A Study to Look at the Effect MEDI0382 Has on Blood Sugar... | NCT03550378

ID	Type	Description	Link
2018-000019-26	EudraCT Number

Label	Type	Description	Intervention Names
MEDI0382	Experimental	Participants will receive subcutaneous (SC) dose of MEDI0382 titrated from 50 μg upto 300 μg (50 μg once daily for 4 days, followed by 100 μg daily for 7 days, 200 μg daily for 7 days, and 300 μg daily for 14 days) for 32 days.	Drug: MEDI0382
Placebo	Placebo Comparator	Participants will receive SC dose of placebo matched to MEDI0382 once daily for 32 days.	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
MEDI0382	Drug	Participants will receive subcutaneous MEDI0382 titrated from 50 μg upto 300 μg (50 μg once daily for 4 days, followed by 100 μg daily for 7 days, 200 μg daily for 7 days, and 300 μg daily for 14 days) for 32 days.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥ 18 and < 85 years at screening.
Signed and dated written informed consent (with the exception of consent for genetic and nongenetic research) prior to performing any protocol-related procedures, including screening evaluations.
Diagnosed with type 2 diabetes mellitus (T2DM) with glucose control managed with any insulin and/or oral therapy combination where no significant dose changes of oral therapy of more than 50% have occurred in the 3 months prior to screening
Body mass index (BMI) between 25 and 45 kg/m^2 (inclusive) at screening
Haemoglobin A1c (HbA1c) range of 6.5 % to 10.5% (inclusive) at screening
Renal impairment with estimated glomerular filtration rate (eGFR) ≥ 30 and < 60 mL/min/1.73 m^2 at screening. Approximately 16 participants (40%) are required to have a screening eGFR ≥30 and < 45 mL/min/1.73 m^2 and at least 16 participants (40%) are required to have screening eGFR ≥45 and < 60 mL/min/1.73 m^2.
Females of childbearing potential must have a negative pregnancy test at screening and randomisation, and must not be lactating. Women of childbearing potential who are sexually active with a non-sterilized male partner must be using at least one highly effective method of contraception from screening and up to 4 weeks after the last dose study drug.

Exclusion Criteria:

History or presence of significant medical or psychological conditions, including substance dependence/abuse, or significant abnormalities in laboratory parameters or vital signs including electrocardiogram (ECG), which in the opinion of the investigator, would compromise the participant's safety or successful participation in the study. As an example, severe anaemia (haemoglobin < 7.0 g/dL) could be exclusionary due to blood sampling required by the protocol, at the discretion of investigator.
Concurrent participation in another interventional study of any kind and repeat randomisation in this study is prohibited.
Any participant who has received another study drug as part of a clinical study or a glucagon-like peptide-1 (GLP-1) analogue-containing preparation within the last 30 days or 5 half-lives of the drug (if known; whichever is longer) at the time of Visit 2.
Any participant who has received any of the following medications within the specified timeframe prior to the start of the study (Visit 2)
- Herbal preparations within 1 week prior to the start of dosing (Visit 4) or drugs licensed for control of body weight or appetite (eg, orlistat, bupropion-naltrexone, phentermine-topiramate, phentermine, lorcaserin) within 30 days (or 5 half-lives of the drug) prior to the start of dosing (Visit 4)
- Aspirin (acetylsalicylic acid) at a dose greater than 150 mg once daily and within the last 3 days prior to the start of the run-in period (Visit 2)
- Paracetamol (acetaminophen) or paracetamol-containing preparations at a total daily dose of greater than 3000 mg and within the last 3 days prior to the start of the run-in period (Visit 2)
- Ascorbic acid (vitamin C) supplements at a total daily dose of greater than 1000 mg and within the last 3 days prior to the start of the run-in period (Visit 2)
- Opiates, domperidone, metoclopramide, or other drugs known to alter gastric emptying and within 2 weeks prior to the start of dosing (Visit 4)
Severe allergy/hypersensitivity to any of the proposed study treatments or excipients
Symptoms of acutely decompensated blood glucose control (eg, thirst, polyuria, weight loss), a history of type 1 diabetes mellitus or diabetic ketoacidosis
Participants who have undergone a renal transplant
Participants with suspicion of acute or subacute renal function deterioration (eg, participants with large fluctuations of creatinine values documented within the 6 months prior to screening)
Significant inflammatory bowel disease, gastroparesis, or other severe disease or surgery affecting the upper gastrointestinal (GI) tract including weight-reducing surgery and procedures) which may affect gastric emptying or could affect the interpretation of safety and tolerability data
History of acute or chronic pancreatitis
Significant hepatic disease (except for non-alcoholic steatohepatitis or nonalcoholic fatty liver disease without portal hypertension or cirrhosis) and/or participants with any of the following results:
- Aspartate transaminase (AST) ≥ 3 × upper limit of normal (ULN)
- Alanine transaminase (ALT) ≥ 3 × ULN
- Total bilirubin ≥ 2 × ULN
Poorly controlled hypertension defined as:
- Systolic blood pressure (BP) > 180 mm Hg
- Diastolic BP ≥ 100 mm Hg Participants who fail BP screening criteria may be considered for 24-hour ambulatory blood pressure monitoring (ABPM) at the discretion of the investigator. Participants who maintain a mean 24-hour systolic BP ≤ 180 or diastolic BP < 100 mm Hg with a preserved nocturnal dip of > 15% will be considered eligible
Unstable angina pectoris, myocardial infarction, transient ischemic attack or stroke within 3 months prior to screening, or participants who have undergone percutaneous coronary intervention or a coronary artery bypass graft within the past 6 months or who are due to undergo these procedures at the time of screening
Severe congestive heart failure (New York Heart Association Class III or IV)
Basal calcitonin level > 50 ng/L at screening or history/family history of medullary thyroid carcinoma or multiple endocrine neoplasia
History of neoplastic disease within 5 years prior to screening, except for adequately treated basal cell skin cancer, squamous cell skin cancer, or in situ cervical cancer
Any positive results for serum hepatitis B surface antigen (HBsAg), hepatitis C antibody, and human immunodeficiency virus (HIV) antibody
Nephrotic range proteinuria defined as spot urine albumin creatinine ratio (ACR) > 250 mg/mmol at screening
History of substance dependence, alcohol abuse, or excessive alcohol intake (defined as an average weekly intake of > 21 alcoholic drinks for men or > 10 alcoholic drinks for women) within 3 years prior to screening, and/or a positive screen for drugs of abuse or alcohol at screening or on Day -5. Participants who use tricyclic antidepressants or benzodiazepines for an established clinical indication may be permitted to enter the study based upon the judgement of the investigator

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Berlin		10117	Germany
Research Site

PubMed Identifier	Type	Citation	Retractions
39963952	Derived	Natale P, Green SC, Tunnicliffe DJ, Pellegrino G, Toyama T, Strippoli GF. Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2025 Feb 18;2(2):CD015849. doi: 10.1002/14651858.CD015849.pub2.
35403793	Derived	Parker VER, Hoang T, Schlichthaar H, Gibb FW, Wenzel B, Posch MG, Rose L, Chang YT, Petrone M, Hansen L, Ambery P, Jermutus L, Heerspink HJL, McCrimmon RJ. Efficacy and safety of cotadutide, a dual glucagon-like peptide-1 and glucagon receptor agonist, in a randomized phase 2a study of patients with type 2 diabetes and chronic kidney disease. Diabetes Obes Metab. 2022 Jul;24(7):1360-1369. doi: 10.1111/dom.14712. Epub 2022 Apr 25.

Label	URL
D5670C00013 CSP redacted	View source

ID	Title	Description
FG000	Placebo	Participants received subcutaneous dose (SC) of placebo matched to MEDI0382 once daily for 32 days.
FG001	MEDI0382	Participants received SC dose of MEDI0382 titrated from 50 μg upto 300 μg (50 μg once daily for 4 days, followed by 100 μg daily for 7 days, 200 μg daily for 7 days, and 300 μg daily for 14 days) for 32 days.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Nov 12, 2018	Nov 13, 2019

ID	Title	Description
BG000	Placebo	Participants received subcutaneous dose (SC) of placebo matched to MEDI0382 once daily for 32 days.
BG001	MEDI0382	Participants received SC dose of MEDI0382 titrated from 50 μg upto 300 μg (50 μg once daily for 4 days, followed by 100 μg daily for 7 days, 200 μg daily for 7 days, and 300 μg daily for 14 days) for 32 days.
BG002	Total	Total of all reporting groups

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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).

Intent-to-treat (ITT) population included all participants who received any dose of study drug and analyzed according to their randomized treatment group. Here, "N" signifies only the participants with available data were analyzed for the outcome measure.

Posted

Least Squares Mean

90% Confidence Interval

Percent change in plasma glucose

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

ID	Title	Description
OG000	Placebo	Participants received subcutaneous dose (SC) of placebo matched to MEDI0382 once daily for 32 days.
OG001	MEDI0382	Participants received SC dose of MEDI0382 titrated from 50 μg upto 300 μg (50 μg once daily for 4 days, followed by 100 μg daily for 7 days, 200 μg daily for 7 days, and 300 μg daily for 14 days) for 32 days.

Units	Counts
Participants	OG00020 OG00118

Title

Denominators

Categories

Title	Measurements
	OG0003.678(-3.793 to 11.149) OG001-26.706(-34.584 to -18.828)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		ANCOVA		<0.001		LS Mean Difference	-30.384			2-Sided	90	-41.270	-19.498					Superiority

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.

As-treated population included all participants who received any dose of study drug and analyzed according to the treatment they actually received.

Posted

Count of Participants

Participants

Day 1 through Day 60

ID	Title	Description
OG000	Placebo	Participants received subcutaneous dose (SC) of placebo matched to MEDI0382 once daily for 32 days.
OG001	MEDI0382	Participants received SC dose of MEDI0382 titrated from 50 μg upto 300 μg (50 μg once daily for 4 days, followed by 100 μg daily for 7 days, 200 μg daily for 7 days, and 300 μg daily for 14 days) for 32 days.

Secondary

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).

As-treated population included all participants who received any dose of study drug and analyzed according to the treatment they actually received.

Posted

Count of Participants

Participants

Day 1 through Day 60

ID	Title	Description
OG000	Placebo	Participants received subcutaneous dose (SC) of placebo matched to MEDI0382 once daily for 32 days.
OG001	MEDI0382	Participants received SC dose of MEDI0382 titrated from 50 μg upto 300 μg (50 μg once daily for 4 days, followed by 100 μg daily for 7 days, 200 μg daily for 7 days, and 300 μg daily for 14 days) for 32 days.

Units	Counts
Participants

Secondary

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.

As-treated population included all participants who received any dose of study drug and analyzed according to the treatment they actually received. Participants with difference (standing-supine) in DBP or SBP on Day 1 and the participants with difference (standing-supine) in DBP or SBP on Day 32 were analyzed.

Posted

Mean

Standard Deviation

mmHg

Baseline (Day 1) through Day 32

ID	Title	Description
OG000	Placebo	Participants received subcutaneous dose (SC) of placebo matched to MEDI0382 once daily for 32 days.
OG001	MEDI0382	Participants received SC dose of MEDI0382 titrated from 50 μg upto 300 μg (50 μg once daily for 4 days, followed by 100 μg daily for 7 days, 200 μg daily for 7 days, and 300 μg daily for 14 days) for 32 days.

Secondary

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.

As-treated population included all participants who received any dose of study drug and analyzed according to the treatment they actually received.

Posted

Count of Participants

Participants

Day 1 through Day 60

ID	Title	Description
OG000	Placebo	Participants received subcutaneous dose (SC) of placebo matched to MEDI0382 once daily for 32 days.
OG001	MEDI0382	Participants received SC dose of MEDI0382 titrated from 50 μg upto 300 μg (50 μg once daily for 4 days, followed by 100 μg daily for 7 days, 200 μg daily for 7 days, and 300 μg daily for 14 days) for 32 days.

