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The purposes of the study is to determine whether blood sugar control is different between Lantus and a third oral anti-diabetic agent when added to patients who fail a thiazolidinedione and sulfonylurea or metformin combination.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lantus (insulin glargine [rDNA origin] injection) | Drug | |||
| Metformin | Drug | |||
| Glyburide | Drug | |||
| Thiazolidinedione | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the difference in glycemic control as measured by HbA1C between substituting the TZD with insulin glargine and adding a third oral agent in patients who fail a TZD/sulfonylurea or TZD/metformin combination therapy | During the Study Conduct |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of hypoglycemia | During the study conduct | |
| Change in fasting plasma glucose | During the study conduct | |
| Percentage of patients achieving HbA1C less than or equal to 7% |
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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 |
|---|---|---|
| Doug Green | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aventis | Bridgewater | New Jersey | 08807 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26281972 | Derived | Hollander P, Sugimoto D, Vlajnic A, Kilo C. Combination therapy with insulin glargine plus metformin but not insulin glargine plus sulfonylurea provides similar glycemic control to triple oral combination therapy in patients with type 2 diabetes uncontrolled with dual oral agent therapy. J Diabetes Complications. 2015 Nov-Dec;29(8):1266-71. doi: 10.1016/j.jdiacomp.2015.05.022. Epub 2015 Jun 5. |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| 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 |
| D007267 | Injections |
| D008687 | Metformin |
| D005905 | Glyburide |
| C089946 | 2,4-thiazolidinedione |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| During the study conduct |
| Time to glycemic control | During the study conduct |
| Change in body weight | During the study conduct |
| Change in serum lipid profile | During the study conduct |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D013453 | Sulfonylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |