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| Name | Class |
|---|---|
| Juvenile Diabetes Research Foundation | OTHER |
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This study is designed to investigate the clinical efficacy and safety of pramlintide co-administered as a fixed-dose ratio with basal-bolus SC insulin, delivered simultaneously via 2 separate pumps, in subjects with type 1 diabetes who are failing to achieve the desired level of glycemic control using insulin therapy.
Potentially eligible subjects with Type 1 diabetes mellitus who are treated with with a basal-bolus insulin regimen through multiple daily injections or insulin pump at a total daily insulin dose ≤60 U, will be eligible. Visit 1 is approximately 3-6 weeks prior to randomization. Given some variability in HbA1c and C-peptide assays, re-testing for HbA1c and C-peptide can be performed within 18 days from the initial visit. Visit 2 is approximately 2-5 weeks prior to randomization. Subjects are on lispro insulin throughout study except during Visit 4 and Visit 5, the domicile 24 hr treatment period, when they are switched to regular insulin U-100.
Screen failed patients may be re-screened for inclusion in the study, as long as re-screening takes place at least 3 months after the original screening visit. If a subject is re-screened, he/she must continue to meet all inclusion/exclusion criteria. All study procedures of initial Visit 1 must be repeated at the re-screening visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pramlintide acetate & regular insulin | Experimental | Pramlintide will be adiministered by sc infusion at a concentration of 1000ug/mL |
|
| Placebo and regular insulin | Placebo Comparator | Placebo is similar sterile solution without pramlintide. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pramlintide acetate | Drug | Pramlintide acetate administered by a separate pump |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of Pramlintide by Measurement of 24-hour Tissue Mean Weighted Glucose (MWG) Obtained With Continuous Glucose Monitoring (CGM) | 24-hour MWG mg/dL, defined as total area under the 24-hour tissue glucose curve obtained with CGM, divided by actual time span in the 24-hour period. | 24 h |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of Pramlintide by Measurement of Absolute Plasma Glucose Area Under the Plasma Concentration-time Curve (AUC) Following Lunch | Absolute postprandial plasma glucose AUC was measured for the first 3 hours (AUC0-3h) following lunch based on sample availability. (Sample times: 20 hours [lunch], 20 hours 45 min, 21 hours, 23 hours, 24 hours). | 3 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Ohman, MD | Medical Director AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Chula Vista | California | 91911 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30213882 | Derived | Riddle MC, Nahra R, Han J, Castle J, Hanavan K, Hompesch M, Huffman D, Strange P, Ohman P. Control of Postprandial Hyperglycemia in Type 1 Diabetes by 24-Hour Fixed-Dose Coadministration of Pramlintide and Regular Human Insulin: A Randomized, Two-Way Crossover Study. Diabetes Care. 2018 Nov;41(11):2346-2352. doi: 10.2337/dc18-1091. Epub 2018 Sep 13. |
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Eligible study subjects were males and females, aged ≥18 years and ≤70 years at the time of screening with a prior diagnosis of type 1 diabetes mellitus (T1DM) and an HbA1c value of ≥7.2% and ≤9.0% at screening.
The first subject was enrolled in the study (at Visit 2) on 27 August 2015. A total of 79 subjects were screened and 34 subjects were randomized at 3 sites in the United States. One additional subject was randomized in error and was discontinued prior to receiving any study medication. The last subject completed the study on 05 August 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pramlintide First, Then Placebo | (Treatment Sequence A) |
| FG001 | Placebo First, Then Pramlintide | (Treatment Sequence B) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| |||||||||||||||||||||
| Period 2 |
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Safety Analysis Set: All randomized subjects receiving any infused study treatment. Subjects were analyzed according to the treatment sequence they received.
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| ID | Title | Description |
|---|---|---|
| BG000 | Pramlintide First, Then Placebo | (Treatment Sequence A) - Safety Analysis Set |
| BG001 | Placebo First, Then Pramlintide | (Treatment Sequence B) - Safety Analysis Set |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Safety Analysis Set: All randomized subjects receiving any infused study treatment. Subjects were analyzed according to the treatment sequence they received. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Efficacy of Pramlintide by Measurement of 24-hour Tissue Mean Weighted Glucose (MWG) Obtained With Continuous Glucose Monitoring (CGM) | 24-hour MWG mg/dL, defined as total area under the 24-hour tissue glucose curve obtained with CGM, divided by actual time span in the 24-hour period. | Full Analysis Set: Of the 33 correctly randomized subjects, 26 (76.5%) had at least 1 efficacy assessment available from each of the 2 crossover periods and were included in the Full Analysis Set. | Posted | Least Squares Mean | Standard Error | mg/dL | 24 h |
|
Over two 24-hour treatment periods with a 2-week washout period between periods.
