Type 2 Diabetes Mellitus MedDRA version: 20.0 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Product Code: MEDI0382
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: -
CAS Number: 1686108-82-6
Current Sponsor code: MEDI0382
Concentration unit: mg/ml milligram(s)
Sponsors
MedImmune Limited, a wholly owned subsidiary of AstraZeneca
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age = 18 and =65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: 1.History or presence of significant medical or psychological conditions, including substance dependence/abuse, or significant abnormalities in laboratory parameters or vital signs including ECG, which in the opinion of the investigator, would compromise the subject’s safety or successful participation in the study. As an example, severe anaemia (haemoglobin 180 mm Hg o Diastolic BP = 100 mm Hg after 10 minutes of seated rest and confirmed by repeated measurement at screening. Subjects who fail BP screening criteria may be considered for 24-hour ABPM at the discretion of the investigator. Subjects who maintain a mean 24-hour systolic BP = 180 or diastolic BP < 100 mm Hg with a preserv
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of MEDI0382 titrated up to a dose level of 300 µg on glucose control versus placebo after 32 days of treatment;Secondary Objective: • To characterise the safety profile and tolerability of MEDI0382 titrated up to a dose level of 300 µg during dosing and follow-up in subjects with T2DM and renal impairment • To assess the effects of MEDI0382 titrated up to a dose level of 300 µg on additional measures of glycaemic control versus placebo after 32 days of treatment • To assess the effects of MEDI0382 titrated up to a dose level of 300 µg on weight versus placebo after 32 days of treatment • To characterise the PK profile and immunogenicity of MEDI0382;Primary end point(s): Percentage change in glucose area under the curve (AUC) as measured by a standardised mixed meal tolerance test (MMTT) from baseline (Day -5) to the end of 32 days of treatment;Timepoint(s) of evaluation of this end point: Day 32 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Measures of safety and tolerability (AEs/SAEs, vital signs, postural blood pressure [BP] changes, ECG, laboratory test results) 2) Change in mean 24-hour pulse rate, systolic and diastolic blood pressure from baseline (Day -5) to the end of dosing at each dose level (Days 4, 11, 18, and 32) 3) Change in HbA1c from baseline (Day 1) to the end of 32 days of treatment (Day 32) 4) Change in fasting glucose from baseline (Day 1) to the end of 32 days of treatment (Day 32) 5) Change in percentage of time spent within a target glucose range of 70 mg/dL (3.9 mmol/L) to 180 mg/dL (10 mmol/L) over a 7-day period at baseline (Days -8 to - 2) to the final week of treatment (Days 26-32) 6) Percentage and absolute change in body weight from baseline (Day 1) to the end of 32 days of treatment (Day 33) 7) PK endpoints: AUC over a dosing duration, maximum observed concentration (Cmax), time to Cmax (Tmax), trough plasma concentration (Ctrough) 8) Development of anti-drug antibodies (ADA) and titre (if confirmed positive);Timepoint(s) of evaluation of this end point: 1) 7) 8) Refer to schedule of events 2) Days 4, 11, 18, and 32 3) 4) Day 32 5) Days 26-32 6) End of treatment | — |
Countries
United Kingdom
Contacts
Public ContactInformation Center
MedImmune Limited, a wholly owned subsidiary of AstraZeneca
Outcome results
None listed