Units	Counts
Participants

Secondary

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.

As-treated population included all participants who received any dose of study drug and analyzed according to the treatment they actually received.

Posted

Count of Participants

Participants

Day 1 through Day 60

ID	Title	Description
OG000	Placebo	Participants received subcutaneous dose (SC) of placebo matched to MEDI0382 once daily for 32 days.
OG001	MEDI0382	Participants received SC dose of MEDI0382 titrated from 50 μg upto 300 μg (50 μg once daily for 4 days, followed by 100 μg daily for 7 days, 200 μg daily for 7 days, and 300 μg daily for 14 days) for 32 days.

Units	Counts
Participants

Secondary

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.

As-treated population included all participants who received any dose of study drug and analyzed according to the treatment they actually received.

Posted

Count of Participants

Participants

Day 1 through Day 60

ID	Title	Description
OG000	Placebo	Participants received subcutaneous dose (SC) of placebo matched to MEDI0382 once daily for 32 days.
OG001	MEDI0382	Participants received SC dose of MEDI0382 titrated from 50 μg upto 300 μg (50 μg once daily for 4 days, followed by 100 μg daily for 7 days, 200 μg daily for 7 days, and 300 μg daily for 14 days) for 32 days.

Units	Counts
Participants

Secondary

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.

As-treated population included all participants who received any dose of study drug and analyzed according to the treatment they actually received. Here, "n" signifies only the participants with available data were analyzed for the specified time points.

Posted

Mean

Standard Deviation

Beats/min

Day -5 (Baseline) and on Days 5, 12, 19, and 32

ID	Title	Description
OG000	Placebo	Participants received subcutaneous dose (SC) of placebo matched to MEDI0382 once daily for 32 days.
OG001	MEDI0382	Participants received SC dose of MEDI0382 titrated from 50 μg upto 300 μg (50 μg once daily for 4 days, followed by 100 μg daily for 7 days, 200 μg daily for 7 days, and 300 μg daily for 14 days) for 32 days.

Units	Counts
Participants

Secondary

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.

Posted

Mean

Standard Deviation

mmHg

Day -5 (Baseline) and on Days 5, 12, 19, and 32

ID	Title	Description
OG000	Placebo	Participants received subcutaneous dose (SC) of placebo matched to MEDI0382 once daily for 32 days.
OG001	MEDI0382	Participants received SC dose of MEDI0382 titrated from 50 μg upto 300 μg (50 μg once daily for 4 days, followed by 100 μg daily for 7 days, 200 μg daily for 7 days, and 300 μg daily for 14 days) for 32 days.

Units	Counts
Participants

Secondary

Change From Baseline in Haemoglobin A1c (HbA1c) to Day 32

Change from baseline in haemoglobin A1c (HbA1c) is reported.

Posted

Least Squares Mean

90% Confidence Interval

Percent

Day 1 (Baseline) and Day 32

ID	Title	Description
OG000	Placebo	Participants received subcutaneous dose (SC) of placebo matched to MEDI0382 once daily for 32 days.
OG001	MEDI0382	Participants received SC dose of MEDI0382 titrated from 50 μg upto 300 μg (50 μg once daily for 4 days, followed by 100 μg daily for 7 days, 200 μg daily for 7 days, and 300 μg daily for 14 days) for 32 days.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Fasting Glucose to Day 32

Change from baseline in fasting glucose is reported.

An ITT population included all participants who received any dose of study drug and analyzed according to their randomized treatment group. Here, "N" signifies only the participants with available data were analyzed for the outcome measure.

