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The purpose of the study is to compare the effect in blood sugar control between Lantus and twice daily intermediate acting insulins (NPH or Lente) when used as the basal insulin in a multiple daily injection setting with fast acting insulin (Lispro)
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lantus (insulin glargine [rDNA origin] injection) | Drug | |||
| Humulin N | Drug | |||
| Humulin L | Drug | |||
| Lispro | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| to measure change in glycemic control as measured by hemoglobin A1c (A1c). | from baseline to endpoint (last available post-treatment assessment) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in A1c | from baseline to individual study time points | |
| Percentage of subjects achieving an A1c ≤7.0; percent of preteens (12 years and below) achieving 8%; teens (13-18 years) achieving 7.5% | During the study conduct |
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Inclusion 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 |
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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 |
| D000068880 | Isophane Insulin, Human |
| C484564 | insulin, long-acting, human |
| D061268 | Insulin Lispro |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Change in fasting self-monitored blood glucose (SMBG) for weekdays, weekends and weekday/weekend combined | from baseline to endpoint |
| Change in urinary spot random microalbumin-to-creatinine (A/C) ratio | from baseline to endpoint |
| Change in 8-point blood glucose profiles for weekdays, weekends, and weekday/weekend combined | from baseline to endpoint |
| Change in average basal insulin doses | from baseline to endpoint |
| Change in lipids (total cholesterol [TC], high-density lipoprotein cholesterol [HDL], low-density lipoprotein cholesterol [LDL], and triglycerides [TGs]) | from baseline to endpoint |
| Change in glucose | from baseline to endpoint |
| Occurrence of hypoglycemia | from the informed consent signature to the end of the study |
| Adverse events (AEs) | from the informed consent signature to the end of the study |
| Clinical values: physical examination, vital signs, change in age-adjusted body mass index (BMI) | from the informed consent signature to the end of the study |
| 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 |
| D007336 | Insulin, Isophane |
| D061386 | Insulin, Regular, Human |
| D007328 | Insulin |
| D011384 | Proinsulin |
| D061266 | Insulin, Short-Acting |