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Clinical Trial Details

Trial ID: L5941
Source ID: NCT03244800
Associated Drug: Medi0382
Title: A Study to Investigate Different Doses of 0382 in Overweight and Obese Subjects With Type 2 Diabetes Mellitus.
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT03244800/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: MEDI0382|DRUG: Placebo
Outcome Measures: Primary: Cohort 1: Percent Change From Baseline in Plasma Glucose Area Under the Concentration-time Curve From Time 0 to 4 Hours (AUC0-4h) by Mixed-meal Tolerance Test (MMTT) to Day 49, The MMTT test involved the consumption of a standardised liquid meal within 5 minutes and timed serial blood samples obtained for the measurement of glucose and parameters related to glucose metabolism through 240 minutes after consumption of the standardised meal (with no additional food intake during this time). The percent change in the MMTT plasma glucose AUC 0-4h from the baseline (Day -1) to Day 49 is reported., Zero minutes before and 15, 30, 45, 60, 90, 120, 180, and 240 minutes after consumption of the standardised liquid meal|Cohort 1: Percent Change From Baseline in Body Weight to Day 50, The percent change in body weight from baseline to Day 50 is reported., Day 1 through Day 50 | Secondary: Cohort 1: Change From Baseline in Glycated Haemoglobin (HbA1c) to Day 49, The change from baseline in Glycated haemoglobin (HbA1c) to Day 49 is reported., Baseline (Day -1) through Day 49|Cohort 1: Change From Baseline in Fasting Plasma Glucose to Day 49, The changes in the fasting plasma glucose level during the study period from baseline to Day 49 is reported., Baseline (Day -1) through Day 49|Cohort 1: Change From Baseline in Body Weight to Day 50, The changes in the body weight during the study period from baseline to Day 50 is reported., Day 1 through Day 50|Cohort 1: Percentage of Participants Achieving Greater Than or Equal to 5% Body Weight Loss From Baseline to Day 50, Participants achieving greater than or equal to 5% body weight loss from baseline to Day 50 is reported., Day 1 through Day 50|Cohort 1 and Cohort 2: Percent Change From Baseline in MMTT Plasma Glucose AUC 0-4h to Day 7, The MMTT test involved the consumption of a standardised liquid meal within 5 minutes and timed serial blood samples obtained for the measurement of glucose and parameters related to glucose metabolism through 240 minutes after consumption of the standardised meal (with no additional food intake during this time). The percent change in the MMTT plasma glucose AUC 0-4h from the baseline (Day -1) evaluation to Day 7 is reported., Zero minutes before and 15, 30, 45, 60, 90, 120, 180, and 240 minutes after consumption of the standardised liquid meal|Cohort 1 and Cohort 2: 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. An 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. Treatment-emergent are the events between first doses of study drug through 7 to 14 days after the last dose of study drug (approximately 64 days)., From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)|Cohort 1 and Cohort 2: Number of Participants With Abnormal Vital Signs Reported as TEAEs, Treatment-emergent adverse events observed in participants with clinically significant vital signs abnormalities are reported. Vital sign parameters included blood pressure, heart rate, body temperature, and respiration rate., From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)|Cohort 1 and Cohort 2: Number of Participants With Abnormal Electrocardiogram Reported as TEAEs, Treatment-emergent adverse events observed in participants with clinically significant ECG abnormalities are reported., From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)|Cohort 1 and Cohort 2: Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs, An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator as medically significant was reported as an AE. Laboratory evaluations included haematology, serum chemistry, and urinalysis., From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)|Cohort 1 and Cohort 2: Number of Participants With Injection Site Erythema, The injection site reactions observed during study visits were reported. Injection site reactions included (but are not limited to) local erythema, pain, tenderness, induration, swelling, pruritus, ulceration, and pigmentation., From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)|Cohort 1: Area Under the Concentration-time Curve During the Dosing Interval (AUCt) of MEDI0382, The area under the concentration-time curve during the dosing interval of MEDI0382 is reported., Cohort 1: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 22 and 49|Cohort 2: Area Under the Concentration-time Curve During the Dosing Interval (AUCt) of MEDI0382, The area under the concentration-time curve during the dosing interval of MEDI0382 is reported., Cohort 2: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 1, 7, and 14|Cohort 1: Maximum Observed Concentration (Cmax) of MEDI0382, The maximum observed concentration of MEDI0382 is reported., Cohort 1: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 22 and 49|Cohort 2: Maximum Observed Concentration (Cmax) of MEDI0382, The maximum observed concentration of MEDI0382 is reported., Cohort 2: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 1, 7, and 14|Cohort 1: Time to Reach Maximum Observed Concentration (Tmax) of MEDI0382, The time to reach the maximum observed concentration of MEDI0382 is reported., Cohort 1: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 22 and 49|Cohort 2: Time to Reach Maximum Observed Concentration (Tmax) of MEDI0382, The time to reach the maximum observed concentration of MEDI0382 is reported., Cohort 2: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 1, 7, and 14|Cohort 1: Terminal Half Life (t1/2) of MEDI0382, The t1/2 is the time measured for the concentration to decrease by one half after the dose of MEDI0382., Cohort 1: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 22 and 49|Cohort 2: Terminal Half Life (t1/2) of MEDI0382, The t1/2 is the time measured for the concentration to decrease by one half after the dose of MEDI0382., Cohort 2: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 1, 7, and 14|Cohort 1: Accumulation Ratio (Racc) of MEDI0382, The Racc was calculated using the AUC method which account for the overall exposure measured using the specified time points on Day 22 and Day 49. Racc was calculated using the formula, Racc of Day 49 = AUCt of Day 49/AUCt of Day 22., Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 22 and 49|Cohort 2: Accumulation Ratio of MEDI0382, The Racc was calculated using the AUC method which account for the overall exposure measured using the specified time points on Day 1, Day 7 and Day 14. Racc was calculated using the formulas: Racc of Day 7 = AUCt of Day 7/AUCt of Day 1; Racc of Day 14 = AUCt of Day 14/AUCt of Day 1., Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 1, 7, and 14|Cohort 1: Trough Plasma Concentration (Ctrough) of MEDI0382, Trough plasma concentration is the measured concentration from the plasma concentration-time data at the end of a dosing interval at steady state., Cohort 1: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 22 and 49|Cohort 2: Trough Plasma Concentration (Ctrough) of MEDI0382, Trough plasma concentration is the measured concentration from the plasma concentration time data at the end of a dosing interval at steady state., Cohort 2: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 1, 7, and 14|Cohort 1 and Cohort 2: Number of Participants With Positive Anti-drug Antibodies (ADA) to MEDI0382, Participants with positive serum antibodies to MEDI0382 are reported., Baseline (Day 1), Day 29, Day 50, and Follow-up Visit 2 (28 days after the last dose [approximately 64 days])
Sponsor/Collaborators: Sponsor: MedImmune LLC
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 65
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2017-09-04
Completion Date: 2018-01-23
Results First Posted: 2019-11-19
Last Update Posted: 2019-11-19
Locations: Research Site, Berlin, 10117, Germany|Research Site, Magdeburg, 39120, Germany|Research Site, Mainz, 55116, Germany|Research Site, Neu-Ulm, 89231, Germany|Research Site, Neuss, 41460, Germany
URL: https://clinicaltrials.gov/show/NCT03244800