← Trials/Trial dossier/NCT03444584

CompletedPhase 2Results posted

Study of MEDI0382 in Combination With Dapagliflozin and Metformin in Overweight/Obese Participants With Type 2 Diabetes

An Exploratory Phase 2a Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy and Safety of MEDI0382 Versus Placebo in Overweight/Obese Subjects With Type 2 Diabetes Mellitus Treated With Dapagliflozin and Metformin

Lead sponsor

MedImmune LLC

Asset

Cotadutide

Subcutaneous · GLP-1 / glucagon dual

Listed sites

8

Recruiting sites

Enrollment

49

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

BMI 25-40HbA1c 7-10%

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 IDNCT03444584
Org study IDD5670C00007
Secondary ID2017-002817-78

Timeline

Milestones

Study first posted2018-02-23actual
Study start2018-05-08actual
Primary completion2018-12-06actual
Study completion2018-12-06actual
Last update posted2020-01-13actual
Results first posted2020-01-13actual

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age115 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Male and female participants aged >= 18 years at screening.

2. Provision of signed and dated informed consent form (ICF) prior to any study specific procedures.

3. Body mass index between 25 kg/m^2 and 40 kg/m^2 (inclusive) at screening.

4. Hemoglobin A1c range between 7.0% and 10.0% (inclusive) at the time of screening.

5. Diagnosed with T2DM and treated with of metformin monotherapy (MTD > 1

g)at least 8 weeks prior to screening or treated with stable, oral doses of dapagliflozin 10 mg and metformin (MTD > 1
g)for at least 3 months prior screening.

6. Participants prescribed oral dual therapy with sulphonylurea, glitinide, or dipeptidyl peptidase-4 inhibitor (in addition to metformin) may be eligible to enter the study following a washout period of these medications totaling at least 28 days before initial screening evaluations have been completed.

7. Participants treated with stable doses of metformin (MTD > 1

g)with canagliflozin (maximum dose of 300 mg/day), or metformin (MTD > 1
g)with empaglifozin (maximum dose of 25mg/day) for at least 3 months prior to screening may be eligible to enter the study after switching to dapagliflozin.

8. Female participants of childbearing potential must have a negative pregnancy test at screening and randomization and must not be lactating.

9. Females of childbearing potential who are sexually active with a nonsterilized male partner must use at least one highly effective method of contraception from screening and must agree to continue using such precautions through to the end of the study. It is strongly recommended for the male partner of a female participant to also use male condom plus spermicide throughout this period. Cessation of contraception after this point should be discussed with a responsible physician. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception.

Exclusion criteria

1. History of, or any existing condition that in the opinion of the investigator would interfere with evaluation of the investigational product, put the participant at risk, influence the participant's ability to participate, or affect the interpretation of the results of the study and/or any participant unable or unwilling to follow study procedures.

2. Any participant who has received another investigational product not included in the protocol as part of a clinical trial or a glucagon-like peptide-1 (GLP-1) analogue or sodium-glucose cotransporter-2 (SGLT2)-containing preparation (excluding dapagliflozin, canagliflozin, empagliflozin) within the last 30 days or 5 half-lives of the drug (whichever is longest) at the time of screening.

3. Any participant who has received any of the following medications prior to the start of the screening period (Visit 1) or prior to the study start period (Visit 4):

Concurrent use of any medicinal products, or herbal or over-the-counter (OTC) preparations licensed for control of body weight or appetite at the time of screening (Visit 1)
Concurrent or previous use of drugs approved for weight loss (eg, orlistat, bupropion-naltrexone, phentermine-topiramate, phentermine, lorcaserin) within the last 30 days or 5 half-lives of the drug (whichever is longest) at the time of screening (Visit 1)
Concurrent use of aspirin (acetylsalicylic acid) at a dose greater than 150 mg once daily and within the last 72 hours prior to the start of the study (Visit 4)
Concurrent use of paracetamol (acetaminophen) or paracetamol-containing preparations at a total daily dose of greater than 3000 mg and within the last 72 hours prior to the start of the study (Visit 4)
Concurrent use of ascorbic acid (vitamin C) supplements at a total daily dose greater than 1000 mg and within the last 72 hours prior to the start of the study (Visit 4)
Concurrent use of opiates, domperidone, metoclopramide, or other drugs known to alter gastric emptying and within the last 72 hours prior to the start of the study (Visit 4)

4. Concurrent participation in another study of any kind and repeat randomization in this study is prohibited.

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

6. Diagnosis of type 1 diabetes mellitus, maturity-onset diabetes of the young, or latent autoimmune diabetes of adulthood or presence of anti-glutamic acid decarboxylase, anti-islet cell, or anti-insulin antibodies.