This was a crossover study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo & Regular Insulin | Placebo was similar sterile solution without pramlintide |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v.19.0 | Systematic Assessment |
Due to the unavailability of the pramlintide assay, no data are presented for pramlintide PK parameters, and changes in pramlintide concentration could not be related to changes in insulin, plasma glucose, glucagon, or triglycerides.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Peter Ohman | AstraZeneca | +1 (301) 398-0120 | Peter.Ohman@astrazeneca.com |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C105254 | pramlintide |
| D007328 | Insulin |
| ID | Term |
|---|---|
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Placebo | Drug | Placebo administered by separate pump |
|
| Lispro insulin U-100 | Drug | Subjects will be stabilized on a separate insulin pump and administered lispro insulin throughout the study, except during both inpatient treatment periods (Visit 4 and Visit 5) |
|
|
| Regular insulin U-100 | Drug | Use during two in-patient treatment periods (visits 4 and 5) and administered by separate pump |
|
|
| Efficacy of Pramlintide by Measurement of Absolute Plasma Glucose Area Under the Plasma Concentration-time Curve (AUC) Following Dinner | Absolute postprandial plasma glucose AUC (AUC0-2h) was measured for the first 2 hours following dinner based on sample availability. (Sample times: 2 hours [dinner], 2 hours 45 min, 3 hours, 4 hours). | 2 hours |
| Efficacy of Pramlintide by Measurement of Absolute Plasma Glucose Area Under the Plasma Concentration-time Curve (AUC) Following Breakfast | Absolute postprandial plasma glucose AUC (AUC0-2h) was measured for the first 2 hours following breakfast based on sample availability. (Sample times: 16 hours [breakfast], 16 hours 45 min, 17 hours, 18 hours). | 2 hours |
| Efficacy of Pramlintide by Measurement of Incremental 24-hour Tissue Glucose Area Under the Plasma Concentration-time Curve (AUC) Obtained With Continuous Glucose Monitoring (CGM) | Incremental (i.e., baseline-corrected) area under the 24-hour tissue glucose concentration curve (AUC0-24h) measured by continuous glucose monitoring (CGM) with a pre-test, non-fasting tissue glucose value as baseline. (Sample times: 0, 30 min, 2 hours [dinner], 2 hours 45 min, 3 hours, 4 hours, 9 hours, 12 hours, 14 hours, 16 hours [breakfast], 16 hours 45 min, 17 hours, 18 hours, 20 hours [lunch], 20 hours 45 min, 21 hours, 23 hours, 24 hours). | 24 h |
| Efficacy of Pramlintide by Measurement of Absolute 24-hour Plasma Glucose Area Under the Plasma Concentration-time Curve (AUC) | Absolute mean area under the 24-hour plasma glucose concentration curve, measured as total area under the curve (0 to 24 hours). (Sample times: 0, 30 min, 2 hours [dinner], 2 hours 45 min, 3 hours, 4 hours, 9 hours, 12 hours, 14 hours, 16 hours [breakfast], 16 hours 45 min, 17 hours, 18 hours, 20 hours [lunch], 20 hours 45 min, 21 hours, 23 hours, 24 hours). | 24 h |
| Efficacy of Pramlintide by Measurement of Incremental 24-hour Plasma Glucose Area Under the Plasma Concentration-time Curve (AUC) | Incremental (i.e., baseline-corrected) mean area under the 24-hour plasma glucose concentration curve, measured as total area under the curve (0 to 24 hours). (Sample times: 0, 30 min, 2 hours [dinner], 2 hours 45 min, 3 hours, 4 hours, 9 hours, 12 hours, 14 hours, 16 hours [breakfast], 16 hours 45 min, 17 hours, 18 hours, 20 hours [lunch], 20 hours 45 min, 21 hours, 23 hours, 24 hours). | 24 hours |
| Efficacy of Pramlintide Measured by Percent Time Spent in the Range of >70 mg/dL to <180 mg/dL Tissue Glucose Obtained With Continuous Glucose Monitoring (CGM) | Percent time spent in the normoglycemic range of tissue glucose concentrations between >70 mg/dL and <180 mg/dL, measured by CGM. (Sample times: 0, 30 min, 2 hours [dinner], 2 hours 45 min, 3 hours, 4 hours, 9 hours, 12 hours, 14 hours, 16 hours [breakfast], 16 hours 45 min, 17 hours, 18 hours, 20 hours [lunch], 20 hours 45 min, 21 hours, 23 hours, 24 hours). | 24 h |
