← Trials/Trial dossier/NCT03444584
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
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 25-40•HbA1c 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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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
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
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):
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:
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:
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
Glycemic / diabetes
11 endpointsChange 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
| Group | Value (least_squares_mean), hr·mg/dL | 95% CI |
|---|---|---|
| Placebo | -11.28 | -51.05 – 28.50 |
| MEDI0382 | -154.37 | -192.45 – -116.29 |
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
| Group | Value (least_squares_mean), Percent change in Glucose AUC0-4hrs | 95% CI |
|---|---|---|
| Placebo | -0.13 | -5.96 – 5.69 |
| MEDI0382 | -22.30 | -27.88 – -16.73 |
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
| Group | Value (mean), hr.mg/dL | 95% 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 | — |
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
| Group | Value (mean), mg/dL | 95% 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 | — |
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
| Group | Value (mean), mg/dL | 95% 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 | — |
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
| Group | Value (mean), Percent of coefficient of variation | 95% 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 | — |
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
| Group | Value (mean), mg/dL | 95% 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 | — |
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
| Group | Value (mean), Percent of Euglycemic Range | 95% 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 | — |
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
| Group | Value (mean), Percent of hyperglycemic range | 95% 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 | — |
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
| Group | Value (mean), Percent of hypoglycemic range | 95% 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 | — |
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
| Group | Value (mean), Percent of hypoglycemic range | 95% 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 endpointsNumber 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
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| PlaceboTEAEs | 14 | — |
| TESAEs | 0 | — |
| MEDI0382TEAEs | 13 | — |
| TESAEs | 0 | — |
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
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Placebo | 0 | — |
| MEDI0382 | 0 | — |
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
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| PlaceboTachycardia | 2 | — |
| Tachycardia paroxysmal | 1 | — |
| Palpitations | 0 | — |
| MEDI0382Tachycardia | 1 | — |
| Tachycardia paroxysmal | 0 | — |
| Palpitations | 1 | — |
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
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Placebo | 0 | — |
| MEDI0382 | 0 | — |
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
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Placebo | 1 | — |
| MEDI0382 | 0 | — |
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
| Group | Value (geometric_mean), ng.hr/mL | 95% CI |
|---|---|---|
| MEDI0382Day 7 (MEDI0382 100 µg) | 106.4 | 57.7 – 251.8 |
| Day 14 ( MEDI0382 200 µg) | 196.7 | 99.4 – 472.0 |
| Day 28 (MEDI0382 300 µg) | 314.6 | 211.0 – 537.3 |
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
| Group | Value (geometric_mean), ng.hr/mL | 95% CI |
