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CompletedPhase 2Results posted

A Study to Look at the Effect MEDI0382 Has on Blood Sugar in People With Type 2 Diabetes and Kidney Problems and Also to Check That MEDI0382 is Well Tolerated

A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of MEDI0382 in Subjects With Type 2 Diabetes Mellitus and Renal Impairment

Lead sponsor

MedImmune LLC

Asset

Cotadutide

Subcutaneous · GLP-1 / glucagon dual

Listed sites

7

Recruiting sites

Enrollment

41

actual

Study population

Renal impairment, Type 2 diabetes

Key I/E criteria

BMI 25-45HbA1c 6.5-10.5%eGFR 30-60

Primary endpoint

Postprandial glucose

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT03550378
Org study IDD5670C00013
Secondary ID2018-000019-26

Timeline

Milestones

Study first posted2018-06-08actual
Study start2018-06-29actual
Primary completion2019-02-04actual
Study completion2019-02-04actual
Last update posted2020-04-13actual
Results first posted2020-04-13actual

Assets

Investigational agents

Study populations

Who this study enrolls

Renal impairmentType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age84 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Age ≥ 18 and < 85 years at screening.

2. 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.

3. 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

4. Body mass index (BMI) between 25 and 45 kg/m^2 (inclusive) at screening

5. Haemoglobin A1c (HbA1c) range of 6.5 % to 10.5% (inclusive) at screening

6. 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.

7. 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

1. 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.

2. Concurrent participation in another interventional study of any kind and repeat randomisation in this study is prohibited.

3. 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.

4. 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)

5. Severe allergy/hypersensitivity to any of the proposed study treatments or excipients

6. Symptoms of acutely decompensated blood glucose control (eg, thirst, polyuria, weight loss), a history of type 1 diabetes mellitus or diabetic ketoacidosis

7. Participants who have undergone a renal transplant

8. 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)

9. 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

10. History of acute or chronic pancreatitis

11. 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

12. 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

13. 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

14. Severe congestive heart failure (New York Heart Association Class III or IV)

15. Basal calcitonin level > 50 ng/L at screening or history/family history of medullary thyroid carcinoma or multiple endocrine neoplasia

16. 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

17. Any positive results for serum hepatitis B surface antigen (HBsAg), hepatitis C antibody, and human immunodeficiency virus (HIV) antibody

18. Nephrotic range proteinuria defined as spot urine albumin creatinine ratio (ACR) > 250 mg/mmol at screening

19. 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

Endpoints (19)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK
10
Glycemic / diabetes
4
Cardiometabolic biomarkers
3
Weight & body composition
2

Weight & body composition

2 endpoints
Secondary/protocol endpoint

Percent Change Frome Baseline in Body Weight to Day 33

Time frame:Day 1 (Baseline) and Day 33

Body weight, % change

percent change from baseline, improvement

Posted result

GroupValue (least_squares_mean), Percent change in body weight95% CI
Placebo-0.21-1.05 – 0.62
MEDI0382-3.69-4.55 – -2.83
Secondary/protocol endpoint

Change From Baseline in Absolute Body Weight to Day 33

Time frame:Day 1 (Baseline) and Day 33

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

GroupValue (mean), Kg95% CI
Placebo-0.15
MEDI0382-3.39

Glycemic / diabetes

4 endpoints
Primary/protocol endpoint

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

Time frame: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

Postprandial glucose

percent change from baseline, improvement

Posted result

GroupValue (least_squares_mean), Percent change in plasma glucose95% CI
Placebo3.678-3.793 – 11.149
MEDI0382-26.706-34.584 – -18.828
LS Mean Difference-30.38490% CI-41.270-19.498p<0.001ANCOVA
Secondary/protocol endpoint

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

Time frame:Day 1 (Baseline) and Day 32

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

GroupValue (least_squares_mean), Percent95% CI
Placebo0.01-0.15 – 0.17
MEDI0382-0.65-0.82 – -0.49
Secondary/protocol endpoint

Change From Baseline in Fasting Glucose to Day 32

Time frame:Day 1 (Baseline) and Day 32

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

GroupValue (least_squares_mean), mg/dL95% CI
Placebo0.60-12.89 – 14.08
MEDI0382-19.55-33.39 – -5.71
Secondary/protocol endpoint

Change From Baseline in Percentage of Time Spent Within a Target Glucose Range Over a 7-day Period to the Final Week of Treatment

Time frame: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)

CGM time-in-range

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), Percentage of time95% CI
PlaceboDays 5 - 11-10.49-20.77 – -0.20
Days 12 - 18-5.34-12.77 – 2.10
Days 19 - 25-16.05-25.02 – -7.08
Days 26 - 32-21.23-33.13 – -9.32
MEDI0382Days 5 - 1112.252.52 – 21.98
Days 12 - 1815.628.39 – 22.86
Days 19 - 2519.1810.21 – 28.15
Days 26 - 3214.792.54 – 27.04

Cardiometabolic biomarkers

3 endpoints
Secondary/protocol endpoint

Change From Baseline in Postural Blood Pressure

Time frame:Baseline (Day 1) through Day 32

change from baseline, improvement

Posted result

GroupValue (mean), mmHg95% CI
PlaceboSystolic Blood Pressure0.1
Diastolic Blood Pressure1.8
MEDI0382Systolic Blood Pressure8.9
Diastolic Blood Pressure0.8
Secondary/protocol endpoint

