Phase 2
Completed N=61
Safety and Tolerability Study of MEDI0382 in Japanese Preobese or Obese Subjects With Type 2 Diabetes
Source: ClinicalTrials.gov NCT03645421 ↗Enrolled (actual)
61
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcomePrimary: Mean Change From Baseline in 24-Hour Heart Rate at Days 20 and 48 — -1.86; 6.65; 13.50; 15.80 beats/minute
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in 24-Hour Heart Rate at Days 20 and 48 |
-1.86; 6.65; 13.50; 15.80; -0.25; 7.87 | — |
| PRIMARY Mean Change From Baseline in 24-Hour Systolic and Diastolic Blood Pressure (BP) at Days 20 and 48 |
2.98; -4.09; -7.24; -2.48; 0.08; -2.27 | — |
| PRIMARY 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 48 |
2.45; -39.66; -31.16; -37.86 | <0.0001 sig |
| PRIMARY Mean Percentage Change From Baseline in Body Weight at Day 48 |
-0.82; -2.12; -3.34; -3.34 | 0.1476 |
| PRIMARY Mean Change From Baseline in Heart Rate Measured by Electrocardiogram (ECG) at Day 48. |
1.77; 4.24; 2.18; 6.27; -2.85; 1.84 | — |
| PRIMARY Number of Patients Who Experienced Adverse Events (AEs) |
6; 6; 11; 9; 0; 0 | — |
| SECONDARY Mean Change From Baseline in HbA1c at Day 48 |
-0.14; -1.23; -1.24; -0.90 | <0.0001 sig |
| SECONDARY Mean Change From Baseline in Fasting Plasma Glucose at Day 48 |
-0.40; -57.10; -60.98; -55.47 | <0.0001 sig |
| SECONDARY Mean Change From Baseline in Fructosamine at Day 48 |
-0.012; -0.083; -0.066; -0.061 | <0.0001 sig |
| SECONDARY Mean Change From Baseline in the Percentage of Time in Hyperglycaemia Over 24 Hours at Days 5, 12, 19 and 47 |
-3.23; -48.35; -33.71; -51.33; -11.72; -57.74 | — |
| SECONDARY Mean Change From Baseline in the Percentage of Time in Hypoglycaemia Over 24 Hours at Days 5, 12, 19 and 47 |
0.00; 0.00; 0.00; 6.28; 0.00; 0.00 | — |
| SECONDARY 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 Levels |
-1.43; -42.52; -38.68; -34.74; -8.97; -48.35 | — |
| SECONDARY Mean Change From Baseline in the Percentage of Time in Hypoglycaemia Over 5 Days for 50 mcg Dose Level and 7 Days for Other Dose Levels |
0.21; 0.06; 0.25; 5.50; 0.06; 0.90 | — |
| SECONDARY Mean Trough Plasma Concentration (Ctrough) of MEDI0382 up to Day 48 |
1.20; 1.22; 1.11; 1.47; 1.61; 1.56 | — |
| SECONDARY Number of Patients With Antidrug Antibody (ADA) Response to MEDI0382 |
0; 0; 0; 4; 5; 2 | — |
Eligibility Criteria
Inclusion Criteria
- Individuals whose HbA1c range of 7.0% to 10.5% (inclusive) at screening.
- Individuals who are diagnosed with T2DM
- Individuals whose current condition at enrolment (Visit 1) is drug naïve
- BMI within the range of 24 - 40 kg/m2 (inclusive) at screening
Exclusion Criteria
- Subjects with any of the following results at screening:
- Aspartate transaminase (AST) ≥ 2.5 × upper limit of normal (ULN)
- Alanine transaminase (ALT) ≥ 2.5 × ULN
- Total bilirubin (TBL) ≥ 2 × ULN
- Impaired renal function defined as estimated glomerular filtration rate (eGFR) ≤ 60 mL/minute/1.73 m2 at screening
- Participation in another clinical study with an investigational product administered in the last 30 days or 5 half-lives of the drug (whichever is longer) at the time of screening
Data sourced from ClinicalTrials.gov (NCT03645421). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.