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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT #: 2007-003393-25 |
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Aim of the study is to compare two treatment regimens (insulin Lantus as basal insulin vs insulin NPH) plus oral antidiabetics in type 2 diabetic patients and confirm superiority of insulin glargine. Comparison is focused on: blood glucose (BG) variability of the two treatment regimens, quality of diabetes compensation (HbA1c, FBG/Fasting blood glucose), body weight development, dose of insulin and occurrence of symptomatic hypoglycaemia and other adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin glargine | Drug | once daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| The change in blood glucose variability | before start with insulin glargine treatment and at the end of the study |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of adverse events | From signing of informed consent to the end of study | |
| Development of diabetes compensation - fastig blood glucose and HbA1 | before starting therapy with Lantus and at the end of study |
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Inclusion Criteria:
Exclusion Criteria:
16. Patients included in other clinical studies
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 |
|---|---|---|
| Zuzana Priborska, MD | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis Administrative Office | Prague | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24563017 | Derived | Zdarska DJ, Kvapil M, Rusavy Z, Krcma M, Broz J, Krivska B, Kadlecova P. Comparison of glucose variability assessed by a continuous glucose-monitoring system in patients with type 2 diabetes mellitus switched from NPH insulin to insulin glargine: the COBIN2 study. Wien Klin Wochenschr. 2014 Apr;126(7-8):228-37. doi: 10.1007/s00508-014-0508-6. Epub 2014 Feb 22. |
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| Development of weight of patients | Before starting Lantus vs at the end of the study |
| Comparison of dose of insulins NPH vs Lantus | Before starting Lantus and at the end of the study |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000069036 | Insulin Glargine |
| 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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