A randomized, controlled, prospective trial examining the effectiveness of two insulin titration algorithms of long acting insulin (insulin glargine, Lantus® or insulin detemir, Levemir®) in subjects with Type 2 Diabetes mellitus treated with metformin or DPP4 inhibitors

Diabeteszentrum Bad Lauterberg0 个研究点开始时间: 2014年3月10日最近更新: 2016年12月12日

适应症

试验速览

暂无简介。

•Type 2 diabetes
•Male and female
•Insulin naïve or treated with insulin detemir or -glargine
•On a stable regimen of metformin or DPP-4 inhibitor monotherapy
•Fasting plasma glucose: =160mg/dL
•Age: 30 = age = 75 years
•BMI: 20 = BMI = 40 kg•m-2
•Women of childbearing potential with use highly effective” methods of contraception (for example, a state after surgical sterilization, hormonal intrauterine devices (coil), oral hormonal contraceptives, sexual abstinence or a surgically sterilized partner).
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 75
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 25

•Subjects with type 1 diabetes, maturity onset diabetes of the young (MODY) or secondary forms of diabetes such as due to pancreatitis
•Patients who suffered from several severe episodes of hypoglycemia in the past 6 month
•Patients with preexisting coronary artery disease and signs of coronary ischemia (symptoms, ECG changes under exercise, pathological stress echocardiogram or myocard scintigram), cerebral artery disease (symptoms of cerebral ischemia, i.e. Z.n.TIA or >50% stenosis), or proliferative retinopathy
•Treatment with any hyperglycaemic medication other than metformin or DPP-4 inhibitor or long-acting insulin
•Indications of renal impairment (Creatinine clearance <60 ml/min)
•History of diabetic ketoacidosis
•Indications of pancreatitis
•Indications of liver insufficiency
•Patients on systemic corticosteroids
•Systolic blood pressure >180 mmHg
•Diastolic blood pressure >110 mmHg
•Female who is pregnant or intends to become pregnant
•Participation in any other clinical trial within 3 months prior to screening (information gathered through personal history taken

发起方

Diabeteszentrum Bad Lauterberg