| Outcome Measures: |
Primary: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) Through the End of the Up-titration Period, An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug., Baseline (Day -1) through Day 56 (end of Up-titration period)|Number of Participants With TEAEs and TESAEs Through the End of the Follow-up Period, An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug., Baseline (Day-1) through 28 days post last dose (end of follow-up period; approximately up to 5 months)|Number of Participants With Abnormal Electrocardiograms (ECGs) Reported as TEAEs Through the End of the Up-titration Period, Number of participants with abnormal ECGs reported as TEAEs are reported. Abnormal ECGs is defined as any abnormal findings in heart rate, RR interval, PR interval, QRS, QT intervals, and QTcF intervals from the primary lead of the digital 12-lead ECG., Baseline (Day -1) through Day 56 (end of Up-titration period)|Number of Participants With Abnormal ECGs Reported as TEAEs Through the End of the Follow-up Period, Number of participants with abnormal ECGs reported as TEAEs are reported. Abnormal ECGs is defined as any abnormal findings in heart rate, RR interval, PR interval, QRS, QT intervals, and QTcF intervals from the primary lead of the digital 12-lead ECG., Baseline (Day-1) through 28 days post last dose (end of follow-up period; approximately up to 5 months)|Number of Participants With Abnormal Vital Signs Reported as TEAEs Through the End of the Up-titration Period, Number of participants with abnormal vital signs reported as TEAEs are reported. Abnormal vital signs are defined as any abnormal finding in the vital sign parameters (blood pressure, heart rate, body temperature, and respiratory rate)., Baseline (Day -1) through Day 56 (end of Up-titration period)|Number of Participants With Abnormal Vital Signs Reported as TEAEs Through the End of the Follow-up Period, Number of participants with abnormal vital signs reported as TEAEs are reported. Abnormal vital signs are defined as any abnormal finding in the vital sign parameters (blood pressure, heart rate, body temperature, and respiratory rate)., Baseline (Day-1) through 28 days post last dose (end of follow-up period; approximately up to 5 months)|Number of Participants With Abnormal Physical Examinations Reported as TEAEs Through the End of the Up-titration Period, Number of participants with abnormal physical examinations reported as TEAEs are reported. Abnormal physical examinations findings are defined as any abnormal finding in the following body systems: immunologic/allergy; head, ears, eyes, nose, and throat; respiratory; cardiovascular; gastrointestinal; musculoskeletal; neurological psychiatric; dermatologic; hematologic/lymphatic; and, endocrine., Baseline (Day -1) through Day 56 (end of Up-titration period)|Number of Participants With Abnormal Physical Examinations Reported as TEAEs Through the End of the Follow-up Period, Number of participants with abnormal physical examinations reported as TEAEs are reported. Abnormal physical examination findings are defined as any abnormal finding in the following body systems: immunologic/allergy; head, ears, eyes, nose, and throat; respiratory; cardiovascular; gastrointestinal; musculoskeletal; neurological psychiatric; dermatologic; hematologic/lymphatic; and endocrine., Baseline (Day-1) through 28 days post last dose (end of follow-up period; approximately up to 5 months)|Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs Through the End of the Up-titration Period, Number of participants with abnormal clinical laboratory parameters reported as TEAEs are reported. Abnormal clinical laboratory parameters defined as any abnormal finding during analysis of serum chemistry, hematology, and urine., Baseline (Day -1) through Day 56 (end of Up-titration period)|Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs Through the End of the Follow-up Period, Number of participants with abnormal clinical laboratory parameters reported as TEAEs are reported. Abnormal clinical laboratory parameters defined as any abnormal finding during analysis of serum chemistry, hematology, and urine., Baseline (Day-1) through 28 days post last dose (end of follow-up period; approximately up to 5 months) | Secondary: Area Under the Plasma Concentration Time