Change From Baseline in Mean 24-hrs Pulse Rate to the End of Each Dosing Level

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

Heart rate, change

change from baseline, improvement

Posted result

GroupValue (mean), Beats/min95% CI
PlaceboDay 5-0.73
Day 121.04
Day 191.32
Day 32-0.92
MEDI0382Day 56.40
Day 129.01
Day 1912.72
Day 3211.85
Secondary/protocol endpoint

Change From Baseline in Mean 24-hrs Systolic and Diastolic Blood Pressure to the End of Each Dosing Level

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

change from baseline, improvement

Posted result

GroupValue (mean), mmHg95% CI
PlaceboDay 5: Systolic Blood Pressure-3.11
Day 12: Systolic Blood Pressure-2.67
Day 19: Systolic Blood Pressure-3.56
Day 32: Systolic Blood Pressure2.21
Day 5: Diastolic Blood Pressure-0.07
Day 12: Diastolic Blood Pressure-0.55
Day 19: Diastolic Blood Pressure-0.44
Day 32: Diastolic Blood Pressure1.84
MEDI0382Day 5: Systolic Blood Pressure-1.69
Day 12: Systolic Blood Pressure-4.34
Day 19: Systolic Blood Pressure-4.72
Day 32: Systolic Blood Pressure-1.15
Day 5: Diastolic Blood Pressure1.15
Day 12: Diastolic Blood Pressure1.28
Day 19: Diastolic Blood Pressure0.76
Day 32: Diastolic Blood Pressure2.54

Safety / tolerability / PK

10 endpoints
Secondary/protocol endpoint

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)

Time frame:Day 1 through Day 60

descriptive

componentsTreatment-emergent AEs (any), Serious AEs (any)

Posted result

GroupValue (count_of_participants), Participants95% CI
PlaceboTEAEs13
TESAEs2
MEDI0382TEAEs20
TESAEs2
Secondary/protocol endpoint

Number of Participants With Abnormal Vital Signs Reported as TEAEs

Time frame:Day 1 through Day 60

Treatment-emergent AEs (any)

event count, event

Posted result

GroupValue (count_of_participants), Participants95% CI
Placebo0
MEDI03820
Secondary/protocol endpoint

Number of Participants With Abnormal Electrocardiograms (ECGs) Reported as TEAEs

Time frame:Day 1 through Day 60

Treatment-emergent AEs (any)

event count, event

Posted result

GroupValue (count_of_participants), Participants95% CI
PlaceboBradyarrhythmia1
Bundle branch block left1
Bundle branch block right0
MEDI0382Bradyarrhythmia0
Bundle branch block left0
Bundle branch block right1
Secondary/protocol endpoint

Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs

Time frame:Day 1 through Day 60

Treatment-emergent AEs (any)

event count, event

Posted result

GroupValue (count_of_participants), Participants95% CI
PlaceboHypoglycaemia1
Alanine aminotransferase increased1
Aspartate aminotransferase increased1
Glomerular filtration rate decreased0
MEDI0382Hypoglycaemia3
Alanine aminotransferase increased0
Aspartate aminotransferase increased0
Glomerular filtration rate decreased1
Secondary/protocol endpoint

Number of Participants With Treatment-emergent Adverse Events of Special Interest (TEAESIs)

Time frame:Day 1 through Day 60

Treatment-emergent AEs (any)

event count, event

Posted result

GroupValue (count_of_participants), Participants95% CI
Placebo0
MEDI03820
Secondary/protocol endpoint

Area Under the Plasma Concentration Time Curve Over a Dosing Duration (AUCτ) of MEDI0382 at 300 μg

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

AUC₀–∞

concentration, descriptive

Posted result

GroupValue (geometric_mean), ng.hr/mL95% CI
MEDI0382285.93124.08 – 669.17
Secondary/protocol endpoint

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

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

Cmax

concentration, descriptive

Posted result

GroupValue (geometric_mean), ng/mL95% CI
MEDI038216.935.17 – 35.4
Secondary/protocol endpoint

Time to Observed Maximum Serum Concentration (Tmax) of MEDI0382 at 300 μg

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

Tmax

concentration, descriptive

Posted result

GroupValue (median), Hours95% CI
MEDI03825.64 – 24
Secondary/protocol endpoint

Trough Plasma Concentration (Ctrough) of MEDI0382

Time frame: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)

Plasma concentration (steady state)

concentration, descriptive

Posted result

GroupValue (geometric_mean), ng/mL95% CI
MEDI0382Day 51.440.48 – 2.58
Day 122.030.63 – 3.75
Day 193.680.59 – 8.86
Day 325.861.3 – 19.4
Day 335.962.43 – 19.2
Secondary/protocol endpoint

Number of Participants With Positive Anti-drug Antibodies (ADA) Titre to MEDI0382

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

Immunogenicity (ADA)

descriptive

Posted result

GroupValue (count_of_participants), Participants95% CI
PlaceboPositive at baseline0
Positive post-baseline0
Positive at baseline and post-baseline0
Not detected at baseline; positive post-baseline0
Positive at baseline; not detected post-baseline0
MEDI0382Positive at baseline0
Positive post-baseline2
Positive at baseline and post-baseline0
Not detected at baseline; positive post-baseline2
Positive at baseline; not detected post-baseline0

Publications (2)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.