
|---|---|---|
|
Incidence of Medically Assisted Severe Hypoglycemia (MASH) During the Steady State Period
|
0.8 Incidence (%)
|
0.3 Incidence (%)
|
SECONDARY outcome
Timeframe: >3-6 monthsPopulation: Intent-to-Treat, number analyzed includes patients still enrolled in the study 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.
Outcome measures
| Measure |
Type 1 Diabetes
n=512 Participants
Insulin using patients with Type 1 diabetes
|
Type 2 Diabetes
n=387 Participants
Insulin using patients with Type 2 diabetes
|
|---|---|---|
|
Annual Event Rate of Medically Assisted Severe Hypoglycemia (MASH) During the Steady State Period
|
0.0375 Events per patient year
|
0.0124 Events per patient year
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Intent-to-Treat, patients who discontinue SYMLIN 7 or more days prior to a site visit are not included in the analyses
Change in HbA1c from baseline at month 3. The HbA1c test measures the percent of glycosylated hemoglobin in the blood.
Outcome measures
| Measure |
Type 1 Diabetes
n=414 Participants
Insulin using patients with Type 1 diabetes
|
Type 2 Diabetes
n=371 Participants
Insulin using patients with Type 2 diabetes
|
|---|---|---|
|
Change in HbA1c From Baseline at Month 3
|
-0.12 percent
Standard Error 0.037
|
-0.33 percent
Standard Error 0.056
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Intent-to-Treat, patients who discontinue SYMLIN 7 or more days prior to a site visit are not included in the analyses
Change in HbA1c from baseline at month 6. The HbA1c test measures the percent of glycosylated hemoglobin in the blood.
Outcome measures
| Measure |
Type 1 Diabetes
n=347 Participants
Insulin using patients with Type 1 diabetes
|
Type 2 Diabetes
n=290 Participants
Insulin using patients with Type 2 diabetes
|
|---|---|---|
|
Change in HbA1c From Baseline at Month 6
|
-0.26 percent
Standard Error 0.046
|
-0.44 percent
Standard Error 0.071
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Intent-to-Treat, patients who discontinue SYMLIN 7 or more days prior to a site visit are not included in the analyses
Mean change in body weight from baseline at month 3
Outcome measures
| Measure |
Type 1 Diabetes
n=443 Participants
Insulin using patients with Type 1 diabetes
|
Type 2 Diabetes
n=370 Participants
Insulin using patients with Type 2 diabetes
|
|---|---|---|
|
Change in Body Weight From Baseline at Month 3
|
-1.95 kg
Standard Error 0.154
|
-1.94 kg
Standard Error 0.237
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Intent-to-Treat, patients who discontinue SYMLIN 7 or more days prior to a site visit are not included in the analyses
Mean change in body weight from baseline at month 6
Outcome measures
| Measure |
Type 1 Diabetes
n=364 Participants
Insulin using patients with Type 1 diabetes
|
Type 2 Diabetes
n=294 Participants
Insulin using patients with Type 2 diabetes
|
|---|---|---|
|
Change in Body Weight From Baseline at Month 6
|
-2.77 kg
Standard Error 0.246
|
-1.98 kg
Standard Error 0.322
|
Adverse Events
Type 1 Diabetes
Type 2 Diabetes
Serious adverse events
| Measure |
Type 1 Diabetes
n=766 participants at risk
Insulin using patients with Type 1 diabetes
|
Type 2 Diabetes
n=531 participants at risk
Insulin using patients with Type 2 diabetes
|
|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.13%
1/766
|
0.00%
0/531
|
|
Cardiac disorders
Angina unstable
|
0.13%
1/766
|
0.00%
0/531
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/766
|
0.19%
1/531
|
|
Cardiac disorders
Cardiac failure congestive
|
0.13%
1/766
|
0.19%
1/531
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/766
|
0.19%
1/531
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/766
|
0.19%
1/531
|
|
Gastrointestinal disorders
Pancreatitis
|
0.13%
1/766
|
0.00%
0/531
|
|
General disorders
Chest pain
|
0.00%
0/766
|
0.19%
1/531
|
|
General disorders
Hernia obstructive
|
0.00%
0/766
|
0.19%
1/531
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.13%
1/766
|
0.00%
0/531
|
|
Infections and infestations
Appendicitis
|
0.13%
1/766
|
0.00%
0/531
|
|
Infections and infestations
Cellulitis
|
0.00%
0/766
|
0.19%
1/531
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/766
|
0.19%
1/531
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/766
|
0.19%
1/531
|
|
Infections and infestations
Pneumonia
|
0.13%
1/766
|
0.00%
0/531
|
|
Infections and infestations
Sepsis
|
0.00%
0/766
|
0.38%
2/531
|
|
Infections and infestations
Urosepsis
|
0.00%
0/766
|
0.19%
1/531
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.39%
3/766
|
0.00%
0/531
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.13%
1/766
|
0.00%
0/531
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.13%
1/766
|
0.00%
0/531
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian granulosa-theca cell tumour
|
0.00%
0/766
|
0.19%
1/531
|
|
Nervous system disorders
Presyncope
|
0.13%
1/766
|
0.00%
0/531
|
|
Nervous system disorders
Syncope
|
0.13%
1/766
|
0.00%
0/531
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.00%
0/766
|
0.19%
1/531
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.13%
1/766
|
0.00%
0/531
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/766
|
0.19%
1/531
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/766
|
0.19%
1/531
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/766
|
0.19%
1/531
|
|
Vascular disorders
Deep vein thrombosis
|
0.13%
1/766
|
0.00%
0/531
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60