Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MEDI0382 100 μg · 1 trial · 1 indication
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.
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.
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.
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 \[LOCF\]).
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.
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.
| Arm | Type | Description |
|---|---|---|
| placebo | PLACEBO_COMPARATOR | Placebo per day,SC injection on 48 days. |
| MEDI0382 100μg | EXPERIMENTAL | 50 μg/day,SC injection on the first 5 days and 100 μg/day,SC injection on 43 days |
| MEDI0382 200μg | EXPERIMENTAL | 50 μg/day,SC injection on the first 5 days, 100 μg/day,SC injection on 7 days and 200 μg/day,SC injection on 36 days. |
| MEDI0382 300μg | EXPERIMENTAL | 50 μg/day,SC injection on the first 5 days, 100 μg/day,SC injection on 7 days, 200 μg/day,SC injection on 7 days and 300 μg/day,SC injection on 29 days |
| Name | Type | Description |
|---|---|---|
| MEDI0382 100 μg | DRUG | Solution for injection in 1.0 mL pre-filled syringe, 100 μg per dose, 1 dose |
| MEDI0382 200 μg | DRUG | Solution for injection in 1.0 mL pre filled syringe 200 μg per dose, 1 dose |
| MEDI0382 300 μg | DRUG | Solution for injection in 1.0 mL pre filled syringe, 300 μg per dose, 1 dose |
| PlaceboA | DRUG | 1.0 mL liquid formulation per Vial |
| MEDI0382 50 ug | DRUG | Solution for injection, 1.0 mL per vial, 50 ug |
| PlaceboB | DRUG | Solution for injection in 1.0 mL pre-filled syringe. |
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: ...
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MEDI0382 100 μg is an investigational small molecule being developed for the treatment of Type 2 Diabetes. It is currently in Phase 2 clinical development and has been studied in a completed trial involving Japanese preobese or obese subjects with Type 2 Diabetes.
MEDI0382 100 μg is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company is conducting clinical research on this investigational drug for Type 2 Diabetes.
MEDI0382 100 μg is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety and efficacy for the treatment of Type 2 Diabetes.
MEDI0382 100 μg has been studied in one completed Phase 2 clinical trial with the identifier NCT03645421. This trial was titled 'Safety and Tolerability Study of MEDI0382 in Japanese Preobese or Obese Subjects With Type 2 Diabetes' and enrolled 61 participants in Japan.
MEDI0382 100 μg is a specific dose of the investigational drug MEDI0382. The 100 μg designation refers to the dose strength being studied. MEDI0382 is being developed by AstraZeneca PLC for the treatment of Type 2 Diabetes.