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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1172-1002 | Other Identifier | UTN |
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Primary Objective:
-To assess the change in glycosylated hemoglobin (HbA1c) in uncontrolled Type 2 diabetes patients on OAD agent in Jordan after 6 months of treatment with basal insulin (Insulin glargine).
Secondary Objectives:
The total duration of study period per patient is up to 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HOE901 | Experimental | HOE901 administered subcutaneously once a day in the evening, at dinner, or at bedtime with titration based on FPG levels |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INSULIN GLARGINE | Drug | Pharmaceutical form:Solution Route of administration: Subcutaneous |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in HbA1c | Baseline, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| - Percentage of patients achieving target of HbA1c <7% | 6 months | |
| - Change from baseline in fasting plasma glucose values | Baseline, 3 months, and 6 months | |
| - Percentage of patients with hypoglycemic events |
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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 |
|---|---|---|---|---|---|---|
| JORDAN | Jordan | Jordan |
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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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| Baseline, 6 months |
| - Change from baseline in body weight | Baseline, 3 months and 6 months |
| - Number of patients with adverse events | Baseline, 6 months |
| - Change in dose of insulin glargine | 3 months and 6 months |
| - Change in the titration doses used (if any) | 6 months |
| - Time to reach control | 6 months |
| D004700 | Endocrine System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |