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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT Number: 2007-006109-26 |
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| Name | Class |
|---|---|
| IKFE Institute for Clinical Research and Development | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin glargine | Active Comparator | Insulin glargine, dose individually adapted to reach treatment goal (FBG < 100 mg/dL) |
|
| NPH Insulin | Active Comparator | NPH Insulin, dose individually adapted to reach treatment goal (FBG < 100 mg/dL) |
|
| Insulin detemir | Active Comparator | Insulin detemir, dose individually adapted to reach treatment goal (FBG < 100 mg/dL) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin Glargin | Drug |
| ||
| NPH insulin |
| Measure | Description | Time Frame |
|---|---|---|
| postprandial dynamics of intact proinsulin secretion after standardized test meals (AUC for two hours after dinner) | 12 +/- 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| AUC for intact proinsulin levels for two hours after a standardized test meal (breakfast and lunch) | 12 +/- 2 weeks | |
| increase of intact proinsulin after breakfast (BF), lunch (LU) and dinner (DI) | 12 +/- 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ikfe GmbH, Clinic Department | Mainz | RLP | 55116 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20415692 | Derived | Forst T, Larbig M, Hohberg C, Forst S, Diessel S, Borchert M, Roth W, Pfutzner A. Adding insulin glargine vs. NPH insulin to metformin results in a more efficient postprandial beta-cell protection in individuals with type 2 diabetes. Diabetes Obes Metab. 2010 May;12(5):437-41. doi: 10.1111/j.1463-1326.2010.01209.x. |
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|
| Insulin detemir | Drug |
|
| metformin | Drug | metformin (2000 mg/day) |
|
| Ratio of exogenous insulin vs. endogenous insulin (measurements of glargine, NPH Insulin, detemir and human insulin levels) | 12 +/- 2 weeks |
| Postprandial endothelial function measured as postischaemic response in LDF measurements (after BF, LU, DI) | 12 +/- 2 weeks |
| Postprandial change in and AUC for hs CRP (after BF, LU, DI) | 12 +/- 2 weeks |
| Postprandial change in and AUC for ADMA (after BF, LU, DI) | 12 +/- 2 weeks |
| Postprandial increase in and AUC for glucose levels (after BF, LU, DI) | 12 +/- 2 weeks |
| Changes in FBG | 12 +/- 2 weeks |
| Changes in 8-point BG profiles | 12 +/- 2 weeks |
| Percentage of patients reaching the treatment goal | 12 +/- 2 weeks |
| Insulin dosage per kg body weight to reach treatment goal | 12 +/- 2 weeks |
| ID | Term |
|---|---|
| D007336 | Insulin, Isophane |
| D000069057 | Insulin Detemir |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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