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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1116-9956 | Other Identifier | UTN |
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Primary Objective:
Secondary Objective:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm Glimepiride+metformin | Experimental | Start and titration based on FBG and tolerance. Titration should be achieved within maximum 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLIMEPIRIDE + METFORMIN | Drug | Pharmaceutical form: Tablet Route of administration: oral Dose regimen : fixed dose combination of glimepiride / metformin: 1/250, 2/500 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Glycolysated Haemoglobin (HbA1c) | From baseline to Month 4 | |
| Patients With Glycosylated Haemoglobin (HbA1c) Value < 7% | Month 4 | |
| Evolution of Fasting Plasma Glucose (FPG) | From baseline to Months 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Post Prandial Plasma Glucose (PPPG) | Month 4 | |
| Number of patients for each start dose | At baseline | |
| Number of patients with different final doses |
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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 | Almaty | Kazakhstan |
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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 |
|---|---|
| C057619 | glimepiride |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| Month 4 |
| Rate of Symptomatic Hypoglycemia | During treatment period (4 months) |
| Change in Weight | Month 4 |
| D004700 | Endocrine System Diseases |