Diabetes mellitus Type II MedDRA version: 9.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus
Conditions
Sponsors
GWT-TUD GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients with Type II Diabetes mellitus (less than 5 years) - Age between 35 and 75 - HbA1C > 6,5% =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Treatment with more than one OAD - Treatment with 1 OAD within the last 6 weeks - Treatment with insuline - History of cardiovascular disease 2,5 times of normal range) or alcohol intoxication - Significant renal diseases (Kreatinin >1,2 mg/dl or Kreatinin-Clearance<60ml/min) - Circumstances which can cause renal insufficiency, e.g. dehydration, severe infections, shock - Treatment with systemic, oral or injectable Corticosteroids - Diseases of the adrenal gland, hypophysis, thyroid gland, which are not appropriate for the study procedure (investigators estimation) - Intravascular administration of contrast agents containing iodine - Diabetic ketoacidosis - Acute or chronic diseases that can cause tissue hypoxie like cardiac or respiratory insufficiency, myocardic infarct, shock - Known allergic or hypersensitiv reaction to one of the study drug or to drugs with similar chemical structures - Lack of compliance or other similar reason, that according to investigator, precludes satisfactory participation of the study - Participation in another clinical trial within the last 4 weeks - History of drug or alcohol abuse or psychological sickness that does not allow the subject to understand the nature and procedures of the study - Pregnant and lactating women - Women of childbearing potential not actively and consistently practicing birth control by using a medically accepted device or therapy (error rate <1%)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: - Protection of B cells (HbA1c, C-Peptide, Proinsulin) - Glycemic variability (standard deviation, MAGE=mean amplitude of glucose excursions) - Glycemic Load - Free fatty acids - Antiinflammatory effect of insuline (hsCRP, PAI-1, Leucocytes) - Effect on endothelial function (Laser-Doppler O2C) - Renal effects (Microalbuminurie) - Hypoglycemic risk (time < 3mmol glucose) ;Primary end point(s): AUC within 2 h (postprandial) [mmol/L/time] before and after treatment (after 36 weeks) with Insuline glargin as well as with Metformin.;Main Objective: To compare the treatment of an early Type II Diabetes mellitus with Insuline instead of the conventional treatment with Metformin. Evaluation of efficacy and safety of an early Diabetes mellitus Type II therapy with Insuline glargine as first line drug compared to treatment with Metformin described by the Area Under Curve (AUC) [mmol/L/time] measured with continous glucose monitoring. | — |
Countries
Germany
Outcome results
None listed