The aim of the study is to show that treatment with Glargine will lead to an improvement in beta cell function especially within times of maximal beta cell stress occurring after a meal. For this reason three different standardized test meals (breakfast, lunch, dinner) will be performed and the postprandial secretion of intact proinsulin levels will be measured. These measurements will be performed with patients treated in combination with metformin and insulin glargine versus metformin plus NPH insulin (within the core study) and if significant difference is observed, with a third treatment arm with metformin plus insulin detemir. Hypothesis is that the area under the curve (AUC) intact proinsulin levels within 2 hours after test meal dinner of metformin plus insulin glargin differs from AUC intact proinsulin levels of metformin plus NPH insulin.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
ikfe GmbH, Clinic Department
Mainz, RLP, Germany
postprandial dynamics of intact proinsulin secretion after standardized test meals (AUC for two hours after dinner)
Time frame: 12 +/- 2 weeks
AUC for intact proinsulin levels for two hours after a standardized test meal (breakfast and lunch)
Time frame: 12 +/- 2 weeks
increase of intact proinsulin after breakfast (BF), lunch (LU) and dinner (DI)
Time frame: 12 +/- 2 weeks
Ratio of exogenous insulin vs. endogenous insulin (measurements of glargine, NPH Insulin, detemir and human insulin levels)
Time frame: 12 +/- 2 weeks
Postprandial endothelial function measured as postischaemic response in LDF measurements (after BF, LU, DI)
Time frame: 12 +/- 2 weeks
Postprandial change in and AUC for hs CRP (after BF, LU, DI)
Time frame: 12 +/- 2 weeks
Postprandial change in and AUC for ADMA (after BF, LU, DI)
Time frame: 12 +/- 2 weeks
Postprandial increase in and AUC for glucose levels (after BF, LU, DI)
Time frame: 12 +/- 2 weeks
Changes in FBG
Time frame: 12 +/- 2 weeks
Changes in 8-point BG profiles
Time frame: 12 +/- 2 weeks
Percentage of patients reaching the treatment goal
Time frame: 12 +/- 2 weeks
Insulin dosage per kg body weight to reach treatment goal
Time frame: 12 +/- 2 weeks
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