Safety and Tolerability Study of Cotadutide in Japanese Obese Subjects With Type 2 Diabetes Melitus (NCT04208620) | Clinical Trial Compass
CompletedPhase 1
Safety and Tolerability Study of Cotadutide in Japanese Obese Subjects With Type 2 Diabetes Melitus
Japan16 participantsStarted 2020-01-21
Plain-language summary
This is a Phase 1 study designed to assess the safety and tolerability of MEDI0382 (Cotadutide) in Japanese T2DM patients.
Who can participate
Age range
20 Years – 74 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Provision of signed and dated written informed consent prior to any mandatory study specific procedures, sampling, and analyses.
. Subject must be 20 to 74 years of age at screening.
. HbA1c range of 6.5% to 8.5% at screening and run-in visit.
. Willing and able to self-inject investigational product for the duration of the study.
. Individuals who are diagnosed with T2DM and have inadequate glycaemic control with diet and exercise.
. Individuals whose current condition at enrolment are drug naïve defined as
. BMI within the range 25 to 35 kg/m2 at screening.
. Negative pregnancy test for female subjects.
Exclusion criteria
. Subjects with any of the following results at screening and run-in visit
. History of, or any existing condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product, put the subject at risk, influence the subject's ability to participate or affect the interpretation of the results of the study and/or any subject unable or unwilling to follow study procedures.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of treatment-emergent adverse events (TEAEs)
Timeframe: Baseline until the follow-up period, 28 days post-last dose
2
Incidence of treatment-emergent serious adverse events (TESAEs)
Timeframe: Baseline until the follow-up period, 28 days post-last dose
3
Clinically important changes in 12-lead electrocardiogram (ECG)
Timeframe: Baseline until the follow-up period, 28 days post-last dose
4
Vital signs as measured by pulse rate (bpm)
Timeframe: Baseline until the follow-up period, 28 days post-last dose
5
Vital signs as measured by blood pressure (mmHg)
Timeframe: Baseline until the follow-up period, 28 days post-last dose
6
ABPM (Ambulatory blood pressure monitoring) to measure pulse rate (bpm) and blood pressure (mmHg)
Timeframe: Baseline until the follow-up period, 28 days post-last dose
7
Physical examination (abnormality to be reported as part of adverse events)
. Acute pancreatitis at screening or history of chronic pancreatitis or serum triglyceride levels \> 11 mmol/L (1000 mg/dL) at screening.
. Significant inflammatory bowel disease, gastroparesis or other severe disease or surgery affecting the upper GI tract (including weight-reducing surgery and procedures), which may affect gastric emptying or could affect the interpretation of safety and tolerability data.
. Significant hepatic disease (except for NASH or non-alcoholic fatty liver disease without portal hypertension or cirrhosis) and/or subjects with any of the following results at screening or run-in visit.
. Impaired renal function defined as estimated glomerular filtration rate (GFR) \< 60 mL/minute/1.73m2 at screening or run-in visit (GFR estimated according to Modification of Diet in Renal Disease \[MDRD\] using MDRD Study Equation IDMS-traceable \[International System of Units (SI)\]).
. Poorly controlled hypertension defined as, For age ≤ 55 years; Systolic BP \> 140 mmHg Diastolic BP ≥ 90 mmHg For age \> 55 years; Systolic BP \> 150 mmHg Diastolic BP ≥ 90 mmHg After 10 minutes of supine rest and confirmed by repeated measurement at screening or run-in visit. Subjects who fail BP screening criteria may be considered for 24-hour or day time ABPM at the discretion of the investigator. Subjects who maintain a mean 24-hour BP \< 130/80 mmHg with a preserved nocturnal dip of \> 15% or day time BP \< 135/85 mmHg will be considered eligible
. Resting heart rate is ≥ 80 bpm at screening or run-in visit.
Timeframe: Baseline until the follow-up period, 28 days post-last dose
8
Clinical laboratory evaluations
Timeframe: Baseline until the follow-up period, 28 days post-last dose