| Outcome Measures: |
Primary: Percent Change From Baseline in Plasma Glucose Area Under the Concentration Time-curve From Time 0 to 4 Hours (AUC0-4 Hrs) as Measured by Mixed-meal Tolerance Test (MMTT) to Day 32, The MMTT involved the consumption of a standardised liquid meal (a nutritional supplement containing the components of fat, carbohydrate, and protein, which make up a standard MMTT) within 15 minutes, and timed serial blood samples obtained for measurement of glucose and parameters related to glucose metabolism through 240 minutes after consumption of the standardized meal (with no additional food intake during this time)., Zero minutes before and 15, 30, 45, 60, 90, 120, 180, and 240 minutes after consumption of the standardised meal on Day -5 (Baseline) and Day 32 | Secondary: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs), 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., Day 1 through Day 60|Number of Participants With Abnormal Vital Signs Reported as TEAEs, Number of participants with abnormal vital signs reported as TEAEs is reported. Vital sign measurements were obtained after the participant had rested in the supine position for at least 10 minutes at the recording time. Abnormal vital signs is defined as any abnormal finding in the vital sign parameters (blood pressure, pulse rate, body temperature, and respiratory rate)., Day 1 through Day 60|Change From Baseline in Postural Blood Pressure, The change difference is the change from Day 1 to Day 32 in the difference between systolic blood pressure (SBP) or diastolic blood pressure (DBP) values in standing and supine positions. For this outcome measure, participants with difference (standing-supine) in DBP or SBP on Day 1 and Day 32 were analyzed. For few participants either DBP or SBP was recorded eg, standing DBP was not recorded on Day 1 for 2 participants in Placebo arm and 1 participant in MEDI0382 arm; standing SBP was not recorded on Day 32 for a participant in the Placebo arm., Baseline (Day 1) through Day 32|Number of Participants With Abnormal Electrocardiograms (ECGs) Reported as TEAEs, Number of participants with abnormal ECGs reported as TEAEs is reported. Abnormal ECGs is defined as any abnormal findings in heart rate, RR interval, PR interval, QRS, axis, ST-T morphology, and QT intervals from the primary lead of the digital 12-lead ECG., Day 1 through Day 60|Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs, Number of participants with abnormal clinical laboratory parameters reported as TEAEs is reported. Abnormal clinical laboratory parameters defined as any abnormal finding during analysis of serum chemistry, hematology, and urine., Day 1 through Day 60|Number of Participants With Treatment-emergent Adverse Events of Special Interest (TEAESIs), An adverse event of special interest (AESI) was one of scientific and medical interest specific to understanding of the study drug and may require close monitoring and rapid communication by the investigator to the sponsor., Day 1 through Day 60|Change From Baseline in Mean 24-hrs Pulse Rate to the End of Each Dosing Level, Change from baseline in mean 24-hrs pulse rate to the end of each dosing levels: Day 5 for 50 μg; Day 12 for 100 μg, Day 19 for 200 μg, and Day 32 for 300 μg., Day -5 (Baseline) and on Days 5, 12, 19, and 32|Change From Baseline in Mean 24-hrs Systolic and Diastolic Blood Pressure to the End of Each Dosing Level, Change from baseline in mean 24-hrs systolic and diastolic blood pressure to the end of each dosing levels: Day 5 for 50 μg, Day 12 for 100 μg, Day 19 for 200 μg, and Day 32 for 300 μg., Day -5 (Baseline) and on Days 5, 12, 19, and 32|Change From Baseline in Haemoglobin A1c (HbA1c) to Day 32, Change from baseline in haemoglobin A1c (HbA1c) is reported., Day 1 (Baseline) and Day 32|Change From Baseline in Fasting Glucose to Day 32, Change from baseline in fasting glucose is reported., Day 1 (Baseline) and Day 32|Change From Baseline in Percentage of Time Spent Within a Target Glucose Range Over a 7-day Period to the Final Week of Treatment, Change from baseline in percentage of time spent within a target glucose range over a 7-day period to the final week of treatment is reported. Target glucose range was considered as 70 mg/dL (3.9 mmol/L) to 180 mg/dL (10 mmol/L)., Baseline (Days -8 to -2), Days 5 to 11, Days 12 to 18, Days 19 to 25, and Days 26 to 32 (final week of treatment)|Percent Change Frome Baseline in Body Weight to Day 33, Percent change from baseline in body weight is reported., Day 1 (Baseline) and Day 33|Change From Baseline in Absolute Body Weight to Day 33, Change from baseline in absolute body weight is reported., Day 1 (Baseline) and Day 33|Area Under the Plasma Concentration Time Curve Over a Dosing Duration (AUCτ) of MEDI0382 at 300 μg, Area under the plasma concentration time curve over a dosing duration (AUCτ) of MEDI0382 at 300 μg is reported., Predose and at 0.5, 1, 2, 4, 6, 8, and 24 hrs postdose on Day 32|Maximum Observed Serum Concentration (Cmax) of MEDI0382 at 300 μg, Maximum observed serum concentration (Cmax) of MEDI0382 at 300 μg is reported., Predose and at 0.5, 1, 2, 4, 6, 8, and 24 hrs postdose on Day 32|Time to Observed Maximum Serum Concentration (Tmax) of MEDI0382 at 300 μg, Time to observed maximum serum concentration (Tmax) of MEDI0382 at 300 μg is reported., Predose and at 0.5, 1, 2, 4, 6, 8, and 24 hrs postdose on Day 32|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 of MEDI0382 is reported., Days 1, 5, 12, and 19: Predose; and Day 32: Predose and at 0.5, 1, 2, 4, 6, 8, and 24 hrs postdose (Day 33)|Number of Participants With Positive Anti-drug Antibodies (ADA) Titre to MEDI0382, Number of participants with positive Anti-drug antibodies (ADA) Titre to MEDI0382 is reported., Pre-dose on Days 1, 12, and 32 and on Day 60
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| Locations: |
Research Site, Berlin, 10117, Germany|Research Site, Magdeburg, 39120, Germany|Research Site, Munster, 48145, Germany|Research Site, München, 81241, Germany|Research Site, Dundee, DD1 9SY, United Kingdom|Research Site, Edinburgh, EH16 4SA, United Kingdom|Research Site, Edinburgh, EH4 2XU, United Kingdom
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