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| ID | Type | Description | Link |
|---|---|---|---|
| Eudract #: 2005-000959-15 |
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Primary objective:
To assess quality of Life (QoL) changes and treatment satisfaction in a real life situation in patients with Type 2 diabetes inadequately controlled on a combination of oral antidiabetic drugs (OAD) plus Neutral Protamine Hagedrone (NHP) insulin treatment that are switched to insulin glargine.
Secondary objective:
To determine:
change in HbA1c, comparision of the incidence of symptomatic hypoglycemia and severe hypoglycemia before and after introduction of insulin glargine, change in weight, change in insulin dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | insulin glargine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin Glargine | Drug | Lantus (insulin glargine [rDNA origin] injection), individual dosing , subcutaneous injection, 100 IU/ml. Duration of treatment will be judge by the investigator. Last QoL assessed in the study will be 9 months after start of glargine treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| The fear of hypoglycaemia scale (HFS) | before the switch to insulin glargine and at 3 and 9 months of follow up. | |
| 12 - Item Well-Being Questionnaaire (WBQ12) | before the switch to insulin glargine and at 3 and 9 months of follow up. | |
| Glycaemic controll will be asessed by HbA1c values | week 12 and week 40 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of symptomatic hypoglycemia and severe hypoglycemia | sreening to follow-up phases |
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lists of inclusion and exclusion criteria:
Inclusion Criteria:
Exlusion criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Margareta Olsson-Birgersson | sanofi-aventis, Sweden | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis Administrative Office | Bromma | Sweden |
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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 |
|---|---|
| D000069036 | Insulin Glargine |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| D004700 | Endocrine System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |