{"protocolSection":{"identificationModule":{"nctId":"NCT03645421","orgStudyIdInfo":{"id":"D5674C00001"},"organization":{"fullName":"AstraZeneca","class":"INDUSTRY"},"briefTitle":"Safety and Tolerability Study of MEDI0382 in Japanese Preobese or Obese Subjects With Type 2 Diabetes","officialTitle":"A Phase IIa, Randomised, Parallel, Double-Blind,Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of MEDI0382 in Japanese Preobese or Obese Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise"},"statusModule":{"statusVerifiedDate":"2019-12","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2018-08-10","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2019-01-17","type":"ACTUAL"},"completionDateStruct":{"date":"2019-01-17","type":"ACTUAL"},"studyFirstSubmitDate":"2018-06-25","studyFirstSubmitQcDate":"2018-08-23","studyFirstPostDateStruct":{"date":"2018-08-24","type":"ACTUAL"},"resultsFirstSubmitDate":"2019-12-05","resultsFirstSubmitQcDate":"2019-12-05","resultsFirstPostDateStruct":{"date":"2019-12-23","type":"ACTUAL"},"lastUpdateSubmitDate":"2019-12-05","lastUpdatePostDateStruct":{"date":"2019-12-23","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"AstraZeneca","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":false,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"This is a Phase 2a study designed to assess the safety and tolerability of MEDI0382 titrated up to a dose level of 100, 200 or 300 µg from 50 µg vs Placebo across 48 days in Japanese subjects.\n\nThe study D5674C00001 can be conducted with a reasonable expectation of safety and tolerability in Japanese T2DM patients. The design of this study has taken into account the known benefits and risks of GLP-1 receptor agonists and glucagon receptor agonists as well as the translatable effects observed in nonclinical studies of MEDI0382.","detailedDescription":"This is a randomized, parallel-group, placebo-controlled, double-blind, multicenter Phase Ⅱa study to evaluate the safety, efficacy, and pharmacokinetics of MEDI0382 in Japanese preobese and obese subjects with type 2 diabetes who have inadequate glycemic control with diet and exercise. Subject fulfilling all of the inclusion criteria and none of the exclusion criteria will be randomised in a 1:1:1:1 ratio to four treatment arms. This is a Phase IIa study designed to evaluate the dose range for MEDI0382 to explore the safety profile, as well as blood glucose control and weight loss effects of MEDI0382 in Japanese patients with T2DM. The design of this study has taken into account the known benefits and risks of GLP-1 receptor agonists and glucagon receptor agonists as well as the translatable effects observed in nonclinical studies of MEDI0382, such that benefit-risk balance for the Japanese preobese and obese patients with T2DM in this study is considered favourable. A treatment period of 48 days is required to properly evaluate the dose range and safety and tolerability in three different doses. Inclusion of placebo in the study allows appropriate basis of AEs, glycaemic control, and weight loss. Benefits related to participation in this trial include close follow-up of a subject's diabetes and treatment with anti-diabetes agents. Although one of possible treatments is placebo, appropriate rescue therapy for worsening glycaemic control will be implemented if required."},"conditionsModule":{"conditions":["Type 2 Diabetes"],"keywords":["Diabetes","MEDI0382","D5674C00001","T2DM","Type 2 Diabetes"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":61,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"placebo","type":"PLACEBO_COMPARATOR","description":"Placebo per day,SC injection on 48 days.","interventionNames":["Drug: PlaceboA","Drug: PlaceboB"]},{"label":"MEDI0382 100μg","type":"EXPERIMENTAL","description":"50 μg/day,SC injection on the first 5 days and 100 μg/day,SC injection on 43 days","interventionNames":["Drug: MEDI0382 100 μg","Drug: MEDI0382 50 ug"]},{"label":"MEDI0382 200μg","type":"EXPERIMENTAL","description":"50 μg/day,SC injection on the first 5 days, 100 μg/day,SC injection on 7 days and 200 μg/day,SC injection on 36 days.","interventionNames":["Drug: MEDI0382 100 μg","Drug: MEDI0382 200 μg","Drug: MEDI0382 50 ug"]},{"label":"MEDI0382 300μg","type":"EXPERIMENTAL","description":"50 μg/day,SC injection on the first 5 days, 100 μg/day,SC injection on 7 days, 200 μg/day,SC injection on 7 days and 300 μg/day,SC injection on 29 days","interventionNames":["Drug: MEDI0382 100 μg","Drug: MEDI0382 200 μg","Drug: MEDI0382 300 μg","Drug: MEDI0382 50 ug"]}],"interventions":[{"type":"DRUG","name":"MEDI0382 100 μg","description":"Solution for injection in 1.0 mL pre-filled syringe, 100 μg per dose, 1 dose","armGroupLabels":["MEDI0382 100μg","MEDI0382 200μg","MEDI0382 300μg"]},{"type":"DRUG","name":"MEDI0382 200 μg","description":"Solution for injection in 1.0 mL pre filled syringe 200 μg per dose, 1 dose","armGroupLabels":["MEDI0382 200μg","MEDI0382 300μg"]},{"type":"DRUG","name":"MEDI0382 300 μg","description":"Solution for injection in 1.0 mL pre filled syringe, 300 μg per dose, 1 dose","armGroupLabels":["MEDI0382 300μg"]},{"type":"DRUG","name":"PlaceboA","description":"1.0 mL liquid formulation per Vial","armGroupLabels":["placebo"]},{"type":"DRUG","name":"MEDI0382 50 ug","description":"Solution for injection, 1.0 mL per vial, 50 ug","armGroupLabels":["MEDI0382 100μg","MEDI0382 200μg","MEDI0382 300μg"]},{"type":"DRUG","name":"PlaceboB","description":"Solution for injection in 1.0 mL pre-filled syringe.","armGroupLabels":["placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Mean Change From Baseline in 24-Hour Heart Rate at Days 20 and 48","description":"Twenty four-hour heart rate was determined using an ambulatory blood pressure monitoring (ABPM) device, and the mean change from baseline in the 24-hour heart rate is presented for Days 20 and 48.","timeFrame":"Baseline (Day -1) and Days 20 and 48."},{"measure":"Mean Change From Baseline in 24-Hour Systolic and Diastolic Blood Pressure (BP) at Days 20 and 48","description":"Twenty four-hour BP was determined using an ABPM device, and the mean change from baseline in the 24-hour systolic BP and 24-hour diastolic BP are presented for Days 20 and 48.","timeFrame":"Baseline (Day -1) and Days 20 and 48."},{"measure":"Mean Percentage Change From Baseline in Glucose Area Under the Plasma Concentration Curve (AUC[0-4h]) as Measured by a Standardised Mixed-Meal Test (MMT) at Day 48","description":"The MMT was conducted following a minimum 8-hour fast. Blood samples for glucose monitoring were taken 15 minutes before the patient consumed a standardised meal, and samples were taken at intervals after the meal, up to 4 hours. The MMT glucose AUC(0-4h) was calculated using a trapezoidal method, and the mean percentage change from baseline at Day 48 was analysed using an analysis of covariance (ANCOVA) model with treatment group as a factor and baseline as a covariate.","timeFrame":"Baseline (Day -1) and Day 48: 15 minutes before standardised meal, and then at 15, 30, 45, 60, 90, 120, 180 and 240 minutes (+/-5 minutes) after consumption of the standardised meal."},{"measure":"Mean Percentage Change From Baseline in Body Weight at Day 48","description":"The mean percentage change from baseline in body weight at Day 48 was analysed using an ANCOVA model with treatment group as a factor and baseline as a covariate. For patients who prematurely discontinued IP, the last on-treatment measurement, regardless of rescue medication, was used (last observation carried forward \\[LOCF\\]).","timeFrame":"Baseline (Day -1) and Day 48."},{"measure":"Mean Change From Baseline in Heart Rate Measured by Electrocardiogram (ECG) at Day 48.","description":"Digital ECGs were taken at baseline and predose and postdose on Days 1, 6, 13, 20 and 48. The mean change from baseline is presented.","timeFrame":"Baseline (Day -1) and Days 1, 6, 13, 20 and 48: predose and 6 hours (+/-15 minutes) postdose."},{"measure":"Number of Patients Who Experienced Adverse Events (AEs)","description":"AEs were collected from Day 1 of treatment up to 14 days after the last dose of IP. Serious AEs (SAEs) were collected from signing of informed consent. The numbers of patients who experienced any AE, any SAE (including events with an outcome of death), and any AE leading to discontinuation of IP are presented.","timeFrame":"Day 1 up to 14 days after the last dose of IP (approximately 9 weeks)."}],"secondaryOutcomes":[{"measure":"Mean Change From Baseline in HbA1c at Day 48","description":"The mean change from baseline in HbA1c at Day 48 was analysed using an ANCOVA model with treatment group as a factor and baseline as a covariate. For patients who prematurely discontinued IP, or for patients who did not have a measurement taken on Day 48, the last post-baseline measurement, regardless of rescue medication, was used (LOCF).","timeFrame":"Baseline (Day -1) and Day 48 (predose)."},{"measure":"Mean Change From Baseline in Fasting Plasma Glucose at Day 48","description":"The mean change from baseline in fasting plasma glucose at Day 48 was analysed using an ANCOVA model with treatment group as a factor and baseline as a covariate. For patients who prematurely discontinued IP, or for patients who did not have a measurement taken on Day 48, the last post-baseline measurement, regardless of rescue medication, was used (LOCF).","timeFrame":"Baseline (Day -1) and Day 48 (predose)."},{"measure":"Mean Change From Baseline in Fructosamine at Day 48","description":"The mean change from baseline in fructosamine at Day 48 was analysed using an ANCOVA model with treatment group as a factor and baseline as a covariate. For patients who prematurely discontinued IP, the last on-treatment measurement, regardless of rescue medication, was used (LOCF).","timeFrame":"Baseline (Day -1) and Day 48 (predose)."},{"measure":"Mean Change From Baseline in the Percentage of Time in Hyperglycaemia Over 24 Hours at Days 5, 12, 19 and 47","description":"Hyperglycaemia was defined as blood glucose \\>7.8 mmol/L or \\>140 mg/dL. Continuous glucose monitoring used a device fitted to the upper arm by trained study site staff to measure and record interstitial glucose levels every 15 minutes. Analysis was based on 24-hour readings defined as the first available time point with a valid continuous glucose monitoring glucose reading. The change in the percentage time in hyperglycaemia from the last day of baseline continuous glucose monitoring over 24 hours to the end of dosing at each dose level for the indicated timepoints is presented.","timeFrame":"Baseline (Day -8 to -2) and Days 5, 12, 19 and 47."},{"measure":"Mean Change From Baseline in the Percentage of Time in Hypoglycaemia Over 24 Hours at Days 5, 12, 19 and 47","description":"Hypoglycaemia was defined as blood glucose \\<3 mmol/L or \\<54 mg/dL. Continuous glucose monitoring used a device fitted to the upper arm by trained study site staff to measure and record interstitial glucose levels every 15 minutes. Analysis was based on 24-hour readings defined as the first available time point with a valid continuous glucose monitoring glucose reading. The change in the percentage time in hypoglycaemia from the last day of baseline continuous glucose monitoring over 24 hours to the end of dosing at each dose level for the timepoints is presented.","timeFrame":"Baseline (Day -8 to -2) and Days 5, 12, 19 and 47."},{"measure":"Mean Change From Baseline in the Percentage of Time in Hyperglycaemia Over 5 Days for 50 mcg Dose Level and 7 Days for Other Dose Levels","description":"Hyperglycaemia was defined as blood glucose \\>7.8 mmol/L or \\>140 mg/dL. Continuous glucose monitoring used a device fitted to the upper arm by trained study site staff to measure and record interstitial glucose levels every 15 minutes. Analysis was based on 24-hour readings defined as the first available time point with a valid continuous glucose monitoring glucose reading. The change in the percentage time in hyperglycaemia from the last day of baseline continuous glucose monitoring over 5 days for 50 mcg MEDI0382 and 7 days for each of the dose levels (during titration) is presented, up to Day 47, per randomised group.","timeFrame":"Baseline (Day -8 to -2) and Days 1 to 5, 6 to 12, 13 to 19 and 41 to 47."},{"measure":"Mean Change From Baseline in the Percentage of Time in Hypoglycaemia Over 5 Days for 50 mcg Dose Level and 7 Days for Other Dose Levels","description":"Hyp0glycaemia was defined as blood glucose \\<3 mmol/L or \\<54 mg/dL. Continuous glucose monitoring used a device fitted to the upper arm by trained study site staff to measure and record interstitial glucose levels every 15 minutes. Analysis was based on 24-hour readings defined as the first available time point with a valid continuous glucose monitoring glucose reading. The change in the percentage time in hypoglycaemia from the last day of baseline continuous glucose monitoring over 5 days for 50 mcg MEDI0382 and 7 days for each of the randomised dose levels (during titration) is presented, up to Day 47, per randomised group.","timeFrame":"Baseline (Day -8 to -2) and Days 1 to 5, 6 to 12, 13 to 19 and 41 to 47."},{"measure":"Mean Trough Plasma Concentration (Ctrough) of MEDI0382 up to Day 48","description":"To evaluate pharmacokinetics (PK), blood samples were collected predose and Ctrough of MEDI0382 was determined. Results are presented for Days 2, 5, 34 and 48.","timeFrame":"Blood samples collected predose on Days 1 to 6, 13, 20, 34 and 48."},{"measure":"Number of Patients With Antidrug Antibody (ADA) Response to MEDI0382","description":"The number of patients who were ADA positive at baseline and/or post-baseline are presented. Persistent positive was defined as positive at ≥2 post-baseline assessments (with ≥16 weeks between first and last positive) or positive at the last post-baseline assessment. Transiently positive was defined as having at least 1 post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive.\n\n+ve = positive","timeFrame":"Samples were collected predose on days 1, 13, 20 and 48, and 7 to 14 days after administration of last dose of IP."}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Individuals whose HbA1c range of 7.0% to 10.5% (inclusive) at screening.\n* Individuals who are diagnosed with T2DM\n* Individuals whose current condition at enrolment (Visit 1) is drug naïve\n* BMI within the range of 24 - 40 kg/m2 (inclusive) at screening\n\nExclusion Criteria:\n\n* Subjects with any of the following results at screening:\n* Aspartate transaminase (AST) ≥ 2.5 × upper limit of normal (ULN)\n* Alanine transaminase (ALT) ≥ 2.5 × ULN\n* Total bilirubin (TBL) ≥ 2 × ULN\n* Impaired renal function defined as estimated glomerular filtration rate (eGFR) ≤ 60 mL/minute/1.73 m2 at screening\n* Participation in another clinical study with an investigational product administered in the last 30 days or 5 half-lives of the drug (whichever is longer) at the time of screening","healthyVolunteers":false,"sex":"ALL","minimumAge":"20 Years","maximumAge":"120 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"locations":[{"facility":"Research Site","city":"Chūōku","zip":"103-0027","country":"Japan","geoPoint":{"lat":33.63867,"lon":130.67068}},{"facility":"Research Site","city":"Chūōku","zip":"104-0031","country":"Japan","geoPoint":{"lat":33.63867,"lon":130.67068}},{"facility":"Research Site","city":"Shinjuku-ku","zip":"160-0008","country":"Japan"},{"facility":"Research Site","city":"Shinjuku-ku","zip":"162-0053","country":"Japan"},{"facility":"Research Site","city":"Suita-shi","zip":"565-0853","country":"Japan"}]},"referencesModule":{"seeAlsoLinks":[{"label":"d5674c00001 CSP redacted","url":"https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=D5674C00001&amp;attachmentIdentifier=178319f5-5ef4-4cca-856f-fdfb344927ae&amp;fileName=d5674c00001_CSP_redacted.pdf&amp;versionIdentifier="},{"label":"Statistical Analysis Plan (SAP) redacted","url":"https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=D5674C00001&amp;attachmentIdentifier=725e1184-cf38-400c-bd99-3105851a5afa&amp;fileName=d5674c00001_SAP_redacted.pdf&amp;versionIdentifier="}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Patients with an early stage of T2DM who had inadequate blood glucose control, defined as glycated haemoglobin (HbA1c) between 7.0% and 10.5%, and who were treated with diet and exercise were enrolled. A body mass index of 24 to 40 kg/m2 was also a requirement. Patients with acutely decompensated blood glucose control were excluded.","recruitmentDetails":"Preobese/obese Japanese adults with Type 2 diabetes mellitus (T2DM) were recruited to this Phase IIa randomised, parallel-group, placebo-controlled, double-blind, study at 5 centres in Japan. The first patient started in August 2018 and the last patient completed in January 2019.","groups":[{"id":"FG000","title":"Placebo","description":"Patients were randomised to receive MEDI0382 matched placebo for 48 days."},{"id":"FG001","title":"MEDI0382 100 mcg","description":"Patients were randomised to receive 100 micrograms (mcg) MEDI0382 per day by subcutaneous (SC) injection, titrated as follows: 50 mcg/day for 5 days and then 100 mcg/day for 43 days."},{"id":"FG002","title":"MEDI0382 200 mcg","description":"Patients were randomised to receive 200 mcg MEDI0382 per day by SC injection, titrated as follows: 50 mcg/day for 5 days, 100 mcg/day for 7 days and then 200 mcg/day for 36 days."},{"id":"FG003","title":"MEDI0382 300 mcg","description":"Patients were randomised to receive 300 mcg MEDI0382 per day by SC injection, titrated as follows: 50 mcg/day for 5 days, 100 mcg/day for 7 days, 200 mcg/day for 7 days and then 300 mcg/day for 29 days."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"16"},{"groupId":"FG001","numSubjects":"15"},{"groupId":"FG002","numSubjects":"15"},{"groupId":"FG003","numSubjects":"15"}]},{"type":"Received Investigational Product (IP)","achievements":[{"groupId":"FG000","numSubjects":"16"},{"groupId":"FG001","numSubjects":"15"},{"groupId":"FG002","numSubjects":"15"},{"groupId":"FG003","numSubjects":"15"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"16"},{"groupId":"FG001","numSubjects":"15"},{"groupId":"FG002","numSubjects":"10"},{"groupId":"FG003","numSubjects":"11"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"5"},{"groupId":"FG003","numSubjects":"4"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"4"},{"groupId":"FG003","numSubjects":"1"}]},{"type":"Withdrawal by patient","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"3"}]},{"type":"Study specific withdrawal criteria","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"Baseline characteristics are presented for the Full Analysis Set which included all randomised patients who received at least 1 dose of IP, analysed according to their randomised treatment group.","groups":[{"id":"BG000","title":"Placebo","description":"Patients were randomised to receive MEDI0382 matched placebo for 48 days."},{"id":"BG001","title":"MEDI0382 100 mcg","description":"Patients were randomised to receive 100 mcg MEDI0382 per day by SC injection, titrated as follows: 50 mcg/day for 5 days and then 100 mcg/day for 43 days."},{"id":"BG002","title":"MEDI0382 200 mcg","description":"Patients were randomised to receive 200 mcg MEDI0382 per day by SC injection, titrated as follows: 50 mcg/day for 5 days, 100 mcg/day for 7 days and then 200 mcg/day for 36 days."},{"id":"BG003","title":"MEDI0382 300 mcg","description":"Patients were randomised to receive 300 mcg MEDI0382 per day by SC injection, titrated as follows: 50 mcg/day for 5 days, 100 mcg/day for 7 days, 200 mcg/day for 7 days and then 300 mcg/day for 29 days."},{"id":"BG004","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"16"},{"groupId":"BG001","value":"15"},{"groupId":"BG002","value":"15"},{"groupId":"BG003","value":"15"},{"groupId":"BG004","value":"61"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"60.0","spread":"8.6"},{"groupId":"BG001","value":"56.7","spread":"10.7"},{"groupId":"BG002","value":"58.7","spread":"11.3"},{"groupId":"BG003","value":"57.5","spread":"9.2"},{"groupId":"BG004","value":"58.2","spread":"9.8"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"7"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"2"},{"groupId":"BG004","value":"14"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"13"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"13"},{"groupId":"BG003","value":"13"},{"groupId":"BG004","value":"47"}]}]}]},{"title":"Race/Ethnicity, Customized","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"Asian","categories":[{"measurements":[{"groupId":"BG000","value":"16"},{"groupId":"BG001","value":"15"},{"groupId":"BG002","value":"15"},{"groupId":"BG003","value":"15"},{"groupId":"BG004","value":"61"}]}]},{"title":"Not Hispanic or Latino","categories":[{"measurements":[{"groupId":"BG000","value":"16"},{"groupId":"BG001","value":"15"},{"groupId":"BG002","value":"15"},{"groupId":"BG003","value":"15"},{"groupId":"BG004","value":"61"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Mean Change From Baseline in 24-Hour Heart Rate at Days 20 and 48","description":"Twenty four-hour heart rate was determined using an ambulatory blood pressure monitoring (ABPM) device, and the mean change from baseline in the 24-hour heart rate is presented for Days 20 and 48.","populationDescription":"The Safety Analysis Set included all randomised patients who received at least 1 dose of IP, analysed according to the treatment received. Patients with data available at each timepoint are presented.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"beats/minute","timeFrame":"Baseline (Day -1) and Days 20 and 48.","groups":[{"id":"OG000","title":"Placebo","description":"Patients were randomised to receive MEDI0382 matched placebo for 48 days."},{"id":"OG001","title":"MEDI0382 100 mcg","description":"Patients were randomised to receive 100 mcg MEDI0382 per day by SC injection, titrated as follows: 50 mcg/day for 5 days and then 100 mcg/day for 43 days."},{"id":"OG002","title":"MEDI0382 200 mcg","description":"Patients were randomised to receive 200 mcg MEDI0382 per day by SC injection, titrated as follows: 50 mcg/day for 5 days, 100 mcg/day for 7 days and then 200 mcg/day for 36 days."},{"id":"OG003","title":"MEDI0382 300 mcg","description":"Patients were randomised to receive 300 mcg MEDI0382 per day by SC injection, titrated as follows: 50 mcg/day for 5 days, 100 mcg/day for 7 days, 200 mcg/day for 7 days and then 300 mcg/day for 29 days."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"15"},{"groupId":"OG002","value":"15"},{"groupId":"OG003","value":"15"}]}],"classes":[{"title":"Day 20","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"15"},{"groupId":"OG002","value":"12"},{"groupId":"OG003","value":"12"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-1.86","spread":"7.43"},{"groupId":"OG001","value":"6.65","spread":"7.46"},{"groupId":"OG002","value":"13.50","spread":"5.86"},{"groupId":"OG003","value":"15.80","spread":"7.86"}]}]},{"title":"Day 48","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"15"},{"groupId":"OG002","value":"8"},{"groupId":"OG003","value":"9"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.25","spread":"7.24"},{"groupId":"OG001","value":"7.87","spread":"8.60"},{"groupId":"OG002","value":"12.81","spread":"4.93"},{"groupId":"OG003","value":"15.22","spread":"5.50"}]}]}]},{"type":"PRIMARY","title":"Mean Change From Baseline in 24-Hour Systolic and Diastolic Blood Pressure (BP) at Days 20 and 48","description":"Twenty four-hour BP was determined using an ABPM device, and the mean change from baseline in the 24-hour systolic BP and 24-hour diastolic BP are presented for Days 20 and 48.","populationDescription":"The Safety Analysis Set included all randomised patients who received at least 1 dose of IP, analysed according to the treatment received. Patients with data available at each timepoint are presented.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"millimetres of mercury","timeFrame":"Baseline (Day -1) and Days 20 and 48.","groups":[{"id":"OG000","title":"Placebo","description":"Patients were randomised to receive MEDI0382 matched placebo for 48 days."},{"id":"OG001","title":"MEDI0382 100 mcg","description":"Patients were randomised to receive 100 mcg MEDI0382 per day by SC injection, titrated as follows: 50 mcg/day for 5 days and then 100 mcg/day for 43 days."},{"id":"OG002","title":"MEDI0382 200 mcg","description":"Patients were randomised to receive 200 mcg MEDI0382 per day by SC injection, titrated as follows: 50 mcg/day for 5 days, 100 mcg/day for 7 days and then 200 mcg/day for 36 days."},{"id":"OG003","title":"MEDI0382 300 mcg","description":"Patients were randomised to receive 300 mcg MEDI0382 per day by SC injection, titrated as follows: 50 mcg/day for 5 days, 100 mcg/day for 7 days, 200 mcg/day for 7 days and then 300 mcg/day for 29 days."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"15"},{"groupId":"OG002","value":"15"},{"groupId":"OG003","value":"15"}]}],"classes":[{"title":"24-hour Systolic BP: Day 20","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"15"},{"groupId":"OG002","value":"12"},{"groupId":"OG003","value":"12"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"2.98","spread":"9.00"},{"groupId":"OG001","value":"-4.09","spread":"8.93"},{"groupId":"OG002","value":"-7.24","spread":"10.54"},{"groupId":"OG003","value":"-2.48","spread":"9.28"}]}]},{"title":"24-hour Systolic BP: Day 48","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"15"},{"groupId":"OG002","value":"8"},{"groupId":"OG003","value":"9"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.08","spread":"14.32"},{"groupId":"OG001","value":"-2.27","spread":"12.42"},{"groupId":"OG002","value":"-5.17","spread":"19.35"},{"groupId":"OG003","value":"-6.97","spread":"7.48"}]}]},{"title":"24-hour Diastolic BP: Day 20","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"15"},{"groupId":"OG002","value":"12"},{"groupId":"OG003","value":"12"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.98","spread":"4.34"},{"groupId":"OG001","value":"-0.62","spread":"3.42"},{"groupId":"OG002","value":"-1.41","spread":"4.56"},{"groupId":"OG003","value":"0.81","spread":"5.58"}]}]},{"title":"24-hour Diastolic BP: Day 48","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"15"},{"groupId":"OG002","value":"8"},{"groupId":"OG003","value":"9"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.06","spread":"6.82"},{"groupId":"OG001","value":"-0.66","spread":"4.56"},{"groupId":"OG002","value":"-0.27","spread":"9.17"},{"groupId":"OG003","value":"-0.68","spread":"3.88"}]}]}]},{"type":"PRIMARY","title":"Mean Percentage Change From Baseline in Glucose Area Under the Plasma Concentration Curve (AUC[0-4h]) as Measured by a Standardised Mixed-Meal Test (MMT) at Day 48","description":"The MMT was conducted following a minimum 8-hour fast. Blood samples for glucose monitoring were taken 15 minutes before the patient consumed a standardised meal, and samples were taken at intervals after the meal, up to 4 hours. The MMT glucose AUC(0-4h) was calculated using a trapezoidal method, and the mean percentage change from baseline at Day 48 was analysed using an analysis of covariance (ANCOVA) model with treatment group as a factor and baseline as a covariate.","populationDescription":"The Full Analysis Set included all randomised patients who received at least 1 dose of IP, analysed according to their randomised treatment group. MMTs were not conducted on patients who prematurely discontinued IP.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"Percentage change","timeFrame":"Baseline (Day -1) and Day 48: 15 minutes before standardised meal, and then at 15, 30, 45, 60, 90, 120, 180 and 240 minutes (+/-5 minutes) after consumption of the standardised meal.","groups":[{"id":"OG000","title":"Placebo","description":"Patients were randomised to receive MEDI0382 matched placebo for 48 days."},{"id":"OG001","title":"MEDI0382 100 mcg","description":"Patients were randomised to receive 100 mcg MEDI0382 per day by SC injection, titrated as follows: 50 mcg/day for 5 days and then 100 mcg/day for 43 days."},{"id":"OG002","title":"MEDI0382 200 mcg","description":"Patients were randomised to receive 200 mcg MEDI0382 per day by SC injection, titrated as follows: 50 mcg/day for 5 days, 100 mcg/day for 7 days and then 200 mcg/day for 36 days."},{"id":"OG003","title":"MEDI0382 300 mcg","description":"Patients were randomised to receive 300 mcg MEDI0382 per day by SC injection, titrated as follows: 50 mcg/day for 5 days, 100 mcg/day for 7 days, 200 mcg/day for 7 days and then 300 mcg/day for 29 days."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"15"},{"groupId":"OG002","value":"15"},{"groupId":"OG003","value":"15"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2.45","lowerLimit":"-3.37","upperLimit":"8.26"},{"groupId":"OG001","value":"-39.66","lowerLimit":"-45.67","upperLimit":"-33.66"},{"groupId":"OG002","value":"-31.16","lowerLimit":"-38.61","upperLimit":"-23.71"},{"groupId":"OG003","value":"-37.86","lowerLimit":"-44.95","upperLimit":"-30.76"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Pair-wise comparison of MEDI0382 100 mcg versus Placebo.","nonInferiorityType":"OTHER","pValue":"<0.0001","statisticalMethod":"ANCOVA","statisticalComment":"Analysis used treatment group as a factor and baseline as a covariate.","paramType":"Least squares (LS) mean difference","paramValue":"-42.11","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-50.47","ciUpperLimit":"-33.75","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"4.16","estimateComment":"Treatment difference = MEDI0382 100 mcg - Placebo"},{"groupIds":["OG000","OG002"],"groupDescription":"Pair-wise comparison of MEDI0382 200 mcg versus Placebo.","nonInferiorityType":"OTHER","pValue":"<0.0001","statisticalMethod":"ANCOVA","statisticalComment":"Analysis used treatment group as a factor and baseline as a covariate.","paramType":"LS mean difference","paramValue":"-33.61","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-43.04","ciUpperLimit":"-24.18","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"4.69","estimateComment":"Treatment difference = MEDI0382 200 mcg - Placebo"},{"groupIds":["OG000","OG003"],"groupDescription":"Pair-wise comparison of MEDI0382 300 mcg versus Placebo.","nonInferiorityType":"OTHER","pValue":"<0.0001","statisticalMethod":"ANCOVA","statisticalComment":"Analysis used treatment group as a factor and baseline as a covariate.","paramType":"LS mean difference","paramValue":"-40.30","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-49.49","ciUpperLimit":"-31.12","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"4.57","estimateComment":"Treatment difference = MEDI0382 300 mcg - Placebo"}]},{"type":"PRIMARY","title":"Mean Percentage Change From Baseline in Body Weight at Day 48","description":"The mean percentage change from baseline in body weight at Day 48 was analysed using an ANCOVA model with treatment group as a factor and baseline as a covariate. For patients who prematurely discontinued IP, the last on-treatment measurement, regardless of rescue medication, was used (last observation carried forward \\[LOCF\\]).","populationDescription":"The Full Analysis Set included all randomised patients who received at least 1 dose of IP, analysed according to their randomised treatment group. Patients with data available are presented.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"Percentage change","timeFrame":"Baseline (Day -1) and Day 48.","groups":[{"id":"OG000","title":"Placebo","description":"Patients were randomised to receive MEDI0382 matched placebo for 48 days."},{"id":"OG001","title":"MEDI0382 100 mcg","description":"Patients were randomised to receive 100 mcg MEDI0382 per day by SC injection, titrated as follows: 50 mcg/day for 5 days and then 100 mcg/day for 43 days."},{"id":"OG002","title":"MEDI0382 200 mcg","description":"Patients were randomised to receive 200 mcg MEDI0382 per day by SC injection, titrated as follows: 50 mcg/day for 5 days, 100 mcg/day for 7 days and then 200 mcg/day for 36 days."},{"id":"OG003","title":"MEDI0382 300 mcg","description":"Patients were randomised to receive 300 mcg MEDI0382 per day by SC injection, titrated as follows: 50 mcg/day for 5 days, 100 mcg/day for 7 days, 200 mcg/day for 7 days and then 300 mcg/day for 29 days."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"15"},{"groupId":"OG002","value":"15"},{"groupId":"OG003","value":"15"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.82","lowerLimit":"-2.06","upperLimit":"0.43"},{"groupId":"OG001","value":"-2.12","lowerLimit":"-3.40","upperLimit":"-0.84"},{"groupId":"OG002","value":"-3.34","lowerLimit":"-4.68","upperLimit":"-2.01"},{"groupId":"OG003","value":"-3.34","lowerLimit":"-4.61","upperLimit":"-2.06"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Pair-wise comparison of MEDI0382 100 mcg versus Placebo.","nonInferiorityType":"OTHER","pValue":"0.1476","statisticalMethod":"ANCOVA","statisticalComment":"Analysis used treatment group as a factor and baseline as a covariate.","paramType":"LS mean difference","paramValue":"-1.30","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-3.08","ciUpperLimit":"0.47","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.89","estimateComment":"Treatment difference = MEDI0382 100 mcg - Placebo"},{"groupIds":["OG000","OG002"],"groupDescription":"Pair-wise comparison of MEDI0382 200 mcg versus Placebo.","nonInferiorityType":"OTHER","pValue":"0.0080","statisticalMethod":"ANCOVA","statisticalComment":"Analysis used treatment group as a factor and baseline as a covariate.","paramType":"LS mean difference","paramValue":"-2.53","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-4.37","ciUpperLimit":"-0.69","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.92","estimateComment":"Treatment difference = MEDI0382 200 mcg - Placebo"},{"groupIds":["OG000","OG003"],"groupDescription":"Pair-wise comparison of MEDI0382 300 mcg versus Placebo.","nonInferiorityType":"OTHER","pValue":"0.0063","statisticalMethod":"ANCOVA","statisticalComment":"Analysis used treatment group as a factor and baseline as a covariate.","paramType":"LS mean difference","paramValue":"-2.52","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-4.30","ciUpperLimit":"-0.74","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.89","estimateComment":"Treatment difference = MEDI0382 300 mcg - Placebo"}]},{"type":"PRIMARY","title":"Mean Change From Baseline in Heart Rate Measured by Electrocardiogram (ECG) at Day 48.","description":"Digital ECGs were taken at baseline and predose and postdose on Days 1, 6, 13, 20 and 48. The mean change from baseline is presented.","populationDescription":"The Safety Analysis Set included all randomised patients who received at least 1 dose of IP, analysed according to the treatment received. Patients with data available at each timepoint are presented.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"beats/minute","timeFrame":"Baseline (Day -1) and Days 1, 6, 13, 20 and 48: predose and 6 hours (+/-15 minutes) postdose.","groups":[{"id":"OG000","title":"Placebo","description":"Patients were randomised to receive MEDI0382 matched placebo for 48 days."},{"id":"OG001","title":"MEDI0382 100 mcg","description":"Patients were randomised to receive 100 mcg MEDI0382 per day by SC injection, titrated as follows: 50 mcg/day for 5 days and then 100 mcg/day for 43 days."