| Efficacy of Pramlintide by Measurement of Absolute 24-hour Plasma Glucagon Area Under the Plasma Concentration-time Curve (AUC) | Absolute mean area under the 24-hour plasma glucagon concentration curve, measured as total area under the curve (total AUC0-24). (Sample times: 0, 30 min, 2 hours [dinner], 2 hours 45 min, 3 hours, 4 hours, 9 hours, 12 hours, 14 hours, 16 hours [breakfast], 16 hours 45 min, 17 hours, 18 hours, 20 hours [lunch], 20 hours 45 min, 21 hours, 23 hours, 24 hours). | 24 h |
| Efficacy of Pramlintide by Measurement of Incremental 24-hour Plasma Glucagon Area Under the Plasma Concentration-time Curve (AUC) | Incremental (i.e., baseline-corrected) mean area under the 24-hour plasma glucagon concentration curve with a pre-test, non-fasting plasma glucagon value as baseline. (Sample times: 0, 30 min, 2 hours [dinner], 2 hours 45 min, 3 hours, 4 hours, 9 hours, 12 hours, 14 hours, 16 hours [breakfast], 16 hours 45 min, 17 hours, 18 hours, 20 hours [lunch], 20 hours 45 min, 21 hours, 23 hours, 24 hours). | 24 h |
| Fasting Plasma Glucose Concentration | Fasting plasma glucose concentration at 0600 hours (6:00 AM) | 12 hours after dinner meal |
| Pharmacokinetics of Insulin as Demonstrated by 24-hour Plasma Insulin Area Under the Plasma Concentration-time Curve (AUC) | Mean areas under the plasma insulin concentration curves for the 24-hour periods of pramlintide and placebo administration (Sample times: -15 min, 0, 30 min, 1 hour 30 min, 2 hours [dinner], 2 hours 15 min, 2 hours 30 min, 2 hours 45 min, 3 hours, 4 hours, 5 hours, 6 hours, 9 hours, 12 hours, 15 hours, 16 hours [breakfast], 16 hours 15 min, 16 hours 30 min, 16 hours 45 min, 17 hours, 18 hours, 19 hours, 20 hours [lunch], 24 hours). | 24 hours |
| Pharmacokinetics of Insulin as Demonstrated by 24-hour Average Plasma Insulin Concentration. | Mean values of the average plasma insulin concentrations over the 24-hour periods of pramlintide and placebo administration. (Sample times: -15 min, 0, 30 min, 1 hour 30 min, 2 hours [dinner], 2 hours 15 min, 2 hours 30 min, 2 hours 45 min, 3 hours, 4 hours, 5 hours, 6 hours, 9 hours, 12 hours, 15 hours, 16 hours [breakfast], 16 hours 15 min, 16 hours 30 min, 16 hours 45 min, 17 hours, 18 hours, 19 hours, 20 hours [lunch], 24 hours). | 24 hours |
| Pharmacokinetics of Insulin as Demonstrated by Maximum Plasma Insulin Concentration | Mean maximum plasma insulin concentrations over the 24-hour periods of pramlintide and placebo administration. (Sample times: -15 min, 0, 30 min, 1 hour 30 min, 2 hours [dinner], 2 hours 15 min, 2 hours 30 min, 2 hours 45 min, 3 hours, 4 hours, 5 hours, 6 hours, 9 hours, 12 hours, 15 hours, 16 hours [breakfast], 16 hours 15 min, 16 hours 30 min, 16 hours 45 min, 17 hours, 18 hours, 19 hours, 20 hours [lunch], 24 hours). | 24 hours |
| Pharmacokinetics of Insulin as Demonstrated by the Time to the Maximum Plasma Insulin Concentration | Mean time to maximum plasma insulin concentrations over the 24-hour periods of pramlintide and placebo administration. (Sample times: -15 min, 0, 30 min, 1 hour 30 min, 2 hours [dinner], 2 hours 15 min, 2 hours 30 min, 2 hours 45 min, 3 hours, 4 hours, 5 hours, 6 hours, 9 hours, 12 hours, 15 hours, 16 hours [breakfast], 16 hours 15 min, 16 hours 30 min, 16 hours 45 min, 17 hours, 18 hours, 19 hours, 20 hours [lunch], 24 hours). | 24 hours |
| Portland |
| Oregon |
| 97239 |
| United States |
| Research Site | Chattanooga | Tennessee | 37411 | United States |
| Adverse Event |
|
| Subject decision |
|
| NOT COMPLETED |
|
|