7. Symptoms of acutely decompensate blood glucose control (eg, thirst, polyuria, weight loss) at screening or randomization, a history of diabetes ketoacidosis (DKA), or hyperosmolar nonketotic coma or treatment with daily subcutaneous insulin within 90 days prior to screening.

8. Fasting hyperglycemia (> 250 mg/dL/ > 13.9 mmol/L) prior to randomization.

9. C-peptide level < lower limit of normal (LLN).

10. History of acute or chronic pancreatitis or pancreatectomy.

11. Hypertriglyceridemia (> 400 mg/dL) at screening.

12. 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.

13. Significant hepatic disease (except for nonalcoholic steatohepatitis or nonalcoholic fatty liver disease without portal hypertension or cirrhosis) and/or participants with any of the following results at screening:

Aspartate transaminase (AST) >= 3 × upper limit of normal (ULN)
Alanine transaminase (ALT) >= 3 × ULN
Total bilirubin (TBL) >= 2 × ULN

14. Impaired renal function defined as estimated glomerular filtration rate (eGFR) <= 60 mL/minute/1.73m^2 at screening (eGFR according to Modification of Diet in Renal Disease [MDRD] using the isotope dilution mass spectrometry-traceable MDRD Study Equation (SI units).

15. Use of loop diuretics within 1 month prior to screening.

16. Poorly controlled hypertension as defined below:

Systolic blood pressure (BP) > 160 mm Hg
Diastolic BP or >= 100 mm Hg After 10 minutes of supine rest and confirmed by repeated measurement at screening (Visit 1 for all participants).

17. 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.

18. Severe congestive heart failure (New York Heart Association Class III and IV)

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

20. Hemoglobinopathy, hemolytic anemia, or chronic anemia (hemoglobin concentration < 11.5 g/dL [115 g/L] for males and < 10.5 g/dL [105 g/L] for females) at screening or any other condition known to interfere with interpretation of HbA1c measurement.

21. 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.

22. Any positive results for serum hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus antibody.

23. Recent viral infection or illness requiring the use of antibiotics in the month prior to screening (Visit 1) for participants on dual therapy or prior to run-in period (Visit 2) for participants on monotherapy.

24. History of recurrent (at least 2) urinary tract and/or genital tract infections (including mycotic infections such as thrush) within 6 months prior to screening.

25. Substance dependence likely to impact participant safety or compliance with study procedures.

26. Involvement of any AstraZeneca, MedImmune, contract research organization, or study site employees and their close relatives.

Endpoints (29)

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
18
Glycemic / diabetes
11

Glycemic / diabetes

11 endpoints
Primary/protocol endpoint

Change From Baseline to Day 28 in Plasma Glucose Area Under the Concentration Time-curve From Time 0 to 4 Hours (AUC0-4hrs) as Measured by Mixed-meal Tolerance Test (MMTT)

Time frame:Zero minutes before and 15, 30, 45, 60, 90, 120, 180, and 240 minutes after consumption of the standardised meal on Day -1 (Baseline) and Day 28

Postprandial glucose

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), hr·mg/dL95% CI
Placebo-11.28-51.05 – 28.50
MEDI0382-154.37-192.45 – -116.29
LS mean difference-143.0995% CI-198.20-87.98p<0.0001ANCOVA
Primary/protocol endpoint

Percent Change From Baseline to Day 28 in Plasma Glucose AUC0-4hrs as Measured by MMTT

Time frame:Zero minutes before and 15, 30, 45, 60, 90, 120, 180, and 240 minutes after consumption of the standardised meal on Day -1 (Baseline) and Day 28

