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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1128-8605 | Other Identifier | UTN |
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Primary Objective:
- To evaluate the decrease of Hb A1c ≥ 1% after 6 month treatment in patients with Type 2 Diabetes Mellitus (T2DM) uncontrolled on Oral Antidiabetics (OADs)
Secondary Objectives:
6 months
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Human Insulin | Experimental | Dosage of human insulin (Insuman Basal/Comb/Rapid) will be individually adjusted in accordance with the Summary of Product Characteristics (SmPC). Patients will follow the titration algorithm recommended by the physician. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin human (HR1799) | Drug | Pharmaceutical form: solution for injection Route of administration: subcutaneous |
|
| Measure | Description | Time Frame |
|---|---|---|
| Decrease of Hb A1c ≥ 1% | Baseline, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with Hb A1c < 7.5% | 6 months | |
| Rate of hypoglycaemias (symptomatic, severe) | 6 months | |
| Middle dose of insulin per product (Insuman Basal, Insuman Comb, Insuman Rapid) |
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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 |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis Administrative Office | Kyiv | Ukraine |
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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 |
|---|---|
| D007328 | Insulin |
| ID | Term |
|---|---|
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| 6 months |
| Change in FPG | Baseline 6 months |
| Number of patients with adverse events | 6 months |
| Assessment of efficacy of education courses in Diabetes Schools | Percentage of correct answers after second test compare to the testing of the initial level | Baseline, 6 months |
| D004700 | Endocrine System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |