Adults 20 to 120, any sex, with Type 2 Diabetes. 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.
Mean Change From Baseline in 24-Hour Heart Rate at Days 20 and 48Primary· Baseline (Day -1) and Days 20 and 48.
Twenty four-hour heart rate was determined using an ambulatory blood pressure monitoring (ABPM) device, and the mean change from baseline in the 24-hour heart rate is presented for Days 20 and 48.
Day 20
Group
Value
95% CI
Placebo
-1.86
± 7.43
MEDI0382 100 mcg
6.65
± 7.46
MEDI0382 200 mcg
13.50
± 5.86
MEDI0382 300 mcg
15.80
± 7.86
Day 48
Group
Value
95% CI
Placebo
-0.25
± 7.24
MEDI0382 100 mcg
7.87
± 8.60
MEDI0382 200 mcg
12.81
± 4.93
MEDI0382 300 mcg
15.22
± 5.50
Mean Change From Baseline in 24-Hour Systolic and Diastolic Blood Pressure (BP) at Days 20 and 48Primary· Baseline (Day -1) and Days 20 and 48.
Twenty four-hour BP was determined using an ABPM device, and the mean change from baseline in the 24-hour systolic BP and 24-hour diastolic BP are presented for Days 20 and 48.
24-hour Systolic BP: Day 20
Group
Value
95% CI
Placebo
2.98
± 9.00
MEDI0382 100 mcg
-4.09
± 8.93
MEDI0382 200 mcg
-7.24
± 10.54
MEDI0382 300 mcg
-2.48
± 9.28
24-hour Systolic BP: Day 48
Group
Value
95% CI
Placebo
0.08
± 14.32
MEDI0382 100 mcg
-2.27
± 12.42
MEDI0382 200 mcg
-5.17
± 19.35
MEDI0382 300 mcg
-6.97
± 7.48
24-hour Diastolic BP: Day 20
Group
Value
95% CI
Placebo
0.98
± 4.34
MEDI0382 100 mcg
-0.62
± 3.42
MEDI0382 200 mcg
-1.41
± 4.56
MEDI0382 300 mcg
0.81
± 5.58
24-hour Diastolic BP: Day 48
Group
Value
95% CI
Placebo
-0.06
± 6.82
MEDI0382 100 mcg
-0.66
± 4.56
MEDI0382 200 mcg
-0.27
± 9.17
MEDI0382 300 mcg
-0.68
± 3.88
Mean Percentage Change From Baseline in Glucose Area Under the Plasma Concentration Curve (AUC[0-4h]) as Measured by a Standardised Mixed-Meal Test (MMT) at Day 48Primary· Baseline (Day -1) and Day 48: 15 minutes before standardised meal, and then at 15, 30, 45, 60, 90, 120, 180 and 240 minutes (+/-5 minutes) after consumption of the standardised meal.
The MMT was conducted following a minimum 8-hour fast. Blood samples for glucose monitoring were taken 15 minutes before the patient consumed a standardised meal, and samples were taken at intervals after the meal, up to 4 hours. The MMT glucose AUC(0-4h) was calculated using a trapezoidal method, and the mean percentage change from baseline at Day 48 was analysed using an analysis of covariance (ANCOVA) model with treatment group as a factor and baseline as a covariate.
Group
Value
95% CI
Placebo
2.45
-3.37 – 8.26
MEDI0382 100 mcg
-39.66
-45.67 – -33.66
MEDI0382 200 mcg
-31.16
-38.61 – -23.71
MEDI0382 300 mcg
-37.86
-44.95 – -30.76
Mean Percentage Change From Baseline in Body Weight at Day 48Primary· Baseline (Day -1) and Day 48.
The mean percentage change from baseline in body weight at Day 48 was analysed using an ANCOVA model with treatment group as a factor and baseline as a covariate. For patients who prematurely discontinued IP, the last on-treatment measurement, regardless of rescue medication, was used (last observation carried forward \[LOCF\]).
