None listed
Conditions
Interventions
Group 1 Type of group
200 mg AZD16S6 + Metformin
Group name:Group 7 Type of group
200 mg Open Label + Metformin
Sponsors
AstraZeneca AB,
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Provision of informed consent prior to any study specific procedures. • Male or female of non-childbearing potential (postmenopausal, and/or have undergone hysterectomy and/or bilateral oophorectomy or salpingectomy/tubal ligation) aged = 18. Women will be defined as postmenopausal if last menstruation period was >1 year ago and serum FSH and LH are within the postmenopausal range, or if age >50 years and with last menstruation period >2 years ago. • Body mass index between = 19 and = 42 kg/m2. • Clinical diagnosis of T2DM. • Treated with maximally tolerated dose of metformin (= 1500mg/day) for at least 10 weeks prior to enrolment. • Patients with HbA1c = 7.5 but = 10% at enrolment visit (Visit 1) (HbA1c value according to international DCCT standard and obtained from the central laboratory used in the study) can enter cohort 1. Patients with HbA1c between >10 % and <12 % can enter the open-label arm with AZD1656 (cohort 2) • Patients must have taken at least 75% of their metformin tablets during the run-in period (ie, from Visit 2 to Visit 3).
Exclusion criteria
Exclusion criteria: • Clinical diagnosis of Type 1 diabetes. • Positive test for Hepatitis B surface antigen or antibodies to HIV virus or antibodies to Hepatitis C virus. Results obtained from the central laboratory will be utilised. • Participation in weight loss programme (other than the lifestyle advice normally given to T2DM patients) or use of weight loss drugs (OTC or prescriptions) in the last 3 months • Participation in another clinical trial within 30 days prior to enrolment. • Unwilling or unable to perform self-monitoring of plasma glucose at home according to protocol. • Significant cardiovascular event within the last 6 months prior to enrolment (eg, myocardial infarction/acute coronary syndrome, revascularisation procedure, stroke or transient ischaemic attack) or heart failure New York Heart Association (NYHA) class III-IV. • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) laboratory results >3xULN at enrolment, obtained from the central laboratory used in the study. • Haemoglobin laboratory results 160 mmHg or DBP >95 mmHg at enrolment/screening. • Treatment with any other anti-diabetic agent than metformin during the last 10 weeks prior to enrolment/screening. • Proliferative retinopathy or other significant diabetes complications as judged by the investigator. • Use of warfarin or amiodarone within 3 months prior to enrolment (screening) and use of potent CYP450 inhibitors, eg, ketoconazole and/or macrolide antibiotics within 14 days before randomisation. • Use of anabolic steroids and systemic treatment with glucosteroids within 3 months before enrolment. Inhalation steroid treatment allowed. • Blood loss in excess of 450 mL 3 months prior to enrolment. • Intake of another investigational drug within 30 days (or at least 5 t1/2 of the drug, if longer than 30 days) before enrolment. • Prior exposure to GKAs. • Involvement in the planning and conduct of the study or staff at the investigational site. • Any other condition prohibiting the patient from participating in the study according to the protocol as judged by the investigator. • Previous bone marrow transplant (applicable only for genetic sampling). • Whole blood transfusion within 120 days of the date of genetic sample collection (applicable only for genetic sampling). • Unable or unwilling to use basal night-time insulin as rescue treatment during the study period in case of hyperglycaemia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:AZD1656 is analyzed in a ANCOVA model (Glipized and Open Label is Not Included in the model), FAS Prior to Rescue Measure:HbA1c: Change From Baseline to 4 Month Timepoints:Baseline to 4th Month | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:AZD1656 is analyzed in a ANCOVA model (Glipized and Open Label is Not Included in the model), FAS Prior to Rescue. Measure:FPG: to Evaluate Change From Baseline to 4 Month, Compared With Placebo, FAS Prior to Rescue Timepoints:baseline to 4 month ; Outcome name:AZD1656 is analyzed in a ANCOVA model (Glipized and Open Label is Not Included in the model), FAS Prior to Rescue. Measure:SMPG: Change From Baseline to 4 Month, Compared With Placebo, FAS Prior to Rescue. Timepoints:baseline to 4 month ; Outcome name:The relative change in AUC, AUC FAS Prior to Rescue, FAS prior to rescue, FAS prior to rescue Measure:OGTT/Plasma Glucose/Insulin/C-peptide/Pro-insulin/Insulin Timepoints:baseline to 4 month ; Outcome name:Number of responders ≤ 7, FAS prior to rescue. Measure:HbA1c ≤ 7 Timepoints:baseline to 4 month ; Outcome name:Geometric mean ratio (safety analysis set, regardless of rescue) and a 95 % CI Measure:LDL-C: Mean Ratio, HDL-C: Change From Baseline, Total Cholesterol: Change From Baseline, C-reactive Protein: Change From Baseline Timepoints:baseline to 4 month | — |
Countries
Chile, Germany, Hungaria, Latovia, Lithuania, Mexico, Peru, Poland, Romania, Sweden, United Kindgdom
Contacts
Public ContactRosa Adela Chamorro
ICON CLINICAL RESEARCH PERU S.A.
Outcome results
None listed