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | Safety Analysis Set: All randomized subjects receiving any infused study treatment. Subjects were analyzed according to the treatment sequence they received. | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Safety Analysis Set: All randomized subjects receiving any infused study treatment. Subjects were analyzed according to the treatment sequence they received. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Safety Analysis Set: All randomized subjects receiving any infused study treatment. Subjects were analyzed according to the treatment sequence they received. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Safety Analysis Set: All randomized subjects receiving any infused study treatment. Subjects were analyzed according to the treatment sequence they received. | Count of Participants | Participants |
|
| Weight | Safety Analysis Set: All randomized subjects receiving any infused study treatment. Subjects were analyzed according to the treatment sequence they received. | Mean | Standard Deviation | kg |
|
| Height | Safety Analysis Set: All randomized subjects receiving any infused study treatment. Subjects were analyzed according to the treatment sequence they received. | Mean | Standard Deviation | cm |
|
| Body Mass Index | Safety Analysis Set: All randomized subjects receiving any infused study treatment. Subjects were analyzed according to the treatment sequence they received. | Mean | Standard Deviation | kg/m^2 |
|
| Duration of Diabetes | Safety Analysis Set: All randomized subjects receiving any infused study treatment. Subjects were analyzed according to the treatment sequence they received. | Mean | Standard Deviation | Years |
|
| Current Administration of Insulin | Subject's usual method of insulin administration - either multiple daily injections (MDI) or continuous subcutaneous infusion of insulin (CSII), or both. | Safety Analysis Set: All randomized subjects receiving any infused study treatment. Subjects were analyzed according to the treatment sequence they received. | Count of Participants | Participants |
|
| Renal Status Category | Safety Analysis Set: All randomized subjects receiving any infused study treatment. Subjects were analyzed according to the treatment sequence they received. | Count of Participants | Participants |
|
| Baseline Fasting Glucose | Safety Analysis Set: All randomized subjects receiving any infused study treatment. Subjects were analyzed according to the treatment sequence they received. | Mean | Standard Deviation | mmol/L |
|
| Baseline A1c | Safety Analysis Set: All randomized subjects receiving any infused study treatment. Subjects were analyzed according to the treatment sequence they received. | Mean | Standard Deviation | % |
|
| Baseline C-peptide | Safety Analysis Set: All randomized subjects receiving any infused study treatment. Subjects were analyzed according to the treatment sequence they received. | Mean | Standard Deviation | nmol/L |
|
| Baseline Insulin | Safety Analysis Set: All randomized subjects receiving any infused study treatment. Subjects were analyzed according to the treatment sequence they received. | Mean | Standard Deviation | U/day |
|
Pramlintide was administered by sc infusion at a concentration of 1000ug/ml
|
|
|
| Secondary | Efficacy of Pramlintide by Measurement of Absolute Plasma Glucose Area Under the Plasma Concentration-time Curve (AUC) Following Lunch | Absolute postprandial plasma glucose AUC was measured for the first 3 hours (AUC0-3h) following lunch based on sample availability. (Sample times: 20 hours [lunch], 20 hours 45 min, 21 hours, 23 hours, 24 hours). | Pharmacokinetic/Pharmacodynamic (PK/PD) Analysis Set: Of the 33 correctly randomized subjects, 26 (76.5%) subjects received at least 1 dose of pramlintide and had evaluable PD data and were, therefore, included in the PK/PD Analysis Set. | Posted | Least Squares Mean | 95% Confidence Interval | mmol/L*h | 3 hours |
|
|
|
|
| Secondary | Efficacy of Pramlintide by Measurement of Absolute Plasma Glucose Area Under the Plasma Concentration-time Curve (AUC) Following Dinner | Absolute postprandial plasma glucose AUC (AUC0-2h) was measured for the first 2 hours following dinner based on sample availability. (Sample times: 2 hours [dinner], 2 hours 45 min, 3 hours, 4 hours). | Pharmacokinetic/Pharmacodynamic (PK/PD) Analysis Set: Of the 33 correctly randomized subjects, 26 (76.5%) subjects received at least 1 dose of pramlintide and had evaluable PD data and were, therefore, included in the PK/PD Analysis Set. | Posted | Least Squares Mean | 95% Confidence Interval | mmol/L*h | 2 hours |
|
|
|
|
| Secondary | Efficacy of Pramlintide by Measurement of Absolute Plasma Glucose Area Under the Plasma Concentration-time Curve (AUC) Following Breakfast | Absolute postprandial plasma glucose AUC (AUC0-2h) was measured for the first 2 hours following breakfast based on sample availability. (Sample times: 16 hours [breakfast], 16 hours 45 min, 17 hours, 18 hours). | Pharmacokinetic/Pharmacodynamic (PK/PD) Analysis Set: Of the 33 correctly randomized subjects, 26 (76.5%) subjects received at least 1 dose of pramlintide and had evaluable PD data and were, therefore, included in the PK/PD Analysis Set. | Posted | Least Squares Mean | 95% Confidence Interval | mmol/L*h | 2 hours |
|
|
|
|
| Secondary | Efficacy of Pramlintide by Measurement of Incremental 24-hour Tissue Glucose Area Under the Plasma Concentration-time Curve (AUC) Obtained With Continuous Glucose Monitoring (CGM) | Incremental (i.e., baseline-corrected) area under the 24-hour tissue glucose concentration curve (AUC0-24h) measured by continuous glucose monitoring (CGM) with a pre-test, non-fasting tissue glucose value as baseline. (Sample times: 0, 30 min, 2 hours [dinner], 2 hours 45 min, 3 hours, 4 hours, 9 hours, 12 hours, 14 hours, 16 hours [breakfast], 16 hours 45 min, 17 hours, 18 hours, 20 hours [lunch], 20 hours 45 min, 21 hours, 23 hours, 24 hours). | Full Analysis Set: Of the 33 correctly randomized subjects, 26 (76.5%) had at least 1 efficacy assessment available from each of the 2 crossover periods and were included in the Full Analysis Set, | Posted | Least Squares Mean | Standard Error | mg/dL*min | 24 h |
|
|
|
|
| Secondary | Efficacy of Pramlintide by Measurement of Absolute 24-hour Plasma Glucose Area Under the Plasma Concentration-time Curve (AUC) | Absolute mean area under the 24-hour plasma glucose concentration curve, measured as total area under the curve (0 to 24 hours). (Sample times: 0, 30 min, 2 hours [dinner], 2 hours 45 min, 3 hours, 4 hours, 9 hours, 12 hours, 14 hours, 16 hours [breakfast], 16 hours 45 min, 17 hours, 18 hours, 20 hours [lunch], 20 hours 45 min, 21 hours, 23 hours, 24 hours). | Pharmacokinetic/Pharmacodynamic (PK/PD) Analysis Set: Of the 33 correctly randomized subjects, 26 (76.5%) subjects received at least 1 dose of pramlintide and had evaluable PD data and were, therefore, included in the PK/PD Analysis Set. | Posted | Least Squares Mean | 95% Confidence Interval | mmol/L*h | 24 h |
|
|
|
|
| Secondary | Efficacy of Pramlintide by Measurement of Incremental 24-hour Plasma Glucose Area Under the Plasma Concentration-time Curve (AUC) | Incremental (i.e., baseline-corrected) mean area under the 24-hour plasma glucose concentration curve, measured as total area under the curve (0 to 24 hours). (Sample times: 0, 30 min, 2 hours [dinner], 2 hours 45 min, 3 hours, 4 hours, 9 hours, 12 hours, 14 hours, 16 hours [breakfast], 16 hours 45 min, 17 hours, 18 hours, 20 hours [lunch], 20 hours 45 min, 21 hours, 23 hours, 24 hours). | Pharmacokinetic/Pharmacodynamic (PK/PD) Analysis Set: Of the 33 correctly randomized subjects, 26 (76.5%) subjects received at least 1 dose of pramlintide and had evaluable PD data and were, therefore, included in the PK/PD Analysis Set. | Posted | Mean | Standard Deviation | mmol/L*h | 24 hours |
|
|
|
| Secondary | Efficacy of Pramlintide Measured by Percent Time Spent in the Range of >70 mg/dL to <180 mg/dL Tissue Glucose Obtained With Continuous Glucose Monitoring (CGM) | Percent time spent in the normoglycemic range of tissue glucose concentrations between >70 mg/dL and <180 mg/dL, measured by CGM. (Sample times: 0, 30 min, 2 hours [dinner], 2 hours 45 min, 3 hours, 4 hours, 9 hours, 12 hours, 14 hours, 16 hours [breakfast], 16 hours 45 min, 17 hours, 18 hours, 20 hours [lunch], 20 hours 45 min, 21 hours, 23 hours, 24 hours). | Full Analysis Set:Of the 33 correctly randomized subjects, 26 (76.5%) had at least 1 efficacy assessment available from each of the 2 crossover periods and were included in the Full Analysis Set. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage of time | 24 h |