Curve Over a Dosing Interval (AUCτ) of MEDI0382, Area under the plasma concentration time curve over a dosing duration (AUCτ) of MEDI0382 is reported., Pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post dose on Days 1, 7, 14, 35, 42, 49 and 56; pre-dose on Days 22, 29, 70, 84; additional 48 and 72 hours post-dose on Day 84|Maximum Observed Serum Concentration (Cmax) of MEDI0382, Maximum observed serum concentration (Cmax) of MEDI0382 is reported., Pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post dose on Days 1, 7, 14, 35, 42, 49 and 56; pre-dose on Days 22, 29, 70, 84; additional 48 and 72 hours post-dose on Day 84|Time to Observed Maximum Serum Concentration (Tmax) of MEDI0382, Time to observed maximum serum concentration (Tmax) of MEDI0382 is reported., Pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post dose on Days 1, 7, 14, 35, 42, 49 and 56; pre-dose on Days 22, 29, 70, 84; additional 48 and 72 hours post-dose on Day 84|Trough Plasma Concentration (Ctrough) of MEDI0382, Trough concentration is the lowest concentration reached by a drug before the next dose is administered. Trough plasma concentration (Ctrough) of MEDI0382 is reported., Pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post dose on Days 1, 7, 14, 35, 42, 49 and 56; pre-dose on Days 22, 29, 70, 84; additional 48 and 72 hours post-dose on Day 84|Observed Accumulation Ratio (Ro) of MEDI0382 Calculated Using AUC, The Ro was calculated using the AUC method which account for the overall exposure measured using the Day 1 and specified time point (Day I). Ro = AUCtrough \[Day I\]/AUCtrough \[Day 1\]; where I is the specified day., Pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post dose on Days 1, 7, 14, 35, 42, 49 and 56; pre-dose on Days 22, 29, 70, 84; additional 48 and 72 hours post-dose on Day 84|Number of Participants With Positive Anti-drug Antibodies (ADA) to MEDI0382 Treatment, Number of participants with positive ADA to MEDI0382 are reported., Pre-dose (Day -2), Days 7, 14, 35, 42, 56; Day 21 of 3 week treatment extension, and 28 days post last dose (approximately 5 months)|Change From Baseline in Daily (24 Hours) Average Glucose Levels Over Time as Measured by Continuous Glucose Monitoring (CGM), Continuous glucose monitoring is a minimally invasive device applied to the skin in the upper arm that provides a measure of interstitial glucose levels every 15 minutes. Data derived from CGM was used to calculate the average glucose level over 24-hour and 7-day periods to compare the glucose lowering efficacy of each dose level. During 14 days follow-up (Day 91), last observation carried forward (LOCF) approach was used to calculate the value., Baseline (Day -1) through Day 56 (end of the up-titration period), Day 77 (end of the treatment extension period) and Day 91 (end of the follow-up period)|Change From Baseline in 7-day Average Glucose Levels Over Time as Measured by CGM, Continuous glucose monitoring is a minimally invasive device applied to the skin in the upper arm that provides a measure of interstitial glucose levels every 15 minutes. Data derived from CGM was used to calculate the average glucose level over 24-hour and 7-day periods to compare the glucose lowering efficacy of each dose level., Baseline (Days -7 to -1), Days 1-7, Days 8-14, Days 15-21, Days 22-28, Days 29-35, Days 36-42, Days 43-49, Days 50-56 of the Up-titration period, and Days 71-77 of end of the treatment extension period|Percentage Change From Baseline in Glucose Area Under Concentration Time-curve Over 4 Hours (AUC4Hrs) During a Standardized Breakfast, Lunch, and Evening Meal Over Time as Measured by CGM, Change from baseline in percentage of glucose AUC4Hrs during a standardized breakfast, lunch, and evening meal over time is reported. Continuous glucose monitoring is a minimally invasive device applied to the skin in the upper arm that provides a measure of interstitial glucose levels every 15 minutes. Data derived from CGM was used to calculate the average glucose level over 24-hour and 7-day periods to compare the glucose lowering efficacy of each dose level., Baseline (Day -1) through Day 7 (end of Week 1), Day 56 (end of the up-titration period), and Day 77 (end of the treatment extension period)|Change From Baseline in Coefficient of Variation (CV) in Glucose Over 