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Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

•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

Exclusion Criteria

•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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the effectiveness of two insulin titration algorithms using long –acting insulin (insulin glargine, Lantus® or insulin detemir, Levemir®), based on absolute or percent increase of insulin titration dose dependent on changes in fasting blood glucose concentrations in subjects with type 2 diabetes mellitus (T2DM) treated with metformin or a DPP-4 inhibitor. ;Secondary Objective: not applicable;Primary end point(s): time until the subjects reach a fasting blood glucose concentration of =110 mg/dL;Timepoint(s) of evaluation of this end point: ongoing

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): a. 10-point blood glucose profile over 24 hours<br>b. Duration (days) in Hospital<br>;Timepoint(s) of evaluation of this end point: a. 10 time-points over 24 hours<br>b. at the end of the hospital stay