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|
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| Secondary | Efficacy of Pramlintide by Measurement of Absolute 24-hour Plasma Glucagon Area Under the Plasma Concentration-time Curve (AUC) | Absolute mean area under the 24-hour plasma glucagon concentration curve, measured as total area under the curve (total AUC0-24). (Sample times: 0, 30 min, 2 hours [dinner], 2 hours 45 min, 3 hours, 4 hours, 9 hours, 12 hours, 14 hours, 16 hours [breakfast], 16 hours 45 min, 17 hours, 18 hours, 20 hours [lunch], 20 hours 45 min, 21 hours, 23 hours, 24 hours). | Pharmacokinetic/Pharmacodynamic (PK/PD) Analysis Set: Of the 33 correctly randomized subjects, 26 (76.5%) subjects received at least 1 dose of pramlintide and had evaluable PD data and were, therefore, included in the PK/PD Analysis Set. | Posted | Least Squares Mean | 95% Confidence Interval | h*pmol/L | 24 h |
|
|
|
|
| Secondary | Efficacy of Pramlintide by Measurement of Incremental 24-hour Plasma Glucagon Area Under the Plasma Concentration-time Curve (AUC) | Incremental (i.e., baseline-corrected) mean area under the 24-hour plasma glucagon concentration curve with a pre-test, non-fasting plasma glucagon value as baseline. (Sample times: 0, 30 min, 2 hours [dinner], 2 hours 45 min, 3 hours, 4 hours, 9 hours, 12 hours, 14 hours, 16 hours [breakfast], 16 hours 45 min, 17 hours, 18 hours, 20 hours [lunch], 20 hours 45 min, 21 hours, 23 hours, 24 hours). | Pharmacokinetic/Pharmacodynamic (PK/PD) Analysis Set: Of the 33 correctly randomized subjects, 26 (76.5%) subjects received at least 1 dose of pramlintide and had evaluable PD data and were, therefore, included in the PK/PD Analysis Set. | Posted | Mean | Standard Deviation | pmol/L*h | 24 h |
|
|
|
| Secondary | Fasting Plasma Glucose Concentration | Fasting plasma glucose concentration at 0600 hours (6:00 AM) | Pharmacokinetic/Pharmacodynamic (PK/PD) Analysis Set: Of the 33 correctly randomized subjects, 26 (76.5%) subjects received at least 1 dose of pramlintide and had evaluable PD data and were, therefore, included in the PK/PD Analysis Set. | Posted | Least Squares Mean | 95% Confidence Interval | mmol/L | 12 hours after dinner meal |
|
|
|
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| Secondary | Pharmacokinetics of Insulin as Demonstrated by 24-hour Plasma Insulin Area Under the Plasma Concentration-time Curve (AUC) | Mean areas under the plasma insulin concentration curves for the 24-hour periods of pramlintide and placebo administration (Sample times: -15 min, 0, 30 min, 1 hour 30 min, 2 hours [dinner], 2 hours 15 min, 2 hours 30 min, 2 hours 45 min, 3 hours, 4 hours, 5 hours, 6 hours, 9 hours, 12 hours, 15 hours, 16 hours [breakfast], 16 hours 15 min, 16 hours 30 min, 16 hours 45 min, 17 hours, 18 hours, 19 hours, 20 hours [lunch], 24 hours). | Pharmacokinetic/Pharmacodynamic (PK/PD) Analysis Set: Of the 33 correctly randomized subjects, 26 (76.5%) subjects received at least 1 dose of pramlintide and had evaluable PD data and were, therefore, included in the PK/PD Analysis Set. | Posted | Mean | Standard Deviation | mU/L*h | 24 hours |
|
|
|
| Secondary | Pharmacokinetics of Insulin as Demonstrated by 24-hour Average Plasma Insulin Concentration. | Mean values of the average plasma insulin concentrations over the 24-hour periods of pramlintide and placebo administration. (Sample times: -15 min, 0, 30 min, 1 hour 30 min, 2 hours [dinner], 2 hours 15 min, 2 hours 30 min, 2 hours 45 min, 3 hours, 4 hours, 5 hours, 6 hours, 9 hours, 12 hours, 15 hours, 16 hours [breakfast], 16 hours 15 min, 16 hours 30 min, 16 hours 45 min, 17 hours, 18 hours, 19 hours, 20 hours [lunch], 24 hours). | Pharmacokinetic/Pharmacodynamic (PK/PD) Analysis Set: Of the 33 correctly randomized subjects, 26 (76.5%) subjects received at least 1 dose of pramlintide and had evaluable PD data and were, therefore, included in the PK/PD Analysis Set. | Posted | Mean | Standard Deviation | mIU/L | 24 hours |