Posted

Least Squares Mean

90% Confidence Interval

mg/dL

Day 1 (Baseline) and Day 32

ID	Title	Description
OG000	Placebo	Participants received subcutaneous dose (SC) of placebo matched to MEDI0382 once daily for 32 days.
OG001	MEDI0382	Participants received SC dose of MEDI0382 titrated from 50 μg upto 300 μg (50 μg once daily for 4 days, followed by 100 μg daily for 7 days, 200 μg daily for 7 days, and 300 μg daily for 14 days) for 32 days.

Units	Counts
Participants	OG000

Secondary

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).

An ITT population included all participants who received any dose of study drug and analyzed according to their randomized treatment group. Here, "n" signifies only the participants with available data were analyzed for the specified time points.

Posted

Least Squares Mean

90% Confidence Interval

Percentage of time

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)

ID	Title	Description
OG000	Placebo	Participants received subcutaneous dose (SC) of placebo matched to MEDI0382 once daily for 32 days.
OG001	MEDI0382	Participants received SC dose of MEDI0382 titrated from 50 μg upto 300 μg (50 μg once daily for 4 days, followed by 100 μg daily for 7 days, 200 μg daily for 7 days, and 300 μg daily for 14 days) for 32 days.

Units	Counts

Secondary

Percent Change Frome Baseline in Body Weight to Day 33

Percent change from baseline in body weight is reported.

Posted

Least Squares Mean

90% Confidence Interval

Percent change in body weight

Day 1 (Baseline) and Day 33

ID	Title	Description
OG000	Placebo	Participants received subcutaneous dose (SC) of placebo matched to MEDI0382 once daily for 32 days.
OG001	MEDI0382	Participants received SC dose of MEDI0382 titrated from 50 μg upto 300 μg (50 μg once daily for 4 days, followed by 100 μg daily for 7 days, 200 μg daily for 7 days, and 300 μg daily for 14 days) for 32 days.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Absolute Body Weight to Day 33

Change from baseline in absolute body weight is reported.

Posted

Mean

Standard Deviation

Day 1 (Baseline) and Day 33

ID	Title	Description
OG000	Placebo	Participants received subcutaneous dose (SC) of placebo matched to MEDI0382 once daily for 32 days.
OG001	MEDI0382	Participants received SC dose of MEDI0382 titrated from 50 μg upto 300 μg (50 μg once daily for 4 days, followed by 100 μg daily for 7 days, 200 μg daily for 7 days, and 300 μg daily for 14 days) for 32 days.

Units	Counts
Participants	OG000

Secondary

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.

Pharmacokinetic (PK) population included all participants who received at least 1 dose of study drug and had at least one PK sample collected with a value above the lower limit of quantitation.

Posted

Geometric Mean

Full Range

ng.hr/mL

Predose and at 0.5, 1, 2, 4, 6, 8, and 24 hrs postdose on Day 32

ID	Title	Description
OG000	MEDI0382	Participants received SC dose of MEDI0382 titrated from 50 μg upto 300 μg (50 μg once daily for 4 days, followed by 100 μg daily for 7 days, 200 μg daily for 7 days, and 300 μg daily for 14 days) for 32 days.

Units	Counts
Participants	OG000

Secondary

Maximum Observed Serum Concentration (Cmax) of MEDI0382 at 300 μg

Maximum observed serum concentration (Cmax) of MEDI0382 at 300 μg is reported.

The PK population included all participants who received at least 1 dose of study drug and had at least one PK sample collected with a value above the lower limit of quantitation.

Posted

Geometric Mean

Full Range

ng/mL

Predose and at 0.5, 1, 2, 4, 6, 8, and 24 hrs postdose on Day 32

ID	Title	Description
OG000	MEDI0382	Participants received SC dose of MEDI0382 titrated from 50 μg upto 300 μg (50 μg once daily for 4 days, followed by 100 μg daily for 7 days, 200 μg daily for 7 days, and 300 μg daily for 14 days) for 32 days.

Units	Counts
Participants	OG000

Secondary

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.

The PK population included all participants who received at least 1 dose of study drug and had at least one PK sample collected with a value above the lower limit of quantitation.