Postprandial glucose

percent change from baseline, improvement

Posted result

GroupValue (least_squares_mean), Percent change in Glucose AUC0-4hrs95% CI
Placebo-0.13-5.96 – 5.69
MEDI0382-22.30-27.88 – -16.73
LS mean difference-22.1795% CI-30.24-14.10p<0.0001ANCOVA
Secondary/protocol endpoint

Change From Baseline in Plasma Glucose AUC24-hrs to the End of Each Dosing Level as Measured by Continuous Glucose Monitoring (CGM)

Time frame:Day -1 (Baseline) through Day 7 for MEDI0382 100 μg, Day 14 for MEDI0382 200 μg, and Day 28 for MEDI0382 300 μg

change from baseline, improvement

Posted result

GroupValue (mean), hr.mg/dL95% CI
PlaceboDay 7 (MEDI0382 100 μg)49.14
Day 14 (MEDI0382 200 μg)57.30
Day 28 (MEDI0382 300 μg)229.47
MEDI0382Day 7 (MEDI0382 100 μg)-832.66
Day 14 (MEDI0382 200 μg)-666.05
Day 28 (MEDI0382 300 μg)-726.85
Secondary/protocol endpoint

Change From Baseline in Mean 24-hrs Plasma Glucose to the End of Each Dosing Level as Measured by CGM

Time frame:Day -1 (Baseline) through Day 7 for MEDI0382 100 μg, Day 14 for MEDI0382 200 μg, and Day 28 for MEDI0382 300 μg

change from baseline, improvement

Posted result

GroupValue (mean), mg/dL95% CI
PlaceboDay 7 (MEDI0382 100 μg)2.59
Day 14 (MEDI0382 200 μg)2.83
Day 28 (MEDI0382 300 μg)9.70
MEDI0382Day 7 (MEDI0382 100 μg)-34.74
Day 14 (MEDI0382 200 μg)-28.34
Day 28 (MEDI0382 300 μg)-30.55
Secondary/protocol endpoint

Change From Baseline in Standard Deviation of 24-hrs Plasma Glucose Readings to the End of Each Dosing Level as Measured by CGM

Time frame:Day -1 (Baseline) through Day 7 for MEDI0382 100 μg, Day 14 for MEDI0382 200 μg, and Day 28 for MEDI0382 300 μg

change from baseline, improvement

Posted result

GroupValue (mean), mg/dL95% CI
PlaceboDay 7 (MEDI0382 100 μg)-3.01
Day 14 (MEDI0382 200 μg)1.38
Day 28 (MEDI0382 300 μg)-4.39
MEDI0382Day 7 (MEDI0382 100 μg)-7.21
Day 14 (MEDI0382 200 μg)-7.52
Day 28 (MEDI0382 300 μg)-9.76
Secondary/protocol endpoint

Change From Baseline in Coefficient of Variation of 24-hrs Plasma Glucose Readings to the End of Each Dosing Level as Measured by CGM

Time frame:Day -1 (Baseline) through Day 7 for MEDI0382 100 μg, Day 14 for MEDI0382 200 μg, and Day 28 for MEDI0382 300 μg

change from baseline, improvement

Posted result

GroupValue (mean), Percent of coefficient of variation95% CI
PlaceboDay 7 (MEDI0382 100 μg)-2.37
Day 14 (MEDI0382 200 μg)0.96
Day 28 (MEDI0382 300 μg)-4.26
MEDI0382Day 7 (MEDI0382 100 μg)-0.45
Day 14 (MEDI0382 200 μg)-2.06
Day 28 (MEDI0382 300 μg)-3.21
Secondary/protocol endpoint

Change From Baseline in Mean Amplitude of Glucose Excursions (MAGE) of 24-hrs Plasma Glucose Readings to the End of Each Dosing Level as Measured by CGM

Time frame:Day -1 (Baseline) through Day 7 for MEDI0382 100 μg, Day 14 for MEDI0382 200 μg, and Day 28 for MEDI0382 300 μg

change from baseline, improvement

Posted result

GroupValue (mean), mg/dL95% CI
PlaceboDay 7 (MEDI0382 100 μg)-13.46
Day 14 (MEDI0382 200 μg)18.05
Day 28 (MEDI0382 300 μg)-8.09
MEDI0382Day 7 (MEDI0382 100 μg)-25.74
Day 14 (MEDI0382 200 μg)-26.59
Day 28 (MEDI0382 300 μg)-27.92
Secondary/protocol endpoint

