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The purpose of the study is to demonstrate, that there is no difference in metabolic control in patients with type 2 diabetes mellitus and therapy with human insulin with or without injection-meal-interval.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | with injection-meal-interval,cross over after 3 month, than without injection-meal-interval for 3 month |
|
| B | Experimental | without injection-meal-interval,cross over after 3 month, than with injection-meal-interval for 3 month |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| injection-meal-interval | Procedure | The patient injects human insulin (as Actrapid from NovoNordisc) as usual in their insulin routine. The injection is subcutaneous and the dosage is dependent on the blood glucose monitoring. Patients will inject insulin previous every meal, with the following differences:
Cross-over will occur to the other group after 12 weeks. The follow up is 28 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | Week 16 and 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Hypoglycemia | Week 16 and 28 | |
| Treatment satisfaction | week 16 and 28 | |
| Quality of Life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ulrich A Mueller, Professor | University of Jena, department of internal medicine III | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Friedrich-Schiller-University, department of internal medicine III | Jena | 07740 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23340895 | Derived | Muller N, Frank T, Kloos C, Lehmann T, Wolf G, Muller UA. Randomized crossover study to examine the necessity of an injection-to-meal interval in patients with type 2 diabetes and human insulin. Diabetes Care. 2013 Jul;36(7):1865-9. doi: 10.2337/dc12-1694. Epub 2013 Jan 22. | |
| 21219434 | Derived | Muller N, Kloos C, Frank T, Ristow M, Wolf G, Muller UA. Prevalence of injection-meal interval usage and its association with variables of metabolic control in patients with Type 1 and Type 2 diabetes. Diabet Med. 2011 Feb;28(2):223-6. doi: 10.1111/j.1464-5491.2010.03172.x. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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|
| week 16 and 28 |
| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |