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 range20 Years – 74 Years

SexALL

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.
✕. 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.

What they're measuring

Incidence of treatment-emergent adverse events (TEAEs)

Timeframe: Baseline until the follow-up period, 28 days post-last dose

Incidence of treatment-emergent serious adverse events (TESAEs)

Timeframe: Baseline until the follow-up period, 28 days post-last dose

Clinically important changes in 12-lead electrocardiogram (ECG)

Timeframe: Baseline until the follow-up period, 28 days post-last dose

Vital signs as measured by pulse rate (bpm)

Timeframe: Baseline until the follow-up period, 28 days post-last dose

Vital signs as measured by blood pressure (mmHg)

Timeframe: Baseline until the follow-up period, 28 days post-last dose

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

Physical examination (abnormality to be reported as part of adverse events)

Timeframe: Baseline until the follow-up period, 28 days post-last dose

Trial details

NCT IDNCT04208620

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-07-08

View on ClinicalTrials.gov More Type 2 Diabetes trials

Who can participate

Age range20 Years – 74 Years

SexALL

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.
✕. 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.

What they're measuring

Incidence of treatment-emergent adverse events (TEAEs)

Timeframe: Baseline until the follow-up period, 28 days post-last dose

Incidence of treatment-emergent serious adverse events (TESAEs)

Timeframe: Baseline until the follow-up period, 28 days post-last dose

Clinically important changes in 12-lead electrocardiogram (ECG)

Timeframe: Baseline until the follow-up period, 28 days post-last dose

Vital signs as measured by pulse rate (bpm)

Timeframe: Baseline until the follow-up period, 28 days post-last dose

Vital signs as measured by blood pressure (mmHg)

Timeframe: Baseline until the follow-up period, 28 days post-last dose

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

Physical examination (abnormality to be reported as part of adverse events)

Timeframe: Baseline until the follow-up period, 28 days post-last dose