Diabetes mellitus Type 2 MedDRA version: 9.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus
Conditions
Interventions
Trade Name: Lantus
Pharmaceutical Form: Solution for injection
Trade Name: Levemir
Pharmaceutical Form: Solution for injection
Trade Name: Metformin-ratiopharm
Pharmaceutical Form: Film-coated table
Sponsors
Institut für Klinische Forschung und Entwicklung (ikfe) GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Type 2 Diabetes mellitus according to the ADA criteria 2. HbA1c between 6.5 % and 8.5 % 3. Monotherapy with metformin or combined with sulfonylurea in a stable dosage within the last 3 months 4. Age between 40 and 75 years 5. Fasting intact proinsulin level > 7 pmol/L 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Type 1 Diabetes mellitus 2. Pre-Treatment with insulin within the last 3 months prior to screening 3. Pre-Treatment with PPARy-agonists (glitazones) within the last 3 months prior to screening 4. Major micro- or macrovascular complications as judged by the investigator 5. Planned or anticipated change in antidiabetic and/or concomitant medication during study participation 6. BMI > 45 kg/m² 7. Hypokalemia (K 3 times the normal reference range), renal (creatinine > 1.3 mg/dL in women and > 1.7 mg/dL in men), neurological, psychiatric and/or haematological disease as judged by the investigator 14. Pregnancy or breast feeding 15. Sexually active women of childbearing potential not actively and consistently practicing birth control by using a medically accepted device or therapy 16. Lack of compliance or other similar reason, that according to investigator, precludes satisfactory participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to evaluate beta-cell-function and beta-cell-stress as measured by the postprandial dynamics of intact proinsulin secretion after standardized test meals during standardized 12 hours inpatient treatment days;Secondary Objective: The secondary objectives are to evaluate the ratio of exogenous insulin vs. endogenous insulin, the postprandial increase in hs CRP, ADMA, glucose after treatment with insulin glargine compared with insulin detemir. Further secondary objectives are changes in fasting blood glucose, changes in 8-Point- blood glucose profiles, percentage of patients reaching the treatment goal and the insulin dosage per kg body weight to reach treatment goal. ;Primary end point(s): intact proinsulin secretion | — |
Countries
Germany
Outcome results
None listed