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recruitment difficulties
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This is an open multicentre, randomized study to compare two treatment arms. One arm called "intensification of multiple injections" in which the patient will receive one supplementary injection of LEVEMIR®: that is to say 5 injections per day, and an arm called "continuous insulin infusion" via an external pump with APIDRA®.
In the pump arm: a favorable effect in terms of improved insulin sensitivity, improved metabolic equilibrium, a decrease in the area under the baseline and prandial hyperglycemia curve noted during the continuous glycemia recording; an improvement in quality of life compared with treatment using multiple injections.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensified multiple injections | Other |
| |
| Pumps | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LEVEMIR | Drug |
| ||
| APIDRA |
| Measure | Description | Time Frame |
|---|---|---|
| Mixed measurement of insulin secretion and insulin resistance | Change from baseline insulin secretion and insuline resistance at 6 month after starting the treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Decrease in the time spent in baseline and prandial hyperglycemia | During the 6 months following initiation of the treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Besancon | Besançon | 25000 | France | |||
| CHU de Dijon |
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|
| Dijon |
| 21079 |
| France |
| ID | Term |
|---|---|
| D000069057 | Insulin Detemir |
| C479079 | insulin glulisine |
| 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 |
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