},{"id":"OG002","title":"MEDI0382 200 mcg","description":"Patients were randomised to receive 200 mcg MEDI0382 per day by SC injection, titrated as follows: 50 mcg/day for 5 days, 100 mcg/day for 7 days and then 200 mcg/day for 36 days."},{"id":"OG003","title":"MEDI0382 300 mcg","description":"Patients were randomised to receive 300 mcg MEDI0382 per day by SC injection, titrated as follows: 50 mcg/day for 5 days, 100 mcg/day for 7 days, 200 mcg/day for 7 days and then 300 mcg/day for 29 days."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"15"},{"groupId":"OG002","value":"15"},{"groupId":"OG003","value":"15"}]}],"classes":[{"title":"Day 1: 6 hours postdose","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"15"},{"groupId":"OG002","value":"15"},{"groupId":"OG003","value":"15"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.77","spread":"7.20"},{"groupId":"OG001","value":"4.24","spread":"5.00"},{"groupId":"OG002","value":"2.18","spread":"8.62"},{"groupId":"OG003","value":"6.27","spread":"7.91"}]}]},{"title":"Day 6: predose","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"15"},{"groupId":"OG002","value":"14"},{"groupId":"OG003","value":"14"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-2.85","spread":"4.93"},{"groupId":"OG001","value":"1.84","spread":"8.56"},{"groupId":"OG002","value":"7.69","spread":"7.11"},{"groupId":"OG003","value":"10.79","spread":"5.87"}]}]},{"title":"Day 6: 6 hours postdose","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"15"},{"groupId":"OG002","value":"14"},{"groupId":"OG003","value":"14"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.02","spread":"8.79"},{"groupId":"OG001","value":"4.62","spread":"9.11"},{"groupId":"OG002","value":"8.88","spread":"6.06"},{"groupId":"OG003","value":"10.67","spread":"7.59"}]}]},{"title":"Day 13: predose","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"15"},{"groupId":"OG002","value":"14"},{"groupId":"OG003","value":"13"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-2.63","spread":"5.58"},{"groupId":"OG001","value":"6.91","spread":"8.83"},{"groupId":"OG002","value":"8.93","spread":"6.84"},{"groupId":"OG003","value":"11.74","spread":"7.92"}]}]},{"title":"Day 13: 6 hours postdose","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"15"},{"groupId":"OG002","value":"14"},{"groupId":"OG003","value":"13"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"2.19","spread":"9.13"},{"groupId":"OG001","value":"6.40","spread":"11.41"},{"groupId":"OG002","value":"16.62","spread":"7.14"},{"groupId":"OG003","value":"13.31","spread":"9.45"}]}]},{"title":"Day 20: predose","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"15"},{"groupId":"OG002","value":"13"},{"groupId":"OG003","value":"12"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-1.85","spread":"7.52"},{"groupId":"OG001","value":"6.24","spread":"8.02"},{"groupId":"OG002","value":"11.97","spread":"8.12"},{"groupId":"OG003","value":"13.03","spread":"8.65"}]}]},{"title":"Day 20: 6 hours postdose","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"15"},{"groupId":"OG002","value":"13"},{"groupId":"OG003","value":"12"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.29","spread":"9.15"},{"groupId":"OG001","value":"5.09","spread":"9.37"},{"groupId":"OG002","value":"16.79","spread":"6.21"},{"groupId":"OG003","value":"16.94","spread":"8.86"}]}]},{"title":"Day 48: predose","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"15"},{"groupId":"OG002","value":"10"},{"groupId":"OG003","value":"11"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-1.06","spread":"10.06"},{"groupId":"OG001","value":"7.20","spread":"5.88"},{"groupId":"OG002","value":"10.20","spread":"9.70"},{"groupId":"OG003","value":"17.06","spread":"6.12"}]}]},{"title":"Day 48: 6 hours postdose","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"15"},{"groupId":"OG002","value":"10"},{"groupId":"OG003","value":"11"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-6.25","spread":"10.34"},{"groupId":"OG001","value":"1.16","spread":"10.21"},{"groupId":"OG002","value":"15.43","spread":"12.15"},{"groupId":"OG003","value":"12.70","spread":"5.95"}]}]}]},{"type":"PRIMARY","title":"Number of Patients Who Experienced Adverse Events (AEs)","description":"AEs were collected from Day 1 of treatment up to 14 days after the last dose of IP. Serious AEs (SAEs) were collected from signing of informed consent. The numbers of patients who experienced any AE, any SAE (including events with an outcome of death), and any AE leading to discontinuation of IP are presented.","populationDescription":"The Safety Analysis Set included all randomised patients who received at least 1 dose of IP, analysed according to the treatment received.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Day 1 up to 14 days after the last dose of IP (approximately 9 weeks).","groups":[{"id":"OG000","title":"Placebo","description":"Patients were randomised to receive MEDI0382 matched placebo for 48 days."},{"id":"OG001","title":"MEDI0382 100 mcg","description":"Patients were randomised to receive 100 mcg MEDI0382 per day by SC injection, titrated as follows: 50 mcg/day for 5 days and then 100 mcg/day for 43 days."},{"id":"OG002","title":"MEDI0382 200 mcg","description":"Patients were randomised to receive 200 mcg MEDI0382 per day by SC injection, titrated as follows: 50 mcg/day for 5 days, 100 mcg/day for 7 days and then 200 mcg/day for 36 days."},{"id":"OG003","title":"MEDI0382 300 mcg","description":"Patients were randomised to receive 300 mcg MEDI0382 per day by SC injection, titrated as follows: 50 mcg/day for 5 days, 100 mcg/day for 7 days, 200 mcg/day for 7 days and then 300 mcg/day for 29 days."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"15"},{"groupId":"OG002","value":"15"},{"groupId":"OG003","value":"15"}]}],"classes":[{"title":"Any AE","categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"11"},{"groupId":"OG003","value":"9"}]}]},{"title":"Any SAE","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]},{"title":"Any AE leading to discontinuation of IP","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"4"},{"groupId":"OG003","value":"1"}]}]}]},{"type":"SECONDARY","title":"Mean Change From Baseline in HbA1c at Day 48","description":"The mean change from baseline in HbA1c at Day 48 was analysed using an ANCOVA model with treatment group as a factor and baseline as a covariate. For patients who prematurely discontinued IP, or for patients who did not have a measurement taken on Day 48, the last post-baseline measurement, regardless of rescue medication, was used (LOCF).","populationDescription":"The Full Analysis Set included all randomised patients who received at least 1 dose of IP, analysed according to their randomised treatment group. Patients with data available are presented.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"Percent glycated haemoglobin","timeFrame":"Baseline (Day -1) and Day 48 (predose).","groups":[{"id":"OG000","title":"Placebo","description":"Patients were randomised to receive MEDI0382 matched placebo for 48 days."},{"id":"OG001","title":"MEDI0382 100 mcg","description":"Patients were randomised to receive 100 mcg MEDI0382 per day by SC injection, titrated as follows: 50 mcg/day for 5 days and then 100 mcg/day for 43 days."},{"id":"OG002","title":"MEDI0382 200 mcg","description":"Patients were randomised to receive 200 mcg MEDI0382 per day by SC injection, titrated as follows: 50 mcg/day for 5 days, 100 mcg/day for 7 days and then 200 mcg/day for 36 days."},{"id":"OG003","title":"MEDI0382 300 mcg","description":"Patients were randomised to receive 300 mcg MEDI0382 per day by SC injection, titrated as follows: 50 mcg/day for 5 days, 100 mcg/day for 7 days, 200 mcg/day for 7 days and then 300 mcg/day for 29 days."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"15"},{"groupId":"OG002","value":"15"},{"groupId":"OG003","value":"15"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.14","lowerLimit":"-0.41","upperLimit":"0.12"},{"groupId":"OG001","value":"-1.23","lowerLimit":"-1.51","upperLimit":"-0.96"},{"groupId":"OG002","value":"-1.24","lowerLimit":"-1.53","upperLimit":"-0.96"},{"groupId":"OG003","value":"-0.90","lowerLimit":"-1.18","upperLimit":"-0.63"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Pair-wise comparison of MEDI0382 100 mcg versus Placebo.","nonInferiorityType":"OTHER","pValue":"<0.0001","statisticalMethod":"ANCOVA","statisticalComment":"Analysis used treatment group as a factor and baseline as a covariate.","paramType":"LS mean difference","paramValue":"-1.09","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.48","ciUpperLimit":"-0.70","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.19","estimateComment":"Treatment difference = MEDI0382 100 mcg - Placebo"},{"groupIds":["OG000","OG002"],"groupDescription":"Pair-wise comparison of MEDI0382 200 mcg versus Placebo.","nonInferiorityType":"OTHER","pValue":"<0.0001","statisticalMethod":"ANCOVA","statisticalComment":"Analysis used treatment group as a factor and baseline as a covariate.","paramType":"LS mean difference","paramValue":"-1.10","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.49","ciUpperLimit":"-0.71","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.19","estimateComment":"Treatment difference = MEDI0382 200 mcg - Placebo"},{"groupIds":["OG000","OG003"],"groupDescription":"Pair-wise comparison of MEDI0382 300 mcg versus Placebo.","nonInferiorityType":"OTHER","pValue":"0.0002","statisticalMethod":"ANCOVA","statisticalComment":"Analysis used treatment group as a factor and baseline as a covariate.","paramType":"LS mean difference","paramValue":"-0.76","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.15","ciUpperLimit":"-0.38","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.19","estimateComment":"Treatment difference = MEDI0382 300 mcg - Placebo"}]},{"type":"SECONDARY","title":"Mean Change From Baseline in Fasting Plasma Glucose at Day 48","description":"The mean change from baseline in fasting plasma glucose at Day 48 was analysed using an ANCOVA model with treatment group as a factor and baseline as a covariate. For patients who prematurely discontinued IP, or for patients who did not have a measurement taken on Day 48, the last post-baseline measurement, regardless of rescue medication, was used (LOCF).","populationDescription":"The Full Analysis Set included all randomised patients who received at least 1 dose of IP, analysed according to their randomised treatment group. Patients with data available are presented.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"milligrams per decilitre (mg/dL)","timeFrame":"Baseline (Day -1) and Day 48 (predose).","groups":[{"id":"OG000","title":"Placebo","description":"Patients were randomised to receive MEDI0382 matched placebo for 48 days."},{"id":"OG001","title":"MEDI0382 100 mcg","description":"Patients were randomised to receive 100 mcg MEDI0382 per day by SC injection, titrated as follows: 50 mcg/day for 5 days and then 100 mcg/day for 43 days."},{"id":"OG002","title":"MEDI0382 200 mcg","description":"Patients were randomised to receive 200 mcg MEDI0382 per day by SC injection, titrated as follows: 50 mcg/day for 5 days, 100 mcg/day for 7 days and then 200 mcg/day for 36 days."},{"id":"OG003","title":"MEDI0382 300 mcg","description":"Patients were randomised to receive 300 mcg MEDI0382 per day by SC injection, titrated as follows: 50 mcg/day for 5 days, 100 mcg/day for 7 days, 200 mcg/day for 7 days and then 300 mcg/day for 29 days."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"15"},{"groupId":"OG002","value":"15"},{"groupId":"OG003","value":"15"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.40","lowerLimit":"-12.60","upperLimit":"11.80"},{"groupId":"OG001","value":"-57.10","lowerLimit":"-69.77","upperLimit":"-44.42"},{"groupId":"OG002","value":"-60.98","lowerLimit":"-76.82","upperLimit":"-45.15"},{"groupId":"OG003","value":"-55.47","lowerLimit":"-70.28","upperLimit":"-40.66"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Pair-wise comparison of MEDI0382 100 mcg versus Placebo.","nonInferiorityType":"OTHER","pValue":"<0.0001","statisticalMethod":"ANCOVA","statisticalComment":"Analysis used treatment group as a factor and baseline as a covariate.","paramType":"LS mean difference","paramValue":"-56.69","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-74.30","ciUpperLimit":"-39.09","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"8.75","estimateComment":"Treatment difference = MEDI0382 100 mcg - Placebo"},{"groupIds":["OG000","OG002"],"groupDescription":"Pair-wise comparison of MEDI0382 200 mcg versus Placebo.","nonInferiorityType":"OTHER","pValue":"<0.0001","statisticalMethod":"ANCOVA","statisticalComment":"Analysis used treatment group as a factor and baseline as a covariate.","paramType":"LS mean difference","paramValue":"-60.58","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-80.53","ciUpperLimit":"-40.63","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"9.92","estimateComment":"Treatment difference = MEDI0382 200 mcg - Placebo"},{"groupIds":["OG000","OG003"],"groupDescription":"Pair-wise comparison of MEDI0382 300 mcg versus Placebo.","nonInferiorityType":"OTHER","pValue":"<0.0001","statisticalMethod":"ANCOVA","statisticalComment":"Analysis used treatment group as a factor and baseline as a covariate.","paramType":"LS mean difference","paramValue":"-55.07","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-74.28","ciUpperLimit":"-35.86","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"9.55","estimateComment":"Treatment difference = MEDI0382 300 mcg - Placebo"}]},{"type":"SECONDARY","title":"Mean Change From Baseline in Fructosamine at Day 48","description":"The mean change from baseline in fructosamine at Day 48 was analysed using an ANCOVA model with treatment group as a factor and baseline as a covariate. For patients who prematurely discontinued IP, the last on-treatment measurement, regardless of rescue medication, was used (LOCF).","populationDescription":"The Full Analysis Set included all randomised patients who received at least 1 dose of IP, analysed according to their randomised treatment group. Patients with data available are presented.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"millimoles per litre (mmol/L)","timeFrame":"Baseline (Day -1) and Day 48 (predose).","groups":[{"id":"OG000","title":"Placebo","description":"Patients were randomised to receive MEDI0382 matched placebo for 48 days."},{"id":"OG001","title":"MEDI0382 100 mcg","description":"Patients were randomised to receive 100 mcg MEDI0382 per day by SC injection, titrated as follows: 50 mcg/day for 5 days and then 100 mcg/day for 43 days."},{"id":"OG002","title":"MEDI0382 200 mcg","description":"Patients were randomised to receive 200 mcg MEDI0382 per day by SC injection, titrated as follows: 50 mcg/day for 5 days, 100 mcg/day for 7 days and then 200 mcg/day for 36 days."},{"id":"OG003","title":"MEDI0382 300 mcg","description":"Patients were randomised to receive 300 mcg MEDI0382 per day by SC injection, titrated as follows: 50 mcg/day for 5 days, 100 mcg/day for 7 days, 200 mcg/day for 7 days and then 300 mcg/day for 29 days."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"15"},{"groupId":"OG002","value":"15"},{"groupId":"OG003","value":"15"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.012","lowerLimit":"-0.029","upperLimit":"0.004"},{"groupId":"OG001","value":"-0.083","lowerLimit":"-0.100","upperLimit":"-0.066"},{"groupId":"OG002","value":"-0.066","lowerLimit":"-0.083","upperLimit":"-0.048"},{"groupId":"OG003","value":"-0.061","lowerLimit":"-0.079","upperLimit":"-0.044"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Pair-wise comparison of MEDI0382 100 mcg versus Placebo.","nonInferiorityType":"OTHER","pValue":"<0.0001","statisticalMethod":"ANCOVA","statisticalComment":"Analysis used treatment group as a factor and baseline as a covariate.","paramType":"LS mean difference","paramValue":"-0.071","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.094","ciUpperLimit":"-0.047","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.012","estimateComment":"Treatment difference = MEDI0382 100 mcg - Placebo"},{"groupIds":["OG000","OG002"],"groupDescription":"Pair-wise comparison of MEDI0382 200 mcg versus Placebo.","nonInferiorityType":"OTHER","pValue":"<0.0001","statisticalMethod":"ANCOVA","statisticalComment":"Analysis used treatment group as a factor and baseline as a covariate.","paramType":"LS mean difference","paramValue":"-0.053","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.077","ciUpperLimit":"-0.030","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.012","estimateComment":"Treatment difference = MEDI0382 200 mcg - Placebo"},{"groupIds":["OG000","OG003"],"groupDescription":"Pair-wise comparison of MEDI0382 300 mcg versus Placebo.","nonInferiorityType":"OTHER","pValue":"0.0002","statisticalMethod":"ANCOVA","statisticalComment":"Analysis used treatment group as a factor and baseline as a covariate.","paramType":"LS mean difference","paramValue":"-0.049","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.074","ciUpperLimit":"-0.024","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.012","estimateComment":"Treatment difference = MEDI0382 300 mcg - Placebo"}]},{"type":"SECONDARY","title":"Mean Change From Baseline in the Percentage of Time in Hyperglycaemia Over 24 Hours at Days 5, 12, 19 and 47","description":"Hyperglycaemia was defined as blood glucose \\>7.8 mmol/L or \\>140 mg/dL. Continuous glucose monitoring used a device fitted to the upper arm by trained study site staff to measure and record interstitial glucose levels every 15 minutes. Analysis was based on 24-hour readings defined as the first available time point with a valid continuous glucose monitoring glucose reading. The change in the percentage time in hyperglycaemia from the last day of baseline continuous glucose monitoring over 24 hours to the end of dosing at each dose level for the indicated timepoints is presented.","populationDescription":"The Full Analysis Set included all randomised patients who received at least 1 dose of IP, analysed according to their randomised treatment group. Patients with data available at each time point are presented.