Posted

Median

Full Range

Hours

Predose and at 0.5, 1, 2, 4, 6, 8, and 24 hrs postdose on Day 32

ID	Title	Description
OG000	MEDI0382	Participants received SC dose of MEDI0382 titrated from 50 μg upto 300 μg (50 μg once daily for 4 days, followed by 100 μg daily for 7 days, 200 μg daily for 7 days, and 300 μg daily for 14 days) for 32 days.

Units	Counts
Participants	OG000

Secondary

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.

The PK population included all participants who received at least 1 dose of study drug and had at least one PK sample collected with a value above the lower limit of quantitation. Here, "n" signifies only the participants with available data were analyzed for the specified time points.

Posted

Geometric Mean

Full Range

ng/mL

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)

ID	Title	Description
OG000	MEDI0382	Participants received SC dose of MEDI0382 titrated from 50 μg upto 300 μg (50 μg once daily for 4 days, followed by 100 μg daily for 7 days, 200 μg daily for 7 days, and 300 μg daily for 14 days) for 32 days.

Units	Counts
Participants	OG000

Secondary

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.

As-treated population included all participants who received any dose of study drug and analyzed according to the treatment they actually received.

Posted

Count of Participants

Participants

Pre-dose on Days 1, 12, and 32 and on Day 60

ID	Title	Description
OG000	Placebo	Participants received subcutaneous dose (SC) of placebo matched to MEDI0382 once daily for 32 days.
OG001	MEDI0382	Participants received SC dose of MEDI0382 titrated from 50 μg upto 300 μg (50 μg once daily for 4 days, followed by 100 μg daily for 7 days, 200 μg daily for 7 days, and 300 μg daily for 14 days) for 32 days.

Units	Counts
Participants	OG000

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Bradyarrhythmia	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected21 at risk
Bundle branch block left	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected21 at risk
Bundle branch block right	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected21 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected21 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected21 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected21 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected21 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected21 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0015 events5 affected21 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected20 at risk EG0016 events5 affected21 at risk
Eructation	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected21 at risk
Flatulence	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0012 events2 affected21 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected21 at risk
Nausea	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected20 at risk EG00119 events9 affected21 at risk
Vomiting	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected20 at risk EG00118 events6 affected21 at risk
Complication associated with device	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected21 at risk
Injection site erythema	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected21 at risk
Injection site pruritus	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected21 at risk
Influenza	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected21 at risk
Nasopharyngitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected20 at risk EG0013 events3 affected21 at risk
Otitis media	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected21 at risk
Pyelonephritis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected21 at risk
Rhinitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected20 at risk EG0011 events1 affected21 at risk
Urinary tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected21 at risk
Face injury	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected21 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected21 at risk
Alanine aminotransferase increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected21 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected21 at risk
Glomerular filtration rate decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected21 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0013 events3 affected21 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected20 at risk EG0018 events3 affected21 at risk
Hypoglycaemia unawareness	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected21 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected21 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected21 at risk
Dizziness	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected20 at risk EG0012 events2 affected21 at risk
Headache	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0003 events2 affected20 at risk EG0013 events2 affected21 at risk
Nervousness	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected21 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected21 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected21 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected21 at risk
Skin fissures	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected21 at risk
Skin swelling	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected21 at risk

ID	Term
D003924	Diabetes Mellitus, Type 2
D051437	Renal Insufficiency

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Participants received subcutaneous dose (SC) of placebo matched to MEDI0382 once daily for 32 days.	0	20	2	20	13	20
EG001	MEDI0382	Participants received SC dose of MEDI0382 titrated from 50 μg upto 300 μg (50 μg once daily for 4 days, followed by 100 μg daily for 7 days, 200 μg daily for 7 days, and 300 μg daily for 14 days) for 32 days.	1	21	2	21	19	21

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected21 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected21 at risk
Hypertensive crisis	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected21 at risk
Syncope	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected20 at risk EG0010 events0 affected21 at risk