|---|---|---|
| PlaceboDay -1 | 432.6 | 271.5 – 918.6 |
| Day 7 | 410.2 | 209.9 – 1024.2 |
| Day 14 | 421.0 | 219.0 – 1327.8 |
| Day 28 | 405.7 | 261.1 – 799.5 |
| MEDI0382Day -1 | 473.8 | 288.8 – 1073.2 |
| Day 7 | 438.0 | 222.2 – 833.6 |
| Day 14 | 448.6 | 247.0 – 615.9 |
| Day 28 | 523.4 | 319.5 – 946.0 |
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
| Group | Value (geometric_mean), ng.hr/mL | 95% CI |
|---|---|---|
| MEDI0382Day 7 (MEDI0382 100 µg) | 89.6 | 43.1 – 199.4 |
| Day 14 ( MEDI0382 200 µg) | 165.0 | 86.9 – 365.5 |
| Day 28 (MEDI0382 300 µg) | 265.9 | 101.7 – 795.1 |
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
| Group | Value (geometric_mean), ng.hr/mL | 95% CI |
|---|---|---|
| PlaceboDay -1 | 400.9 | 182.4 – 1011.5 |
| Day 7 | 377.5 | 76.4 – 910.7 |
| Day 14 | 417.1 | 209.0 – 1107.7 |
| Day 28 | 423.1 | 180.6 – 977.3 |
| MEDI0382Day -1 | 430.3 | 252.5 – 815.2 |
| Day 7 | 406.8 | 211.5 – 1142.6 |
| Day 14 | 396.8 | 215.4 – 669.7 |
| Day 28 | 463.8 | 284.3 – 1245.7 |
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
| Group | Value (geometric_mean), ng/mL | 95% CI |
|---|---|---|
| MEDI0382Day 7 (MEDI0382 100 µg) | 5.2 | 2.7 – 11.9 |
| Day 14 ( MEDI0382 200 µg) | 10.1 | 4.4 – 21.7 |
| Day 28 (MEDI0382 300 µg) | 17.2 | 6.1 – 45.4 |
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
| Group | Value (geometric_mean), ng/mL | 95% CI |
|---|---|---|
| PlaceboDay -1 | 110.1 | 46.3 – 208.3 |
| Day 7 | 92.0 | 5.2 – 256.7 |
| Day 14 | 95.6 | 33.5 – 280.7 |
| Day 28 | 112.2 | 47.0 – 235.4 |
| MEDI0382Day -1 | 116.7 | 38.2 – 206.8 |
| Day 7 | 84.4 | 24.1 – 211.7 |
| Day 14 | 61.1 | 15.8 – 149.9 |
| Day 28 | 94.2 | 25.2 – 182.2 |
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
| Group | Value (median), Hours | 95% CI |
|---|---|---|
| MEDI0382Day 7 (MEDI0382 100 µg) | 5.5 | 2 – 8 |
| Day 14 ( MEDI0382 200 µg) | 5.1 | 2 – 8 |
| Day 28 (MEDI0382 300 µg) | 4 | 1.9 – 8.1 |
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
| Group | Value (median), Hours | 95% CI |
|---|---|---|
| PlaceboDay -1 | 1 | 0.5 – 2 |
| Day 7 | 1 | 0.5 – 11.4 |
| Day 14 | 1.1 | 0.5 – 6 |
| Day 28 | 1 | 0.2 – 1.8 |
| MEDI0382Day -1 | 1 | 0.4 – 23.9 |
| Day 7 | 1 | 0.5 – 4 |
| Day 14 | 1 | 0 – 8.1 |
| Day 28 | 1 | 0.5 – 8.1 |
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
| Group | Value (geometric_mean), Hours | 95% CI |
|---|---|---|
| MEDI0382Day 7 (MEDI0382 100 µg) | 8.8 | 6.1 – 11.9 |
| Day 14 ( MEDI0382 200 µg) | 9 | 5.6 – 11.8 |
| Day 28 (MEDI0382 300 µg) | 9.1 | 5.1 – 11.6 |
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
| Group | Value (geometric_mean), Hours | 95% CI |
|---|---|---|
| PlaceboDay -1 | 8.2 | 5.3 – 11.2 |
| Day 7 | 7.9 | 4.1 – 10.4 |
| Day 14 | 7.0 | 5.1 – 11.4 |
| Day 28 | 7.6 | 5.8 – 11.0 |
| MEDI0382Day -1 | 7.8 | 5.4 – 11.3 |
| Day 7 | 8.3 | 5.8 – 11.1 |
| Day 14 | 8.5 | 7 – 10 |
| Day 28 | 9.1 | 6.1 – 11.8 |
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
| Group | Value (geometric_mean), L/hr | 95% CI |
|---|---|---|
| MEDI0382Day 7 (MEDI0382 100 µg) | 1.1 | 0.5 – 1.9 |
| Day 14 ( MEDI0382 200 µg) | 1.3 | 0.5 – 2.2 |
| Day 28 (MEDI0382 300 µg) | 1.2 | 0.8 – 1.8 |
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
| Group | Value (geometric_mean), L/Hr | 95% CI |
|---|---|---|
| PlaceboDay -1 | 25.5 | 13.3 – 38.9 |
| Day 7 | 26.7 | 11.0 – 52.8 |
| Day 14 | 25.9 | 9.0 – 47.7 |
| Day 28 | 26.8 | 13.8 – 40.2 |
| MEDI0382Day -1 | 23.3 | 12.3 – 39.6 |
| Day 7 | 25.7 | 14.2 – 47.3 |
| Day 14 | 25.5 | 18.8 – 46.4 |
| Day 28 | 22.2 | 13.4 – 35.2 |
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
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| PlaceboDay 1 | 0 | — |
| Day 29 | 0 | — |
| End of Study | 1 | — |
| MEDI0382Day 1 | 3 | — |
| Day 29 | 1 | — |
| End of Study | 2 | — |
Provenance
Sources
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.