Safety and Tolerability Study of Cotadutide in Japanese Obese Subjects With Type 2 Diabetes Melitus
- Registration Number
- NCT04208620
- Lead Sponsor
- AstraZeneca
- Brief Summary
This is a Phase 1 study designed to assess the safety and tolerability of MEDI0382 (Cotadutide) in Japanese T2DM patients.
- Detailed Description
This is a randomized, blinded, placebo-controlled study designed to evaluate the safety, tolerability, PK and efficacy of ascending doses of Cotadutide in Japanese obese subjects with T2DM. Approximately 20 subjects will be screened in total and 16 subjects will be randomized to Cotadutide or placebo in a 3:1 ratio. Those subjects who receive Cotadutide will be titrated up to HCTD. The study has a 2-week screening period, a run-in period of 9 days and an up to 7-week up-titration treatment period followed by a 3-week treatment extension period (if applicable), followed by a 28-day follow-up period.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo administered subcutaneously Cotadutide Cotadutide Cotadutide administered subcutaneously
- Primary Outcome Measures
Name Time Method Incidence of treatment-emergent adverse events (TEAEs) Baseline until the follow-up period, 28 days post-last dose To assess the safety and tolerability of Cotadutide
Incidence of treatment-emergent serious adverse events (TESAEs) Baseline until the follow-up period, 28 days post-last dose To assess the safety and tolerability of Cotadutide
Clinically important changes in 12-lead electrocardiogram (ECG) Baseline until the follow-up period, 28 days post-last dose To assess the safety and tolerability of Cotadutide
Vital signs as measured by pulse rate (bpm) Baseline until the follow-up period, 28 days post-last dose To assess the safety and tolerability of Cotadutide
Vital signs as measured by blood pressure (mmHg) Baseline until the follow-up period, 28 days post-last dose To assess the safety and tolerability of Cotadutide
ABPM (Ambulatory blood pressure monitoring) to measure pulse rate (bpm) and blood pressure (mmHg) Baseline until the follow-up period, 28 days post-last dose To assess the safety and tolerability of Cotadutide
Physical examination (abnormality to be reported as part of adverse events) Baseline until the follow-up period, 28 days post-last dose To assess the safety and tolerability of Cotadutide
Clinical laboratory evaluations Baseline until the follow-up period, 28 days post-last dose To assess the safety and tolerability of Cotadutide
- Secondary Outcome Measures
Name Time Method Change in percentage time spent in hyperglycemia (> 140 mg/dL) At baseline through end of study, 98 days in total To assess the effect of Cotadutide on glucose control as measured by continuous glucose monitoring (CGM)
Change in percentage time spent in normoglycemia (70 -140 mg/dL) At baseline through end of study, 98 days in total To assess the effect of Cotadutide on glucose control as measured by continuous glucose monitoring (CGM)
Change in percentage time spent in clinically significant hypoglycemia (< 54 mg/dL) At baseline through end of study, 98 days in total To assess the effect of Cotadutide on glucose control as measured by continuous glucose monitoring (CGM)
Change in estimated hemoglobin A1c (HbA1c) At baseline through end of study, 98 days in total To assess the effect of Cotadutide on glucose control as measured by continuous glucose monitoring (CGM)
Change in fasting plasma glucose (mg/dL) At baseline through end of study, 98 days in total To assess the effect of Cotadutide on glucose control as measured by additional measrues of glucose control
Change in HbA1c At baseline through end of study, 98 days in total To assess the effect of Cotadutide on glucose control as measured by additional measrues of glucose control
Percentage change in body weight At baseline through end of study, 98 days in total To assess the effect of Cotadutide on body weight
Absolute change in body weight (kg) At baseline through end of study, 98 days in total To assess the effect of Cotadutide on body weight
Proportion of subjects achieving > 5% body weight loss At baseline through end of study, 98 days in total To assess the effect of Cotadutide on body weight
Area under the concentration-time curve (AUC) during the dosing interval (AUCtau) Day1 of Up-titration treatment period to Day 21 of Treatment extension period, total of up to 10 weeks To characterize the PK profile of Cotadutide
Maximum observed concentration (Cmax) Day1 of Up-titration treatment period to Day 21 of Treatment extension period, total of up to 10 weeks To characterize the PK profile of Cotadutide
Time to Cmax (tmax) Day1 of Up-titration treatment period to Day 21 of Treatment extension period, total of up to 10 weeks To characterize the PK profile of Cotadutide
Trough plasma concentration (Ctrough) Day1 of Up-titration treatment period to Day 21 of Treatment extension period, total of up to 10 weeks To characterize the PK profile of Cotadutide
Anti-drug antibodies (ADAs) to Cotadutide At baseline through end of study, 98 days in total To characterize the immunogenicity of Cotadutide
Change in average glucose levels (mg/dL) At baseline through end of study, 98 days in total To assess the effect of Cotadutide on glucose control as measured by continuous glucose monitoring (CGM)
Change in coefficient of variation At baseline through end of study, 98 days in total To assess the effect of Cotadutide on glucose control as measured by continuous glucose monitoring (CGM)
Trial Locations
- Locations (1)
Research Site
🇯🇵Suita-shi, Japan