Type 2 Diabetes mellitus MedDRA version: 17.0 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Sponsors
Diabeteszentrum Bad Lauterberg
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): a. 10-point blood glucose profile over 24 hours b. Duration (days) in Hospital ;Timepoint(s) of evaluation of this end point: a. 10 time-points over 24 hours b. at the end of the hospital stay | — |
Countries
Germany
Contacts
Public ContactProf. Dr. Nauck
Diabeteszentrum Bad Lauterberg
Outcome results
None listed