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| Name | Class |
|---|---|
| Novo Nordisk A/S | INDUSTRY |
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Compared to human insulins analogue insulins offer the option of optimizing metabolism also in type 2 diabetes. Especially, fast acting insulin analogues lower postprandial glucose levels more effectively than human regular insulin. However, it is not known whether therapy with analogue insulins can also improve the subclinically impaired myocardial function in type 2 diabetes. This prospective, randomized, open long term study compared the effects of a basal-bolus insulin therapy with analogue insulins versus human insulins on metabolic control and systolic and diastolic myocardial function, testing the hypothesis that optimized postprandial glucose control improves cardiac function and cardiovascular risk.
This is a single centre, long term (24-48 months), therapy controlled and randomised study with blinded analysis of the ultrasound data in 120 patients with type 2 diabetes mellitus and with previous insulin therapy. After recruitment and informed consent, patients are randomized to two treatment arms according to a randomisation protocol which takes into account age and absence or presence of cardiovascular events in each patient's history.
In one treatment arm, the intensive insulin therapy is based on human insulin (insulin NPH and regular human insulin) while in the other arm, the intensive insulin therapy is based on analogue insulin (insulin detemir and insulin aspart). Both treatment arms will be titrated to identical glycemic goals (fasting blood glucose <110 mg/dL and post prandial blood glucose <150 mg/dL).
All patients will be updated in their skills of self medication by the departmental diabetic teaching programme und will receive life style instructions during each visit. Furthermore, they are encouraged to keep records of any episode of hypoglycemia throughout the study. Outpatient visits for metabolic control are every 3 months and ultrasound and blood tests every 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hum | Active Comparator | use of human regular insulin and NPH insulin |
|
| Ana | Active Comparator | use of insulin aspart and insulin detemir |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin aspart and detemir (NovoRapid, Levemir) | Drug | use of basal-bolus therapy with insulin aspart and detemir |
|
| Measure | Description | Time Frame |
|---|---|---|
| postprandial blood glucose at the end of the study and its change from baseline. | 24-48 months treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| diastolic myocardial function | 24-48 months treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Petra-Maria Schumm-Draeger, MD, PHD | Munich Academic Teaching Hospital Bogenhausen | Principal Investigator |
| Helene von Bibra, MD, PHD | Munich Academic Teaching Hospital Bogenhausen | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Staedt. Klinikum Muenchen Bogenhausen | Munich | Bavaria | 81925 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15111514 | Background | Bretzel RG, Arnolds S, Medding J, Linn T. A direct efficacy and safety comparison of insulin aspart, human soluble insulin, and human premix insulin (70/30) in patients with type 2 diabetes. Diabetes Care. 2004 May;27(5):1023-7. doi: 10.2337/diacare.27.5.1023. | |
| 15547039 | Background | von Bibra H, Hansen A, Dounis V, Bystedt T, Malmberg K, Ryden L. Augmented metabolic control improves myocardial diastolic function and perfusion in patients with non-insulin dependent diabetes. Heart. 2004 Dec;90(12):1483-4. doi: 10.1136/hrt.2003.020842. No abstract available. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D061267 | Insulin Aspart |
| D000069057 | Insulin Detemir |
| D007328 | Insulin |
| D007336 | Insulin, Isophane |
| C000006 | insulin, neutral |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| human regular insulin and NPH insulin (Actrapid, Protaphne) | Drug | basal-bolus therapy with human regular and NPH insulin |
|
|
| 10447514 | Background | Shaw JE, Hodge AM, de Courten M, Chitson P, Zimmet PZ. Isolated post-challenge hyperglycaemia confirmed as a risk factor for mortality. Diabetologia. 1999 Sep;42(9):1050-4. doi: 10.1007/s001250051269. |
| 26772807 | Derived | von Bibra H, Siegmund T, Kingreen I, Riemer M, Schuster T, Schumm-Draeger PM. Effects of analogue insulin in multiple daily injection therapy of type 2 diabetes on postprandial glucose control and cardiac function compared to human insulin: a randomized controlled long-term study. Cardiovasc Diabetol. 2016 Jan 16;15:7. doi: 10.1186/s12933-015-0320-2. |
| D004700 | Endocrine System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D049528 | Insulin, Long-Acting |
| D011384 | Proinsulin |