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage of time","timeFrame":"Baseline (Day -8 to -2) and Days 5, 12, 19 and 47.","groups":[{"id":"OG000","title":"Placebo","description":"Patients were randomised to receive MEDI0382 matched placebo for 48 days."},{"id":"OG001","title":"MEDI0382 100 mcg","description":"Patients were randomised to receive 100 mcg MEDI0382 per day by SC injection, titrated as follows: 50 mcg/day for 5 days and then 100 mcg/day for 43 days."},{"id":"OG002","title":"MEDI0382 200 mcg","description":"Patients were randomised to receive 200 mcg MEDI0382 per day by SC injection, titrated as follows: 50 mcg/day for 5 days, 100 mcg/day for 7 days and then 200 mcg/day for 36 days."},{"id":"OG003","title":"MEDI0382 300 mcg","description":"Patients were randomised to receive 300 mcg MEDI0382 per day by SC injection, titrated as follows: 50 mcg/day for 5 days, 100 mcg/day for 7 days, 200 mcg/day for 7 days and then 300 mcg/day for 29 days."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"15"},{"groupId":"OG002","value":"15"},{"groupId":"OG003","value":"15"}]}],"classes":[{"title":"Day 5","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"15"},{"groupId":"OG002","value":"13"},{"groupId":"OG003","value":"7"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-3.23","spread":"12.59"},{"groupId":"OG001","value":"-48.35","spread":"21.27"},{"groupId":"OG002","value":"-33.71","spread":"24.67"},{"groupId":"OG003","value":"-51.33","spread":"30.04"}]}]},{"title":"Day 12","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"14"},{"groupId":"OG002","value":"10"},{"groupId":"OG003","value":"8"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-11.72","spread":"28.58"},{"groupId":"OG001","value":"-57.74","spread":"24.59"},{"groupId":"OG002","value":"-53.36","spread":"21.59"},{"groupId":"OG003","value":"-55.78","spread":"25.19"}]}]},{"title":"Day 19","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"14"},{"groupId":"OG002","value":"12"},{"groupId":"OG003","value":"9"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-12.08","spread":"17.61"},{"groupId":"OG001","value":"-59.57","spread":"16.98"},{"groupId":"OG002","value":"-43.85","spread":"28.96"},{"groupId":"OG003","value":"-60.68","spread":"24.93"}]}]},{"title":"Day 47","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"15"},{"groupId":"OG002","value":"9"},{"groupId":"OG003","value":"6"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-6.15","spread":"22.80"},{"groupId":"OG001","value":"-47.99","spread":"20.63"},{"groupId":"OG002","value":"-48.96","spread":"20.28"},{"groupId":"OG003","value":"-57.59","spread":"21.86"}]}]}]},{"type":"SECONDARY","title":"Mean Change From Baseline in the Percentage of Time in Hypoglycaemia Over 24 Hours at Days 5, 12, 19 and 47","description":"Hypoglycaemia was defined as blood glucose \\<3 mmol/L or \\<54 mg/dL. Continuous glucose monitoring used a device fitted to the upper arm by trained study site staff to measure and record interstitial glucose levels every 15 minutes. Analysis was based on 24-hour readings defined as the first available time point with a valid continuous glucose monitoring glucose reading. The change in the percentage time in hypoglycaemia from the last day of baseline continuous glucose monitoring over 24 hours to the end of dosing at each dose level for the timepoints is presented.","populationDescription":"The Full Analysis Set included all randomised patients who received at least 1 dose of IP, analysed according to their randomised treatment group. Patients with data available at each time point are presented.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage of time","timeFrame":"Baseline (Day -8 to -2) and Days 5, 12, 19 and 47.","groups":[{"id":"OG000","title":"Placebo","description":"Patients were randomised to receive MEDI0382 matched placebo for 48 days."},{"id":"OG001","title":"MEDI0382 100 mcg","description":"Patients were randomised to receive 100 mcg MEDI0382 per day by SC injection, titrated as follows: 50 mcg/day for 5 days and then 100 mcg/day for 43 days."},{"id":"OG002","title":"MEDI0382 200 mcg","description":"Patients were randomised to receive 200 mcg MEDI0382 per day by SC injection, titrated as follows: 50 mcg/day for 5 days, 100 mcg/day for 7 days and then 200 mcg/day for 36 days."},{"id":"OG003","title":"MEDI0382 300 mcg","description":"Patients were randomised to receive 300 mcg MEDI0382 per day by SC injection, titrated as follows: 50 mcg/day for 5 days, 100 mcg/day for 7 days, 200 mcg/day for 7 days and then 300 mcg/day for 29 days."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"15"},{"groupId":"OG002","value":"15"},{"groupId":"OG003","value":"15"}]}],"classes":[{"title":"Day 5","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"15"},{"groupId":"OG002","value":"13"},{"groupId":"OG003","value":"7"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.00","spread":"0.00"},{"groupId":"OG001","value":"0.00","spread":"0.00"},{"groupId":"OG002","value":"0.00","spread":"0.00"},{"groupId":"OG003","value":"6.28","spread":"16.61"}]}]},{"title":"Day 12","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"14"},{"groupId":"OG002","value":"10"},{"groupId":"OG003","value":"8"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.00","spread":"0.00"},{"groupId":"OG001","value":"0.00","spread":"0.00"},{"groupId":"OG002","value":"0.00","spread":"0.00"},{"groupId":"OG003","value":"0.00","spread":"0.00"}]}]},{"title":"Day 19","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"14"},{"groupId":"OG002","value":"12"},{"groupId":"OG003","value":"9"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.00","spread":"0.00"},{"groupId":"OG001","value":"0.00","spread":"0.00"},{"groupId":"OG002","value":"3.68","spread":"12.75"},{"groupId":"OG003","value":"0.00","spread":"0.00"}]}]},{"title":"Day 47","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"15"},{"groupId":"OG002","value":"9"},{"groupId":"OG003","value":"6"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.00","spread":"0.00"},{"groupId":"OG001","value":"0.00","spread":"0.00"},{"groupId":"OG002","value":"0.00","spread":"0.00"},{"groupId":"OG003","value":"0.00","spread":"0.00"}]}]}]},{"type":"SECONDARY","title":"Mean Change From Baseline in the Percentage of Time in Hyperglycaemia Over 5 Days for 50 mcg Dose Level and 7 Days for Other Dose Levels","description":"Hyperglycaemia was defined as blood glucose \\>7.8 mmol/L or \\>140 mg/dL. Continuous glucose monitoring used a device fitted to the upper arm by trained study site staff to measure and record interstitial glucose levels every 15 minutes. Analysis was based on 24-hour readings defined as the first available time point with a valid continuous glucose monitoring glucose reading. The change in the percentage time in hyperglycaemia from the last day of baseline continuous glucose monitoring over 5 days for 50 mcg MEDI0382 and 7 days for each of the dose levels (during titration) is presented, up to Day 47, per randomised group.","populationDescription":"The Full Analysis Set included all randomised patients who received at least 1 dose of IP, analysed according to their randomised treatment group. Patients with data available at each time point are presented.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage of time","timeFrame":"Baseline (Day -8 to -2) and Days 1 to 5, 6 to 12, 13 to 19 and 41 to 47.","groups":[{"id":"OG000","title":"Placebo","description":"Patients were randomised to receive MEDI0382 matched placebo for 48 days."},{"id":"OG001","title":"MEDI0382 100 mcg","description":"Patients were randomised to receive 100 mcg MEDI0382 per day by SC injection, titrated as follows: 50 mcg/day for 5 days and then 100 mcg/day for 43 days."},{"id":"OG002","title":"MEDI0382 200 mcg","description":"Patients were randomised to receive 200 mcg MEDI0382 per day by SC injection, titrated as follows: 50 mcg/day for 5 days, 100 mcg/day for 7 days and then 200 mcg/day for 36 days."},{"id":"OG003","title":"MEDI0382 300 mcg","description":"Patients were randomised to receive 300 mcg MEDI0382 per day by SC injection, titrated as follows: 50 mcg/day for 5 days, 100 mcg/day for 7 days, 200 mcg/day for 7 days and then 300 mcg/day for 29 days."