Change From Baseline in the Percentage of 24-hrs Glucose Readings That Falls Within the Euglycemic Range to the End of Each Dosing as Measured by CGM

Time frame:Day -1 (Baseline) through Day 7 for MEDI0382 100 μg, Day 14 for MEDI0382 200 μg, and Day 28 for MEDI0382 300 μg

CGM time-in-range

change from baseline, improvement

Posted result

GroupValue (mean), Percent of Euglycemic Range95% CI
PlaceboDay 7 (MEDI0382 100 μg)-5.61
Day 14 (MEDI0382 200 μg)-2.79
Day 28 (MEDI0382 300 μg)-4.17
MEDI0382Day 7 (MEDI0382 100 μg)7.12
Day 14 (MEDI0382 200 μg)5.31
Day 28 (MEDI0382 300 μg)6.54
Secondary/protocol endpoint

Change From Baseline in the Percentage of 24-hrs Glucose Readings That Falls Within the Hyperglycemic Range to the End of Each Dosing as Measured by CGM

Time frame:Day -1 (Baseline) through Day 7 for MEDI0382 100 μg, Day 14 for MEDI0382 200 μg, and Day 28 for MEDI0382 300 μg

CGM time-above-range

change from baseline, improvement

Posted result

GroupValue (mean), Percent of hyperglycemic range95% CI
PlaceboDay 7 (MEDI0382 100 μg)3.62
Day 14 (MEDI0382 200 μg)0.36
Day 28 (MEDI0382 300 μg)6.08
MEDI0382Day 7 (MEDI0382 100 μg)-13.99
Day 14 (MEDI0382 200 μg)-9.81
Day 28 (MEDI0382 300 μg)-9.72
Secondary/protocol endpoint

Change From Baseline in the Percentage of 24-hrs Glucose Readings That Falls Within the Hypoglycemic Range to the End of Each Dosing as Measured by CGM

Time frame:Day -1 (Baseline) through Day 7 for MEDI0382 100 μg, Day 14 for MEDI0382 200 μg, and Day 28 for MEDI0382 300 μg

CGM time-below-range

percent change from baseline, improvement

Posted result

GroupValue (mean), Percent of hypoglycemic range95% CI
PlaceboDay 7 (MEDI0382 100 μg)1.17
Day 14 (MEDI0382 200 μg)2.00
Day 28 (MEDI0382 300 μg)-2.08
MEDI0382Day 7 (MEDI0382 100 μg)6.08
Day 14 (MEDI0382 200 μg)3.44
Day 28 (MEDI0382 300 μg)2.84
Secondary/protocol endpoint

Change From Baseline in the Percentage of 24-hrs Glucose Readings That Falls Within Clinically Significant Hypoglycemic Range to the End of Each Dosing as Measured by CGM

Time frame:Day -1 (Baseline) through Day 7 for MEDI0382 100 μg, Day 14 for MEDI0382 200 μg, and Day 28 for MEDI0382 300 μg

CGM time-below-range

change from baseline, improvement

Posted result

GroupValue (mean), Percent of hypoglycemic range95% CI
PlaceboDay 7 (MEDI0382 100 μg)0.76
Day 14 (MEDI0382 200 μg)0.27
Day 28 (MEDI0382 300 μg)-0.26
MEDI0382Day 7 (MEDI0382 100 μg)1.61
Day 14 (MEDI0382 200 μg)-0.06
Day 28 (MEDI0382 300 μg)0.93

Safety / tolerability / PK

18 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 28 days after the last dose of MEDI0382 (approximately 8 weeks)

Treatment-emergent AEs (any)

event count, event

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

Posted result

GroupValue (count_of_participants), Participants95% CI
PlaceboTEAEs14
TESAEs0
MEDI0382TEAEs13
TESAEs0
Secondary/protocol endpoint

Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Reported as TEAEs

Time frame:Day 1 through 28 days after the last dose of MEDI0382 (approximately 8 weeks)

