Adults 18 to 74, any sex, with Type 2 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) Through the End of the Up-titration PeriodPrimary· Baseline (Day -1) through Day 56 (end of Up-titration period)
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
TEAEs
Group
Value
95% CI
Placebo Cohort 1
2
MEDI0382 Cohort 1
6
Placebo Cohort 2
3
MEDI0382 Cohort 2
8
TESAEs
Group
Value
95% CI
Placebo Cohort 1
0
MEDI0382 Cohort 1
0
Placebo Cohort 2
0
MEDI0382 Cohort 2
0
Number of Participants With TEAEs and TESAEs Through the End of the Follow-up PeriodPrimary· Baseline (Day-1) through 28 days post last dose (end of follow-up period; approximately up to 5 months)
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A 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 stu
TEAEs
Group
Value
95% CI
Placebo Cohort 1
2
MEDI0382 Cohort 1
6
Placebo Cohort 2
3
MEDI0382 Cohort 2
8
TESAEs
Group
Value
95% CI
Placebo Cohort 1
0
MEDI0382 Cohort 1
0
Placebo Cohort 2
0
MEDI0382 Cohort 2
0
Number of Participants With Abnormal Electrocardiograms (ECGs) Reported as TEAEs Through the End of the Up-titration PeriodPrimary· Baseline (Day -1) through Day 56 (end of Up-titration period)
Number of participants with abnormal ECGs reported as TEAEs are reported. Abnormal ECGs is defined as any abnormal findings in heart rate, RR interval, PR interval, QRS, QT intervals, and QTcF intervals from the primary lead of the digital 12-lead ECG.
Atrial fibrillation
Group
Value
95% CI
Placebo Cohort 1
0
MEDI0382 Cohort 1
0
Placebo Cohort 2
0
MEDI0382 Cohort 2
1
Supraventricular extrasystoles
Group
Value
95% CI
Placebo Cohort 1
0
MEDI0382 Cohort 1
0
Placebo Cohort 2
0
MEDI0382 Cohort 2
1
Ventricular extrasystoles
Group
Value
95% CI
Placebo Cohort 1
0
MEDI0382 Cohort 1
0
Placebo Cohort 2
0
MEDI0382 Cohort 2
1
Ventricular tachycardia
Group
Value
95% CI
Placebo Cohort 1
1
MEDI0382 Cohort 1
0
Placebo Cohort 2
0
MEDI0382 Cohort 2
0
Number of Participants With Abnormal ECGs Reported as TEAEs Through the End of the Follow-up PeriodPrimary· Baseline (Day-1) through 28 days post last dose (end of follow-up period; approximately up to 5 months)
Number of participants with abnormal ECGs reported as TEAEs are reported. Abnormal ECGs is defined as any abnormal findings in heart rate, RR interval, PR interval, QRS, QT intervals, and QTcF intervals from the primary lead of the digital 12-lead ECG.
Atrial fibrillation
Group
Value
95% CI
Placebo Cohort 1
0
MEDI0382 Cohort 1
0
Placebo Cohort 2
0
MEDI0382 Cohort 2
1
Supraventricular extrasystoles
Group
Value
95% CI
Placebo Cohort 1
0
MEDI0382 Cohort 1
0
Placebo Cohort 2
0
MEDI0382 Cohort 2
1
Ventricular extrasystoles
Group
Value
95% CI
Placebo Cohort 1
0
MEDI0382 Cohort 1
0
Placebo Cohort 2
0
MEDI0382 Cohort 2
1
Ventricular tachycardia
Group
Value
95% CI
Placebo Cohort 1
1
MEDI0382 Cohort 1
0
Placebo Cohort 2
0
MEDI0382 Cohort 2
0
Number of Participants With Abnormal Vital Signs Reported as TEAEs Through the End of the Up-titration PeriodPrimary· Baseline (Day -1) through Day 56 (end of Up-titration period)
Number of participants with abnormal vital signs reported as TEAEs are reported. Abnormal vital signs are defined as any abnormal finding in the vital sign parameters (blood pressure, heart rate, body temperature, and respiratory rate).
Group
Value
95% CI
Placebo Cohort 1
0
MEDI0382 Cohort 1
1
Placebo Cohort 2
0
MEDI0382 Cohort 2
0
Number of Participants With Abnormal Vital Signs Reported as TEAEs Through the End of the Follow-up PeriodPrimary· Baseline (Day-1) through 28 days post last dose (end of follow-up period; approximately up to 5 months)
Number of participants with abnormal vital signs reported as TEAEs are reported. Abnormal vital signs are defined as any abnormal finding in the vital sign parameters (blood pressure, heart rate, body temperature, and respiratory rate).
Group
Value
95% CI
Placebo Cohort 1
0
MEDI0382 Cohort 1
1
Placebo Cohort 2
0
MEDI0382 Cohort 2
0
Number of Participants With Abnormal Physical Examinations Reported as TEAEs Through the End of the Up-titration PeriodPrimary· Baseline (Day -1) through Day 56 (end of Up-titration period)
Number of participants with abnormal physical examinations reported as TEAEs are reported. Abnormal physical examinations findings are defined as any abnormal finding in the following body systems: immunologic/allergy; head, ears, eyes, nose, and throat; respiratory; cardiovascular; gastrointestinal; musculoskeletal; neurological psychiatric; dermatologic; hematologic/lymphatic; and, endocrine.
Group
Value
95% CI
Placebo Cohort 1
0
MEDI0382 Cohort 1
3
Placebo Cohort 2
0
MEDI0382 Cohort 2
4
Number of Participants With Abnormal Physical Examinations Reported as TEAEs Through the End of the Follow-up PeriodPrimary· Baseline (Day-1) through 28 days post last dose (end of follow-up period; approximately up to 5 months)
Number of participants with abnormal physical examinations reported as TEAEs are reported. Abnormal physical examination findings are defined as any abnormal finding in the following body systems: immunologic/allergy; head, ears, eyes, nose, and throat; respiratory; cardiovascular; gastrointestinal; musculoskeletal; neurological psychiatric; dermatologic; hematologic/lymphatic; and endocrine.
Group
Value
95% CI
Placebo Cohort 1
0
MEDI0382 Cohort 1
3
Placebo Cohort 2
0
MEDI0382 Cohort 2
4
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs Through the End of the Up-titration PeriodPrimary· Baseline (Day -1) through Day 56 (end of Up-titration period)
Number of participants with abnormal clinical laboratory parameters reported as TEAEs are reported. Abnormal clinical laboratory parameters defined as any abnormal finding during analysis of serum chemistry, hematology, and urine.
Group
Value
95% CI
Placebo Cohort 1
0
MEDI0382 Cohort 1
1
Placebo Cohort 2
0
MEDI0382 Cohort 2
0
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs Through the End of the Follow-up PeriodPrimary· Baseline (Day-1) through 28 days post last dose (end of follow-up period; approximately up to 5 months)
Number of participants with abnormal clinical laboratory parameters reported as TEAEs are reported. Abnormal clinical laboratory parameters defined as any abnormal finding during analysis of serum chemistry, hematology, and urine.
Group
Value
95% CI
Placebo Cohort 1
0
MEDI0382 Cohort 1
1
Placebo Cohort 2
0
MEDI0382 Cohort 2
0
Area Under the Plasma Concentration Time Curve Over a Dosing Interval (AUCτ) of MEDI0382Secondary· Pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post dose on Days 1, 7, 14, 35, 42, 49 and 56; pre-dose on Days 22, 29, 70, 84; additional 48 and 72 hours post-dose on Day 84
Area under the plasma concentration time curve over a dosing duration (AUCτ) of MEDI0382 is reported.
Day 1
Group
Value
95% CI
MEDI0382 (Cohort 1 + Cohort 2)
20.9
15.9 – 29.0
Day 7
Group
Value
95% CI
MEDI0382 (Cohort 1 + Cohort 2)
23.7
17.2 – 41.3
Day 14
Group
Value
95% CI
MEDI0382 (Cohort 1 + Cohort 2)
59.9
35.8 – 101
Day 35
Group
Value
95% CI
MEDI0382 (Cohort 1 + Cohort 2)
276
183 – 694
Day 42
Group
Value
95% CI
MEDI0382 (Cohort 1 + Cohort 2)
332
247 – 735
Day 49
Group
Value
95% CI
MEDI0382 (Cohort 1 + Cohort 2)
434
308 – 752
Day 56
Group
Value
95% CI
MEDI0382 (Cohort 1 + Cohort 2)
611
343 – 2840
Day 84
Group
Value
95% CI
MEDI0382 (Cohort 1 + Cohort 2)
661
372 – 4740
Maximum Observed Serum Concentration (Cmax) of MEDI0382Secondary· Pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post dose on Days 1, 7, 14, 35, 42, 49 and 56; pre-dose on Days 22, 29, 70, 84; additional 48 and 72 hours post-dose on Day 84
Maximum observed serum concentration (Cmax) of MEDI0382 is reported.
Day 1
Group
Value
95% CI
MEDI0382 (Cohort 1 + Cohort 2)
1.02
0.447 – 1.84
Day 7
Group
Value
95% CI
MEDI0382 (Cohort 1 + Cohort 2)
1.35
0.934 – 2.51
Day 14
Group
Value
95% CI
MEDI0382 (Cohort 1 + Cohort 2)
3.43
2.02 – 6.37
Day 35
Group
Value
95% CI
MEDI0382 (Cohort 1 + Cohort 2)
15.3
9.74 – 36.1
Day 42
Group
Value
95% CI
MEDI0382 (Cohort 1 + Cohort 2)
17.8
12.7 – 37.8
Day 49
Group
Value
95% CI
MEDI0382 (Cohort 1 + Cohort 2)
24.9
15.2 – 39.0
Day 56
Group
Value
95% CI
MEDI0382 (Cohort 1 + Cohort 2)
32.8
17.7 – 137
Day 84
Group
Value
95% CI
MEDI0382 (Cohort 1 + Cohort 2)
35.3
19.7 – 202
Adverse events — posted to ClinicalTrials.gov
Time frame: Baseline (Day -1) through 28 days post last dose (approximately up to 5 months).
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is a Phase 2a, randomized, blinded, placebo-controlled study in up to 20 overweight or obese participants with type 2 diabetes mellitus. The participants will participate in the study for approximately 18 weeks, including screening, run-in and treatment periods and a safety follow-up.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
NCT03596177 — A Study to Evaluate the Effect of MEDI0382 on Energy Balance in Overweight and Obese Participants With Type 2 Diabetes M
· Phase 2
· completed
NCT03625778 — A Study to Assess Safety, Tolerability, and Pharmacokinetics of MEDI0382 in Non-diabetic Obese Participants
· Phase 1
· completed
NCT03550378 — A Study to Look at the Effect MEDI0382 Has on Blood Sugar in People With Type 2 Diabetes and Kidney Problems and Also to
· Phase 2
· completed
NCT03555994 — A Study to Investigate the Effect of MEDI0382 on Hepatic Glycogen Metabolism in Overweight and Obese Subjects With Type
· Phase 2
· completed
NCT03444584 — Study of MEDI0382 in Combination With Dapagliflozin and Metformin in Overweight/Obese Participants With Type 2 Diabetes
· Phase 2
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by MedImmune LLC
Last refreshed: 5 June 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03745937.