Group
Value
95% CI
Placebo
-0.82
-2.06 – 0.43
MEDI0382 100 mcg
-2.12
-3.40 – -0.84
MEDI0382 200 mcg
-3.34
-4.68 – -2.01
MEDI0382 300 mcg
-3.34
-4.61 – -2.06
Mean Change From Baseline in Heart Rate Measured by Electrocardiogram (ECG) at Day 48.Primary· Baseline (Day -1) and Days 1, 6, 13, 20 and 48: predose and 6 hours (+/-15 minutes) postdose.
Digital ECGs were taken at baseline and predose and postdose on Days 1, 6, 13, 20 and 48. The mean change from baseline is presented.
Day 1: 6 hours postdose
Group
Value
95% CI
Placebo
1.77
± 7.20
MEDI0382 100 mcg
4.24
± 5.00
MEDI0382 200 mcg
2.18
± 8.62
MEDI0382 300 mcg
6.27
± 7.91
Day 6: predose
Group
Value
95% CI
Placebo
-2.85
± 4.93
MEDI0382 100 mcg
1.84
± 8.56
MEDI0382 200 mcg
7.69
± 7.11
MEDI0382 300 mcg
10.79
± 5.87
Day 6: 6 hours postdose
Group
Value
95% CI
Placebo
0.02
± 8.79
MEDI0382 100 mcg
4.62
± 9.11
MEDI0382 200 mcg
8.88
± 6.06
MEDI0382 300 mcg
10.67
± 7.59
Day 13: predose
Group
Value
95% CI
Placebo
-2.63
± 5.58
MEDI0382 100 mcg
6.91
± 8.83
MEDI0382 200 mcg
8.93
± 6.84
MEDI0382 300 mcg
11.74
± 7.92
Day 13: 6 hours postdose
Group
Value
95% CI
Placebo
2.19
± 9.13
MEDI0382 100 mcg
6.40
± 11.41
MEDI0382 200 mcg
16.62
± 7.14
MEDI0382 300 mcg
13.31
± 9.45
Day 20: predose
Group
Value
95% CI
Placebo
-1.85
± 7.52
MEDI0382 100 mcg
6.24
± 8.02
MEDI0382 200 mcg
11.97
± 8.12
MEDI0382 300 mcg
13.03
± 8.65
Day 20: 6 hours postdose
Group
Value
95% CI
Placebo
0.29
± 9.15
MEDI0382 100 mcg
5.09
± 9.37
MEDI0382 200 mcg
16.79
± 6.21
MEDI0382 300 mcg
16.94
± 8.86
Day 48: predose
Group
Value
95% CI
Placebo
-1.06
± 10.06
MEDI0382 100 mcg
7.20
± 5.88
MEDI0382 200 mcg
10.20
± 9.70
MEDI0382 300 mcg
17.06
± 6.12
Number of Patients Who Experienced Adverse Events (AEs)Primary· Day 1 up to 14 days after the last dose of IP (approximately 9 weeks).
AEs were collected from Day 1 of treatment up to 14 days after the last dose of IP. Serious AEs (SAEs) were collected from signing of informed consent. The numbers of patients who experienced any AE, any SAE (including events with an outcome of death), and any AE leading to discontinuation of IP are presented.
Any AE
Group
Value
95% CI
Placebo
6
MEDI0382 100 mcg
6
MEDI0382 200 mcg
11
MEDI0382 300 mcg
9
Any SAE
Group
Value
95% CI
Placebo
0
MEDI0382 100 mcg
0
MEDI0382 200 mcg
0
MEDI0382 300 mcg
0
Any AE leading to discontinuation of IP
Group
Value
95% CI
Placebo
0
MEDI0382 100 mcg
0
MEDI0382 200 mcg
4
MEDI0382 300 mcg
1
Mean Change From Baseline in HbA1c at Day 48Secondary· Baseline (Day -1) and Day 48 (predose).
The mean change from baseline in HbA1c at Day 48 was analysed using an ANCOVA model with treatment group as a factor and baseline as a covariate. For patients who prematurely discontinued IP, or for patients who did not have a measurement taken on Day 48, the last post-baseline measurement, regardless of rescue medication, was used (LOCF).
Group
Value
95% CI
Placebo
-0.14
-0.41 – 0.12
MEDI0382 100 mcg
-1.23
-1.51 – -0.96
MEDI0382 200 mcg
-1.24
-1.53 – -0.96
MEDI0382 300 mcg
-0.90
-1.18 – -0.63
Mean Change From Baseline in Fasting Plasma Glucose at Day 48Secondary· Baseline (Day -1) and Day 48 (predose).
The mean change from baseline in fasting plasma glucose at Day 48 was analysed using an ANCOVA model with treatment group as a factor and baseline as a covariate. For patients who prematurely discontinued IP, or for patients who did not have a measurement taken on Day 48, the last post-baseline measurement, regardless of rescue medication, was used (LOCF).
Group
Value
95% CI
Placebo
-0.40
-12.60 – 11.80
MEDI0382 100 mcg
-57.10
-69.77 – -44.42
MEDI0382 200 mcg
-60.98
-76.82 – -45.15
MEDI0382 300 mcg
-55.47
-70.28 – -40.66
Mean Change From Baseline in Fructosamine at Day 48Secondary· Baseline (Day -1) and Day 48 (predose).
The mean change from baseline in fructosamine at Day 48 was analysed using an ANCOVA model with treatment group as a factor and baseline as a covariate. For patients who prematurely discontinued IP, the last on-treatment measurement, regardless of rescue medication, was used (LOCF).
Group
Value
95% CI
Placebo
-0.012
-0.029 – 0.004
MEDI0382 100 mcg
-0.083
-0.100 – -0.066
MEDI0382 200 mcg
-0.066
-0.083 – -0.048
MEDI0382 300 mcg
-0.061
-0.079 – -0.044
Mean Change From Baseline in the Percentage of Time in Hyperglycaemia Over 24 Hours at Days 5, 12, 19 and 47Secondary· Baseline (Day -8 to -2) and Days 5, 12, 19 and 47.
Hyperglycaemia was defined as blood glucose \>7.8 mmol/L or \>140 mg/dL. Continuous glucose monitoring used a device fitted to the upper arm by trained study site staff to measure and record interstitial glucose levels every 15 minutes. Analysis was based on 24-hour readings defined as the first available time point with a valid continuous glucose monitoring glucose reading. The change in the percentage time in hyperglycaemia from the last day of baseline continuous glucose monitoring over 24 hours to the end of dosing at each dose level for the indicated timepoints is presented.
Day 5
Group
Value
95% CI
Placebo
-3.23
± 12.59
MEDI0382 100 mcg
-48.35
± 21.27
MEDI0382 200 mcg
-33.71
± 24.67
MEDI0382 300 mcg
-51.33
± 30.04
Day 12
Group
Value
95% CI
Placebo
-11.72
± 28.58
MEDI0382 100 mcg
-57.74
± 24.59
MEDI0382 200 mcg
-53.36
± 21.59
MEDI0382 300 mcg
-55.78
± 25.19
Day 19
Group
Value
95% CI
Placebo
-12.08
± 17.61
MEDI0382 100 mcg
-59.57
± 16.98
MEDI0382 200 mcg
-43.85
± 28.96
MEDI0382 300 mcg
-60.68
± 24.93
Day 47
Group
Value
95% CI
Placebo
-6.15
± 22.80
MEDI0382 100 mcg
-47.99
± 20.63
MEDI0382 200 mcg
-48.96
± 20.28
MEDI0382 300 mcg
-57.59
± 21.86
Mean Change From Baseline in the Percentage of Time in Hypoglycaemia Over 24 Hours at Days 5, 12, 19 and 47Secondary· Baseline (Day -8 to -2) and Days 5, 12, 19 and 47.
Hypoglycaemia was defined as blood glucose \<3 mmol/L or \<54 mg/dL. Continuous glucose monitoring used a device fitted to the upper arm by trained study site staff to measure and record interstitial glucose levels every 15 minutes. Analysis was based on 24-hour readings defined as the first available time point with a valid continuous glucose monitoring glucose reading. The change in the percentage time in hypoglycaemia from the last day of baseline continuous glucose monitoring over 24 hours to the end of dosing at each dose level for the timepoints is presented.
Day 5
Group
Value
95% CI
Placebo
0.00
± 0.00
MEDI0382 100 mcg
0.00
± 0.00
MEDI0382 200 mcg
0.00
± 0.00
MEDI0382 300 mcg
6.28
± 16.61
Day 12
Group
Value
95% CI
Placebo
0.00
± 0.00
MEDI0382 100 mcg
0.00
± 0.00
MEDI0382 200 mcg
0.00
± 0.00
MEDI0382 300 mcg
0.00
± 0.00
Day 19
Group
Value
95% CI
Placebo
0.00
± 0.00
MEDI0382 100 mcg
0.00
± 0.00
MEDI0382 200 mcg
3.68
± 12.75
MEDI0382 300 mcg
0.00
± 0.00
Day 47
Group
Value
95% CI
Placebo
0.00
± 0.00
MEDI0382 100 mcg
0.00
± 0.00
MEDI0382 200 mcg
0.00
± 0.00
MEDI0382 300 mcg
0.00
± 0.00
Mean Change From Baseline in the Percentage of Time in Hyperglycaemia Over 5 Days for 50 mcg Dose Level and 7 Days for Other Dose LevelsSecondary· Baseline (Day -8 to -2) and Days 1 to 5, 6 to 12, 13 to 19 and 41 to 47.
Hyperglycaemia was defined as blood glucose \>7.8 mmol/L or \>140 mg/dL. Continuous glucose monitoring used a device fitted to the upper arm by trained study site staff to measure and record interstitial glucose levels every 15 minutes. Analysis was based on 24-hour readings defined as the first available time point with a valid continuous glucose monitoring glucose reading. The change in the percentage time in hyperglycaemia from the last day of baseline continuous glucose monitoring over 5 days for 50 mcg MEDI0382 and 7 days for each of the dose levels (during titration) is presented, up to
Days 1 to 5
Group
Value
95% CI
Placebo
-1.43
± 10.26
MEDI0382 100 mcg
-42.52
± 13.46
MEDI0382 200 mcg
-38.68
± 18.97
MEDI0382 300 mcg
-34.74
± 18.24
Days 6 to 12
Group
Value
95% CI
Placebo
-8.97
± 26.12
MEDI0382 100 mcg
-48.35
± 16.01
MEDI0382 200 mcg
-50.81
± 18.97
MEDI0382 300 mcg
-51.82
± 16.73
Days 13 to 19
Group
Value
95% CI
Placebo
-6.09
± 19.10
MEDI0382 100 mcg
-53.25
± 16.47
MEDI0382 200 mcg
-52.33
± 20.96
MEDI0382 300 mcg
-47.50
± 20.67
Days 41 to 47
Group
Value
95% CI
Placebo
-0.40
± 22.70
MEDI0382 100 mcg
-42.37
± 17.22
MEDI0382 200 mcg
-43.44
± 18.26
MEDI0382 300 mcg
-51.25
± 17.12
Adverse events — posted to ClinicalTrials.gov
Time frame: Treatment-emergent AEs were collected from Day 1 of treatment up to 14 days after the last dose of IP (approximately 9 weeks)..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is a Phase 2a study designed to assess the safety and tolerability of MEDI0382 titrated up to a dose level of 100, 200 or 300 µg from 50 µg vs Placebo across 48 days in Japanese subjects.
The study D5674C00001 can be conducted with a reasonable expectation of safety and tolerability in Japanese T2DM patients. The design of this study has taken into account the known benefits and risks of GLP-1 receptor agonists and glucagon receptor agonists as well as the translatable effects observed in nonclinical studies of MEDI0382.
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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 AstraZeneca
Last refreshed: 23 December 2019
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/NCT03645421.