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"15"},{"groupId":"OG002","value":"15"},{"groupId":"OG003","value":"15"}]}],"classes":[{"title":"Days 1 to 5","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"14"},{"groupId":"OG002","value":"12"},{"groupId":"OG003","value":"9"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-1.43","spread":"10.26"},{"groupId":"OG001","value":"-42.52","spread":"13.46"},{"groupId":"OG002","value":"-38.68","spread":"18.97"},{"groupId":"OG003","value":"-34.74","spread":"18.24"}]}]},{"title":"Days 6 to 12","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"15"},{"groupId":"OG002","value":"10"},{"groupId":"OG003","value":"9"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-8.97","spread":"26.12"},{"groupId":"OG001","value":"-48.35","spread":"16.01"},{"groupId":"OG002","value":"-50.81","spread":"18.97"},{"groupId":"OG003","value":"-51.82","spread":"16.73"}]}]},{"title":"Days 13 to 19","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"15"},{"groupId":"OG002","value":"12"},{"groupId":"OG003","value":"10"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-6.09","spread":"19.10"},{"groupId":"OG001","value":"-53.25","spread":"16.47"},{"groupId":"OG002","value":"-52.33","spread":"20.96"},{"groupId":"OG003","value":"-47.50","spread":"20.67"}]}]},{"title":"Days 41 to 47","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"15"},{"groupId":"OG002","value":"10"},{"groupId":"OG003","value":"8"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.40","spread":"22.70"},{"groupId":"OG001","value":"-42.37","spread":"17.22"},{"groupId":"OG002","value":"-43.44","spread":"18.26"},{"groupId":"OG003","value":"-51.25","spread":"17.12"}]}]}]},{"type":"SECONDARY","title":"Mean Change From Baseline in the Percentage of Time in Hypoglycaemia Over 5 Days for 50 mcg Dose Level and 7 Days for Other Dose Levels","description":"Hyp0glycaemia was defined as blood glucose \\<3 mmol/L or \\<54 mg/dL. Continuous glucose monitoring used a device fitted to the upper arm by trained study site staff to measure and record interstitial glucose levels every 15 minutes. Analysis was based on 24-hour readings defined as the first available time point with a valid continuous glucose monitoring glucose reading. The change in the percentage time in hypoglycaemia from the last day of baseline continuous glucose monitoring over 5 days for 50 mcg MEDI0382 and 7 days for each of the randomised dose levels (during titration) is presented, up to Day 47, per randomised group.","populationDescription":"The Full Analysis Set included all randomised patients who received at least 1 dose of IP, analysed according to their randomised treatment group. Patients with data available at each time point are presented.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage of time","timeFrame":"Baseline (Day -8 to -2) and Days 1 to 5, 6 to 12, 13 to 19 and 41 to 47.","groups":[{"id":"OG000","title":"Placebo","description":"Patients were randomised to receive MEDI0382 matched placebo for 48 days."},{"id":"OG001","title":"MEDI0382 100 mcg","description":"Patients were randomised to receive 100 mcg MEDI0382 per day by SC injection, titrated as follows: 50 mcg/day for 5 days and then 100 mcg/day for 43 days."},{"id":"OG002","title":"MEDI0382 200 mcg","description":"Patients were randomised to receive 200 mcg MEDI0382 per day by SC injection, titrated as follows: 50 mcg/day for 5 days, 100 mcg/day for 7 days and then 200 mcg/day for 36 days."},{"id":"OG003","title":"MEDI0382 300 mcg","description":"Patients were randomised to receive 300 mcg MEDI0382 per day by SC injection, titrated as follows: 50 mcg/day for 5 days, 100 mcg/day for 7 days, 200 mcg/day for 7 days and then 300 mcg/day for 29 days."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"15"},{"groupId":"OG002","value":"15"},{"groupId":"OG003","value":"15"}]}],"classes":[{"title":"Days 1 to 5","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"14"},{"groupId":"OG002","value":"12"},{"groupId":"OG003","value":"9"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.21","spread":"0.76"},{"groupId":"OG001","value":"0.06","spread":"0.27"},{"groupId":"OG002","value":"0.25","spread":"0.55"},{"groupId":"OG003","value":"5.50","spread":"16.57"}]}]},{"title":"Days 6 to 12","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"15"},{"groupId":"OG002","value":"10"},{"groupId":"OG003","value":"9"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.06","spread":"0.22"},{"groupId":"OG001","value":"0.90","spread":"2.24"},{"groupId":"OG002","value":"0.07","spread":"0.19"},{"groupId":"OG003","value":"0.13","spread":"0.62"}]}]},{"title":"Days 13 to 19","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"15"},{"groupId":"OG002","value":"12"},{"groupId":"OG003","value":"10"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.10","spread":"0.30"},{"groupId":"OG001","value":"0.41","spread":"1.25"},{"groupId":"OG002","value":"2.97","spread":"5.43"},{"groupId":"OG003","value":"1.09","spread":"1.58"}]}]},{"title":"Days 41 to 47","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"15"},{"groupId":"OG002","value":"10"},{"groupId":"OG003","value":"8"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.01","spread":"0.04"},{"groupId":"OG001","value":"-0.02","spread":"0.05"},{"groupId":"OG002","value":"0.30","spread":"0.60"},{"groupId":"OG003","value":"2.59","spread":"7.22"}]}]}]},{"type":"SECONDARY","title":"Mean Trough Plasma Concentration (Ctrough) of MEDI0382 up to Day 48","description":"To evaluate pharmacokinetics (PK), blood samples were collected predose and Ctrough of MEDI0382 was determined. Results are presented for Days 2, 5, 34 and 48.","populationDescription":"The PK Analysis Set included all patients who received at least 1 dose of MEDI0382 and had at least 1 post-baseline MEDI0382 PK sample taken that was above the lower limit of quantification. Patients with data available at each timepoint are presented.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"nanograms per millilitre","timeFrame":"Blood samples collected predose on Days 1 to 6, 13, 20, 34 and 48.","groups":[{"id":"OG000","title":"MEDI0382 100 mcg","description":"Patients were randomised to receive 100 mcg MEDI0382 per day by SC injection, titrated as follows: 50 mcg/day for 5 days and then 100 mcg/day for 43 days."},{"id":"OG001","title":"MEDI0382 200 mcg","description":"Patients were randomised to receive 200 mcg MEDI0382 per day by SC injection, titrated as follows: 50 mcg/day for 5 days, 100 mcg/day for 7 days and then 200 mcg/day for 36 days."},{"id":"OG002","title":"MEDI0382 300 mcg","description":"Patients were randomised to receive 300 mcg MEDI0382 per day by SC injection, titrated as follows: 50 mcg/day for 5 days, 100 mcg/day for 7 days, 200 mcg/day for 7 days and then 300 mcg/day for 29 days."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"15"},{"groupId":"OG002","value":"15"}]}],"classes":[{"title":"Day 2","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"15"},{"groupId":"OG002","value":"15"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.20","spread":"41.8"},{"groupId":"OG001","value":"1.22","spread":"22.9"},{"groupId":"OG002","value":"1.11","spread":"26.9"}]}]},{"title":"Day 5","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"14"},{"groupId":"OG002","value":"14"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.47","spread":"36.8"},{"groupId":"OG001","value":"1.61","spread":"26.6"},{"groupId":"OG002","value":"1.56","spread":"25.8"}]}]},{"title":"Day 34","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"11"},{"groupId":"OG002","value":"11"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"2.70","spread":"78.0"},{"groupId":"OG001","value":"5.16","spread":"81.4"},{"groupId":"OG002","value":"7.18","spread":"39.8"}]}]},{"title":"Day 48","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"10"},{"groupId":"OG002","value":"11"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"2.83","spread":"77.5"},{"groupId":"OG001","value":"7.14","spread":"23.8"},{"groupId":"OG002","value":"9.12","spread":"24.7"}]}]}]},{"type":"SECONDARY","title":"Number of Patients With Antidrug Antibody (ADA) Response to MEDI0382","description":"The number of patients who were ADA positive at baseline and/or post-baseline are presented. Persistent positive was defined as positive at ≥2 post-baseline assessments (with ≥16 weeks between first and last positive) or positive at the last post-baseline assessment. 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for 5 days, 100 mcg/day for 7 days and then 200 mcg/day for 36 days."},{"id":"OG002","title":"MEDI0382 300 mcg","description":"Patients were randomised to receive 300 mcg MEDI0382 per day by SC injection, titrated as follows: 50 mcg/day for 5 days, 100 mcg/day for 7 days, 200 mcg/day for 7 days and then 300 mcg/day for 29 days."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"15"},{"groupId":"OG002","value":"15"}]}],"classes":[{"title":"ADA +ve at baseline","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"title":"ADA +ve post-baseline","categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"2"}]}]},{"title":"ADA +ve post-baseline & +ve at 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