Type 2 Diabetes
Conditions
Interventions
investigational material(s)
Generic name etc : Cotadutide
INN of investigational material : -
Therapeutic category code : 249 Other hormone preparations (including antihormone preparations)
Dosage and
Sponsors
AstraZeneca KK
MedImmune LLC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provision of signed and dated written informed consent prior to any mandatory study specific procedures, sampling, and analyses. 2. Subject must be 20 to 74 years of age at screening. 3. HbA1c range of 6.5% to 8.5% at screening and run-in visit. 4. Willing and able to self-inject investigational product for the duration of the study. 5. Individuals who are diagnosed with T2DM and have inadequate glycaemic control with diet and exercise. 6. Individuals whose current condition at enrolment are drug naive defined as - Never received medical treatment for diabetes (insulin and/or other anti-diabetic agents [oral or injection]) OR - Received medical treatment for diabetes for less than 30 days since diagnosis.Subjects also should not have a history of insulin therapy within 2 weeks of screening (with the exception of insulin therapy during a hospitalization for other causes or use in gestational diabetes) OR - Previously received medical treatment for diabetes but have not been treated within 6 weeks of randomization. 7. BMI within the range 25 to 35 kg/m2 at screening. 8. Negative pregnancy test for female subjects. 9. Female subjects of childbearing potential who are sexually active with a male partner must be willing to use at least one highly effective method of contraception from screening and up to 4 weeks after the last dose of investigational product.
Exclusion criteria
Exclusion criteria: 1. Subjects with any of the following results at screening and run-in visit 2. 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 procedure 3. Acute pancreatitis at screening or history of chronic pancreatitis or serum triglyceride levels > 11 mmol/L (1000 mg/dL) at screening. 4. 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. 5. 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. - Aspartate transaminase (AST) 3 or more x upper limit of normal (ULN) - Alanine transaminase (ALT) 3 or more x ULN - Total bilirubin (TBL) 2 or more x ULN 6. Impaired renal function defined as estimated glomerular filtration rate (GFR) 140 mmHg Diastolic BP 90 mmHg or less For age > 55 years; Systolic BP > 150 mmHg Diastolic BP 90 /mmHg or less 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 15% or day time BP 450 msec, or family history of long QT-segment at screening or run-in visit. 11. PR (PQ) interval prolongation (> 220 msec), intermittent second (Wenckebach block while asleep is not exclusive), or third-degree atrioventricular (AV) block, or AV dissociation at screening or run-in visit. 12. Persistent or intermittent complete bundle branch block. A QRS duration < 120 msec is acceptable if there is no evidence of ventricular hypertrophy or preexcitation at screening or run-in visit. 13. Abnormal findings during the exercise stress test, such as chest pain, dyspnoea, presyncope, arrhytmias, signs of cardiac ischemia on ECG as judged by the investigator. 14. History of, unstable angina pectoris, myocardial infarction, transient ischemic attack, or stroke, or subjects who have undergone percutaneous coronary intervention or a coronary artery bypass graft or who are due to undergo these procedures at the time of screening. 15. Severe congestive heart failure (New York Heart Association Class III or IV
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety - | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy pharmacokinetics - | — |
Countries
Japan
Outcome results
None listed