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 Vital Signs Reported as TEAEs

Time frame:Day 1 through 28 days after the last dose of MEDI0382 (approximately 8 weeks)

Treatment-emergent AEs (any)

event count, event

Posted result

GroupValue (count_of_participants), Participants95% CI
PlaceboTachycardia2
Tachycardia paroxysmal1
Palpitations0
MEDI0382Tachycardia1
Tachycardia paroxysmal0
Palpitations1
Secondary/protocol endpoint

Number of Participants With Abnormal Physical Examinations Reported as TEAEs

Time frame:Day 1 through 28 days after the last dose of MEDI0382 (approximately 8 weeks)

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 Clinical Laboratory Parameters Reported as TEAEs

Time frame:Day 1 through 28 days after the last dose of MEDI0382 (approximately 8 weeks)

Treatment-emergent AEs (any)

event count, event

Posted result

GroupValue (count_of_participants), Participants95% CI
Placebo1
MEDI03820
Secondary/protocol endpoint

Area Under the Plasma Concentration Time Curve From Time Zero to Infinity (AUC [0-∞]) of MEDI0382

Time frame:Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hrs post-dose on Days 7, 14, and 28

AUC₀–∞

concentration, descriptive

Posted result

GroupValue (geometric_mean), ng.hr/mL95% CI
MEDI0382Day 7 (MEDI0382 100 µg)106.457.7 – 251.8
Day 14 ( MEDI0382 200 µg)196.799.4 – 472.0
Day 28 (MEDI0382 300 µg)314.6211.0 – 537.3
Secondary/protocol endpoint

Area Under the Plasma Concentration Time Curve From Time Zero to Infinity (AUC [0-∞]) of Dapagliflozin

Time frame:Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hrs post-dose on Days -1, 7, 14, and 28

AUC₀–∞

concentration, descriptive

Posted result

GroupValue (geometric_mean), ng.hr/mL95% CI
PlaceboDay -1432.6271.5 – 918.6
Day 7410.2209.9 – 1024.2
Day 14421.0219.0 – 1327.8
Day 28405.7261.1 – 799.5
MEDI0382Day -1473.8288.8 – 1073.2
Day 7438.0222.2 – 833.6
Day 14448.6247.0 – 615.9
Day 28523.4319.5 – 946.0
Secondary/protocol endpoint

Area Under the Plasma Concentration-time Curve During the Dosing Period (AUCtau) of MEDI0382

Time frame:Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hrs post-dose on Days 7, 14, and 28

AUC₀–∞

concentration, descriptive

Posted result

GroupValue (geometric_mean), ng.hr/mL95% CI
MEDI0382Day 7 (MEDI0382 100 µg)89.643.1 – 199.4
Day 14 ( MEDI0382 200 µg)165.086.9 – 365.5
Day 28 (MEDI0382 300 µg)265.9101.7 – 795.1
Secondary/protocol endpoint

Area Under the Plasma Concentration-time Curve During the Dosing Period (AUCtau) of Dapagliflozin

Time frame:Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hrs post-dose on Days -1, 7, 14, and 28

AUC₀–∞

concentration, descriptive

Posted result

GroupValue (geometric_mean), ng.hr/mL95% CI
PlaceboDay -1400.9182.4 – 1011.5
Day 7377.576.4 – 910.7
Day 14417.1209.0 – 1107.7
Day 28423.1180.6 – 977.3
MEDI0382Day -1430.3252.5 – 815.2
Day 7406.8211.5 – 1142.6
Day 14396.8215.4 – 669.7
Day 28463.8284.3 – 1245.7
Secondary/protocol endpoint

Maximum Observed Serum Concentration (Cmax) of MEDI0382

Time frame:Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hrs post-dose on Days 7, 14, and 28

Cmax

concentration, descriptive

Posted result

GroupValue (geometric_mean), ng/mL95% CI
MEDI0382Day 7 (MEDI0382 100 µg)5.22.7 – 11.9
Day 14 ( MEDI0382 200 µg)10.14.4 – 21.7
Day 28 (MEDI0382 300 µg)17.26.1 – 45.4
Secondary/protocol endpoint

Maximum Observed Serum Concentration (Cmax) of Dapagliflozin

Time frame:Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hrs post-dose on Days -1, 7, 14, and 28

Cmax

concentration, descriptive

Posted result

GroupValue (geometric_mean), ng/mL95% CI
PlaceboDay -1110.146.3 – 208.3
Day 792.05.2 – 256.7
Day 1495.633.5 – 280.7
Day 28112.247.0 – 235.4
MEDI0382Day -1116.738.2 – 206.8
Day 784.424.1 – 211.7
Day 1461.115.8 – 149.9
Day 2894.225.2 – 182.2
Secondary/protocol endpoint

Time to Reach Maximum Observed Serum Concentration (Tmax) of MEDI0382

Time frame:Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hrs post-dose on Days 7, 14, and 28

Tmax

descriptive

Posted result

GroupValue (median), Hours95% CI
MEDI0382Day 7 (MEDI0382 100 µg)5.52 – 8
Day 14 ( MEDI0382 200 µg)5.12 – 8
Day 28 (MEDI0382 300 µg)41.9 – 8.1
Secondary/protocol endpoint

Time to Reach Maximum Observed Serum Concentration (Tmax) of Dapagliflozin

Time frame:Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hrs post-dose on Days -1, 7, 14, and 28

Tmax

descriptive

Posted result

GroupValue (median), Hours95% CI
PlaceboDay -110.5 – 2
Day 710.5 – 11.4
Day 141.10.5 – 6
Day 2810.2 – 1.8
MEDI0382Day -110.4 – 23.9
Day 710.5 – 4
Day 1410 – 8.1
Day 2810.5 – 8.1
Secondary/protocol endpoint

Terminal Elimination Half-life (t½) of MEDI0382

Time frame:Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hrs post-dose on Days 7, 14, and 28

Half-life

descriptive

Posted result

GroupValue (geometric_mean), Hours95% CI
MEDI0382Day 7 (MEDI0382 100 µg)8.86.1 – 11.9
Day 14 ( MEDI0382 200 µg)95.6 – 11.8
Day 28 (MEDI0382 300 µg)9.15.1 – 11.6
Secondary/protocol endpoint

Terminal Elimination Half-life (t½) of Dapagliflozin

Time frame:Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hrs post-dose on Days -1, 7, 14, and 28

Half-life

descriptive

Posted result

GroupValue (geometric_mean), Hours95% CI
PlaceboDay -18.25.3 – 11.2
Day 77.94.1 – 10.4
Day 147.05.1 – 11.4
Day 287.65.8 – 11.0
MEDI0382Day -17.85.4 – 11.3
Day 78.35.8 – 11.1
Day 148.57 – 10
Day 289.16.1 – 11.8
Secondary/protocol endpoint

Apparent Clearance (CL/F) of MEDI0382

Time frame:Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hrs post-dose on Days 7, 14, and 28

descriptive

Posted result

GroupValue (geometric_mean), L/hr95% CI
MEDI0382Day 7 (MEDI0382 100 µg)1.10.5 – 1.9
Day 14 ( MEDI0382 200 µg)1.30.5 – 2.2
Day 28 (MEDI0382 300 µg)1.20.8 – 1.8
Secondary/protocol endpoint

Apparent Clearance (CL/F) of Dapagliflozin

Time frame:Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hrs post-dose on Days -1, 7, 14, and 28

descriptive

Posted result

GroupValue (geometric_mean), L/Hr95% CI
PlaceboDay -125.513.3 – 38.9
Day 726.711.0 – 52.8
Day 1425.99.0 – 47.7
Day 2826.813.8 – 40.2
MEDI0382Day -123.312.3 – 39.6
Day 725.714.2 – 47.3
Day 1425.518.8 – 46.4
Day 2822.213.4 – 35.2
Secondary/protocol endpoint

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

Time frame:Day 1 (pre-dose), on Day 29 , and 28 days post last dose (end of study visit; approximately 8 weeks)

Immunogenicity (ADA)

threshold achievement, event

Posted result

GroupValue (count_of_participants), Participants95% CI
PlaceboDay 10
Day 290
End of Study1
MEDI0382Day 13
Day 291
End of Study2

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.