Establishing Cardiovascular Biomarkers to Define Preferred Lantus® Use
Insulin-requiring Type 2 Diabetes Mellitus
About this trial
This is an interventional treatment trial for Insulin-requiring Type 2 Diabetes Mellitus focused on measuring Type 2 Diabetes mellitus, NPH insulin, Insulin Glargine, cardiovascular biomarkers, hsCRP, adiponectin, intact proinsulin, cardiovascular risk
Eligibility Criteria
Inclusion Criteria:
- Give written informed consent.
- Patient consents that his/her family physician/diabetologist will be informed of trial participation
- Type-2 diabetes mellitus ≥ 1 year of diagnosis (male and female)
- Experienced in self blood glucose measurement for ≥ 3 months.
- HbA1c ≤ 9% and >6,5%
- BMI > 30 kg/m²
- Age ≥ 18 years
- Waist circumference > 88 cm (female) and > 102 cm (male)
- NPH insulin treatment plus 1 or 2 OAD (except TZD)
Exclusion Criteria:
- History of drug or alcohol abuse within the last five years prior to screening
- Anamnestic history of hypersensitivity to the study drugs (or any component of the study drug) or to drugs with similar chemical structures
- History of severe or multiple allergies
- Treatment with any other investigational drug within 3 months prior to screening
- Progressive fatal disease
- History of significant cardiovascular, respiratory, gastrointestinal, hepatic (ALAT and/or ASAT > 3 times the normal reference range), renal (creatinine > 1.3 mg/dl in women and >1.6 mg/dl in men), neurological, psychiatric and/or hematological disease as judged by the investigator
- Pregnant or lactating women
- Sexually active women of childbearing potential not consistently and correctly practicing birth control by implants, injectables, combined oral contraceptives, hormonal intrauterine devices (IUDs), sexual abstinence or vasectomized partner
- Treatment with GLP1-analog or Thiazolidinediones (TZD)
- hsCRP > 10 mg/l (by rapid test at screening visit).
- Lack of compliance or other similar reason that, according to investigator, precludes satisfactory participation in the study
- Type 1 Diabetes mellitus
- Patients already treated with intensified conventional insulin therapy.
Sites / Locations
- ikfe GmbHRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Active Comparator
Experimental
Experimental
NPH insulin + insulin glulisine
NPH insulin + human insulin
Insulin glargine + insulin glulisine
Insulin Glargine + Human insulin
Patients will be randomized to be treated with NPH insulin + Insulin Glulisine for 24 weeks.
Patients will be randomized to be treated with NPH insulin + human insulin for 24 weeks.
Patients will be randomized to be treated with insulin glargine + insulin glulisine for 24 weeks.
Patients will be randomized to be treated with insulin glargine + human insulin for 24 weeks.