|
|
|
| Secondary | Pharmacokinetics of Insulin as Demonstrated by Maximum Plasma Insulin Concentration | Mean maximum plasma insulin concentrations over the 24-hour periods of pramlintide and placebo administration. (Sample times: -15 min, 0, 30 min, 1 hour 30 min, 2 hours [dinner], 2 hours 15 min, 2 hours 30 min, 2 hours 45 min, 3 hours, 4 hours, 5 hours, 6 hours, 9 hours, 12 hours, 15 hours, 16 hours [breakfast], 16 hours 15 min, 16 hours 30 min, 16 hours 45 min, 17 hours, 18 hours, 19 hours, 20 hours [lunch], 24 hours). | Pharmacokinetic/Pharmacodynamic (PK/PD) Analysis Set: Of the 33 correctly randomized subjects, 26 (76.5%) subjects received at least 1 dose of pramlintide and had evaluable PD data and were, therefore, included in the PK/PD Analysis Set. | Posted | Mean | Standard Deviation | mIU/L | 24 hours |
|
|
|
| Secondary | Pharmacokinetics of Insulin as Demonstrated by the Time to the Maximum Plasma Insulin Concentration | Mean time to maximum plasma insulin concentrations over the 24-hour periods of pramlintide and placebo administration. (Sample times: -15 min, 0, 30 min, 1 hour 30 min, 2 hours [dinner], 2 hours 15 min, 2 hours 30 min, 2 hours 45 min, 3 hours, 4 hours, 5 hours, 6 hours, 9 hours, 12 hours, 15 hours, 16 hours [breakfast], 16 hours 15 min, 16 hours 30 min, 16 hours 45 min, 17 hours, 18 hours, 19 hours, 20 hours [lunch], 24 hours). | Pharmacokinetic/Pharmacodynamic (PK/PD) Analysis Set: Of the 33 correctly randomized subjects, 26 (76.5%) subjects received at least 1 dose of pramlintide and had evaluable PD data and were, therefore, included in the PK/PD Analysis Set. | Posted | Mean | Standard Deviation | h | 24 hours |
|
|
|
| 0 |
| 28 |
| 9 |
| 28 |
| EG001 | Pramlintide & Regular Insulin | Pramlintide was administered by sc infusion at a concentration of 1000ug/ml | 0 | 32 | 22 | 32 |
| Vomiting | Gastrointestinal disorders | MedDRA v.19.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA v.19.0 | Systematic Assessment |
|
| Cardiovascular disorder | Cardiac disorders | MedDRA v.19.0 | Systematic Assessment |
|
| Vitreous Detachment | Eye disorders | MedDRA v.19.0 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA v.19.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA v.19.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA v.19.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA v.19.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA v.19.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA v.19.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA v.19.0 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA v.19.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v.19.0 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA v.19.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA v.19.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA v.19.0 | Systematic Assessment |
|
| Irritability | Psychiatric disorders | MedDRA v.19.0 | Systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v.19.0 | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA v.19.0 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA v.19.0 | Systematic Assessment |
|
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA v.19.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v.19.0 | Systematic Assessment |
|
| Pruritus allergic | Skin and subcutaneous tissue disorders | MedDRA v.19.0 | Systematic Assessment |
|
| Scab | Skin and subcutaneous tissue disorders | MedDRA v.19.0 | Systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA v.19.0 | Systematic Assessment |
|
Not provided
Not provided
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|