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Primary objective:
To show an improvement in HbA1c control after 4 months of treatment with insulin glargine + Oral Anti Diabetic (OAD) in patients previously uncontrolled on premixed insulin (with OAD)
Secondary objective:
Improvement of Fasting blood glucose (FPG) after 4 months treatment (% of patients treated to target HbA1c ≤7.0% and/or FBG≤6.0mmol/L). Frequency of hypoglycemic episodes, quality of life with basal+ OAD regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin Glargine | Drug | Once daily and up-titrate accordingly |
|
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c values | At baseline and 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events including hypoglycemia | From the beginning to the end of the study |
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Inclusion Criteria:
Exclusion 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 |
|---|---|---|
| Rui Yan Ding | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis Administrative Office | Shanghai | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35943899 | Derived | Yang W, Du J, Zhang M, Hou J, Zhang X, Cui N. Predictors of HbA1c reduction and hypoglycemia in type 2 diabetes mellitus individuals switching from premixed to basal insulin: an exploratory analysis of optimization study. Curr Med Res Opin. 2022 Nov;38(11):1807-1814. doi: 10.1080/03007995.2022.2105538. Epub 2022 Aug 9. |
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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 |