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Also known as Glimepiride (HOE490), Glimepiride, glimepiride, GLIMEPIRIDE
Glimepiride and Metformin combination · 6 trials · 3 indications
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | 24-week treatment period: starting dose will be of 2/1000 mg or 4/2000 mg of glimepiride/metformin fixed combination (Amaryl M® ) depending on the previous treatment and dose. The Interventional medicinal product's dose will be increased every 2 weeks up to the maximum tolerated dose of 8/2000 mg of Amaryl M® , 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 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 ≤. |
| AMARYL M (Glimepiride and Metformin hydrochloride combination) | EXPERIMENTAL | AMARYL M at a dosage regimen from 1 tablet to 6 tablets, once during a meal or twice during a meal |
| AMARYL (Glimepiride) | ACTIVE_COMPARATOR | AMARYL at a dosage regimen from 1 mg to 6 mg, once during a meal or twice during a meal |
| 1 | EXPERIMENTAL | Metformin on top of glimepiride Twice a day with 2-6 mg of daily dose for glimepiride and 500-750mg of daily dose for metformin for 24 weeks |
| 2 | PLACEBO_COMPARATOR | Placebo on top of glimepiride Twice a day with 2-6 mg of daily dose for glimepiride and 2-3 tablets of placebo for 24 weeks |
| Name | Type | Description |
|---|---|---|
| Glimepiride+metformin (Amaryl M®) - HOE4900 | DRUG | Pharmaceutical form:tablet Route of administration: oral |
| GLIMEPIRIDE | DRUG | Pharmaceutical form: oral Route of administration: oral |
| METFORMIN | DRUG | Pharmaceutical form: oral Route of administration: oral |
| Glimepiride and Metformin hydrochloride combination (HOE490) | DRUG | Pharmaceutical form:tablet Route of administration: oral |
| Glimepiride (HOE490) | DRUG | Pharmaceutical form:tablet Route of administration: oral |
| placebo | DRUG | oral administration |
Inclusion criteria: * Patients with type 2 diabetes mellitus inadequately controlled despite a treatment with sulfonylurea (SU) alone or metformin alone or a free combination of SU and metformin prior to the study entry. * Signed informed consent, obtained prior any study procedure Exclusion crite...