Evaluate Efficacy, Safety and Tolerability of AZD1656 as Add-on Treatment to Metformin in Type 2 Diabetes Mellitus (TD2M) Patients
- Conditions
- E10-E10 Insulin-dependent diabetes mellitusInsulin-dependent diabetes mellitus
- Registration Number
- PER-120-09
- Lead Sponsor
- AstraZeneca AB,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• 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).
• 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 <115 g/L at enrolment, obtained from the central laboratory used in the study.
• History of psychiatric or somatic disease/condition (eg, gastrointestinal disease) that may interfere with the objectives of the study, as judged by the investigator.
• History or ongoing symptoms/signs of severe allergy/hypersensitivity as judged by the investigator.
• Known allergy to glipizide.
• History of malignancy within the last 5 years, excluding successful treatment of basal or squamous cell skin carcinoma or in-situ carcinoma of the cervix.
• Impaired renal function in terms of GFR<60 ml/min, based on Modification of Diet in Renal Disease Study Group (MDRD) calculationa.
• Past or present alcohol or drug abuse within the last 5 years or positive test in drugs of abuse screens.
• SBP >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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:AZD1656 is analyzed in a ANCOVA model (Glipized and Open Label is Not Included in the model), FAS Prior to Rescue<br><br>Measure:HbA1c: Change From Baseline to 4 Month<br>Timepoints:Baseline to 4th Month<br>
- Secondary Outcome Measures
Name Time Method