7 Days as Measured by CGM, Continuous glucose monitoring is a minimally invasive device applied to the skin in the upper arm that provides a measure of interstitial glucose levels every 15 minutes. Data derived from CGM was used to calculate the average glucose level over 24-hour and 7-day periods to compare the glucose lowering efficacy of each dose level. Change from baseline in coefficient of variation in glucose over 7 days is reported., Baseline (Days -7 to -1), Days 1-7, Days 8-14, Days 15-21, Days 22-28, Days 29-35, Days 36-42, Days 43-49, Days 50-56 of the Up-titration period, and Days 71-77 of end of the treatment extension period|Change From Baseline in Percentage of Time Spent in Hyperglycemia, Normoglycemia, and Clinically Significant Hypoglycemia Over 24 Hours Time as Measured by CGM, Continuous glucose monitoring is a minimally invasive device applied to the skin in the upper arm that provides a measure of interstitial glucose levels every 15 minutes. Data derived from CGM was used to calculate the average glucose level over 24-hour and 7-day periods to compare the glucose lowering efficacy of each dose level. Hyperglycemia (\> 140 mg/dL), normoglycemia (70 -140 mg/dL), and clinically significant hypoglycemia (\< 54 mg/dL)., Baseline (Day -1), Days 7, 14, 21, 28, 35, 42, 49, 56 of the up-titration period, and Day77 (end of the treatment extension period)|Change From Baseline in Percentage of Time Spent in Hyperglycemia, Normoglycemia, and Clinically Significant Hypoglycemia Over 7 Days as Measured by CGM, Continuous glucose monitoring is a minimally invasive device applied to the skin in the upper arm that provides a measure of interstitial glucose levels every 15 minutes. Data derived from CGM was used to calculate the average glucose level over 24-hour and 7-day periods to compare the glucose lowering efficacy of each dose level. Hyperglycemia (\> 140 mg/dL), normoglycemia (70 -140 mg/dL), and clinically significant hypoglycemia (\< 54 mg/dL)., Baseline (Days -7 to -1), Days 1-7, Days 8-14, Days 15-21, Days 22-28, Days 29-35, Days 36-42, Days 43-49, Days 50-56 of the Up-titration period, and Days 71-77 of end of the treatment extension period|Change From Baseline in Estimated Hemoglobin A1c (HbA1c) Based on 7-day CGM Glucose Over Time, Change from baseline in estimated HbA1c based on 7-day glucose over time is reported., Baseline (Days -7 to -1), Days 1-7, Days 8-14, Days 15-21, Days 22-28, Days 29-35, Days 36-42, Days 43-49, Days 50-56 of the Up-titration period, and Days 71-77 of end of the treatment extension period|Change From Baseline in Fasting Plasma Glucose Over Time, Change from baseline in fasting plasma glucose over time is reported. During the Day 21, and Day 28, LOCF approach was used to calculate the value., Baseline (Day -1), Days 7, 14, 21, 28, 35, 42, 49, 56 of the up-titration period, and Day77 (end of the treatment extension period)|Change From Baseline in HbA1c, Change from baseline in HbA1c is reported., Baseline (Day -1) through Day 77 (end of the treatment extension period)|Absolute Change From Baseline in Body Weight, Absolute change from baseline in body weight is reported., Baseline (Day -1) through Day 56 (end of the up-titration period) and Day 77 (end of the TEP)|Percentage Change From Baseline in Body Weight, Percentage change from baseline in body weight is reported., Baseline (Day -1) through Day 56 (end of the up-titration period) and Day 77 (end of the TEP)|Absolute Change From Baseline in Body Weight to the End of Each Week of the Up-titration Period, Absolute change from baseline in body weight to the end of each week of the up-titration period is reported., Baseline (Day -1), Days 7, 14, 35, 42, 49, and 56|Percentage Change From Baseline in Body Weight to the End of Each Week of the Up-titration Period, Percentage change from baseline in body weight to the end of each week of the up-titration period is reported., Baseline (Day -1), Days 7, 14, 35, 42, 49, and 56|Percentage of Participants Achieving Greater Than 5% Body Weight Loss From Baseline to the End of the Treatment Extension Period, Percentage of participants achieving greater than 5% body weight loss from baseline is reported., Baseline (Day -1) through Day 77 (end of the treatment extension period)
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