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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1119-9984 | Other Identifier | UTN |
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Primary Objective:
- To demonstrate the superiority of glimepiride and metformin free combination in comparison to glimepiride or metformin alone in terms of Hb1Ac reduction during a 24-week treatment period in patients with type 2 diabetes mellitus.
Secondary Objectives:
- To assess the effects of the free combination of glimepiride and metformin in comparison to glimepiride or metformin alone on:
The study duration for each patient is approximately 27 weeks with 3 periods: 2-week screening period followed by 24-week treatment period where patient is assigned to one of the three arms according to randomization, and 3 days follow-up period with a last call phone visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARM 1: glimepiride alone | Experimental | 24-week treatment period: After randomization, starting dose will be of 2 mg /day or 1 mg/day of glimepiride if Fasting Plasma Glucose (FPG) at baseline < 180 mg/dL (10 mmol/L) taken once in the morning before breakfast. The treatment's dose will be increased every 2 weeks up to the maximum tolerated dose of 4 mg, and adjusted throughout the 24-week treatment period according to fasting Self Monitored Plasma Glucose (SMPG) values in the objective to obtain fasting SMPG values ≤ 130mg/dL (7.2mmol/L) and > 70 mg/dL (3.9mmol/L) without symptomatic hypoglycemia. |
|
| ARM 2: metformin alone | Experimental | 24-week treatment period: After randomization, starting dose will be of 500 mg of metformin twice a day during or after meals. The treatment's dose will be increased every 2 weeks up to the maximum tolerated dose of 2000 mg, and adjusted throughout the 24-week treatment period according to fasting SMPG values in the objective to obtain fasting SMPG values ≤ 130mg/dL (7.2mmol/L) and > 70 mg/dL (3.9mmol/L) without symptomatic hypoglycemia. |
|
| ARM3: Glimepiride/metformin free combination | Experimental | 24-week treatment period: After randomization, starting dose will be of 2 mg /day or 1 mg/day of glimepiride if FPG at baseline < 180 mg/dL (10 mmol/L) taken once in the morning and 500 mg of metformin twice a day taken during or after meals. The treatment's dose will be increased every 2 weeks up to the maximum tolerated dose of 4 mg of glimepiride and 2000 mg of metformin, and adjusted throughout the 24-week treatment period according to fasting SMPG values in the objective to obtain values ≤. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLIMEPIRIDE | Drug | Pharmaceutical form: oral Route of administration: oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c | from baseline to week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with HbA1c < 7% | at week 24 | |
| Percentage of patients with HbA1c < 6.5 % | at week 24 | |
| Change in Fasting Plasma Glucose (FPG) |
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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 |
|---|---|---|---|---|---|---|
| Investigational Site Number 01206 | Algeries | Algeria | ||||
| Investigational Site Number 01203 |
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| METFORMIN | Drug | Pharmaceutical form: oral Route of administration: oral |
|
| from baseline week 24 |
| Number of patients reporting adverse events | overt the 24-weeks treatment period |
| Frequence and incidence of hypoglycemia | over the 24-weeks treatment period |
| Oran |
| 31000 |
| Algeria |
| Investigational Site Number 01205 | Sétif | 19000 | Algeria |
| Investigational Site Number 17003 | El Espinal | Colombia |
| Investigational Site Number 170001 | Manizales | 170 | Colombia |
| Investigational Site Number 81801 | Cairo | Egypt |
| Investigational Site Number 81802 | Cairo | Egypt |
| Investigational Site Number 81803 | Cairo | Egypt |
| Investigational Site Number 32001 | Guatemala City | Guatemala |
| Investigational Site Number 32002 | Guatemala City | Guatemala |
| Investigational Site Number 32003 | Guatemala City | Guatemala |
| Investigational Site Number 32004 | Guatemala City | Guatemala |
| Investigational Site Number 356001 | Bangalore | 560043 | India |
| Investigational Site Number 356002 | Bangalore | 560052 | India |
| Investigational Site Number 356006 | Ernākulam | India |
| Investigational Site Number 356003 | Indore | 452010 | India |
| Investigational Site Number 356009 | Lucknow | 226003 | India |
| Investigational Site Number 356010 | Mumbai | India |
| Investigational Site Number 356007 | Nashik | 422002 | India |
| Investigational Site Number 356008 | Pune | 411007 | India |
| Investigational Site Number 356005 | Varanasi | India |
| Investigational Site Number 364001 | Tehran | 1411413137 | Iran |
| Investigational Site Number 364002 | Tehran | 1666694516 | Iran |
| Investigational Site Number 36403 | Tehran | Iran |
| Investigational Site Number 42201 | Beirut | Lebanon |
| Investigational Site Number 42202 | Beirut | Lebanon |
| Investigational Site Number 42203 | Chouf | Lebanon |
| Investigational Site Number 422004 | Hazmiyeh | Lebanon |
| Investigational Site Number 484002 | Guadalajara | 44340 | Mexico |
| Investigational Site Number 484003 | Guadalajara | 44670 | Mexico |
| Investigational Site Number 643003 | Moscow | 119002 | Russia |
| Investigational Site Number 643001 | Saint Petersburg | Russia |
| Investigational Site Number 643002 | Saratov | 410012 | Russia |
| Investigational Site Number 710-002 | Durban | 4091 | South Africa |
| Investigational Site Number 710-001 | Durban | 4092 | South Africa |
| Investigational Site Number 78803 | La Marsa | 2070 | Tunisia |
| Investigational Site Number 78804 | La Marsa | 2070 | Tunisia |
| Investigational Site Number 78805 | Sfax | Tunisia |
| Investigational Site Number 78801 | Tunis | Tunisia |
| Investigational Site Number 78802 | Tunis | Tunisia |
| Investigational Site Number 78806 | Tunis | Tunisia |
| Investigational Site Number 78807 | Tunis | Tunisia |
| Investigational Site Number 792-004 | Adana | Turkey (Türkiye) |
| Investigational Site Number 792-003 | Antalya | 07070 | Turkey (Türkiye) |
| Investigational Site Number 792-001 | Istanbul | 34722 | Turkey (Türkiye) |
| Investigational Site Number 792-006 | Istanbul | 34890 | Turkey (Türkiye) |
| Investigational Site Number 792-002 | Kütahya | Turkey (Türkiye) |
| Investigational Site Number 792-005 | Sivas | 58140 | Turkey (Türkiye) |
| Investigational Site Number 804001 | Kyiv | 02175 | Ukraine |
| Investigational Site Number 804002 | Kyiv | 04114 | Ukraine |
| Investigational Site Number 804003 | Zaporizhzhya | Ukraine |
| Investigational Site Number 784-001 | Dubai | United Arab Emirates |
| Investigational Site Number 784-002 | Dubai | United Arab Emirates |
| Investigational Site Number 784-003 | Dubai | United Arab Emirates |
| Investigational Site Number 784-004 | Sharjah city | 46458 | United Arab Emirates |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System 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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