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Also known as Glimepiride (HOE490), 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...
The glimepiride and metformin combination is used to treat type 2 diabetes mellitus, including non-insulin-dependent diabetes mellitus. It is studied in patients whose blood glucose is inadequately controlled, including those not controlled on metformin alone, and in newly diagnosed type 2 diabetes patients.
The combination targets KCNJ11 and ABCC8, subunits of the ATP-sensitive potassium channel. Both agents act as blockers at this target class. Glimepiride and metformin are small molecules, and the combination is given as a fixed-dose oral product for type 2 diabetes.
Sanofi develops the glimepiride and metformin combination. Sanofi trades under the ticker SNY. The fixed-dose combination is also referred to as Amaryl M and by the code HOE4900.
The glimepiride and metformin combination is in Phase 3 development for type 2 diabetes mellitus. Five Phase 3 trials have been completed, with no active trials currently listed. It is an investigational fixed-dose combination and is not described here as FDA approved.
Completed Phase 3 trials include NCT01699932 in inadequately controlled type 2 diabetes, NCT01459809 comparing the combination with each compound alone in newly diagnosed patients, NCT01457911 in Chinese patients inadequately controlled on metformin, and NCT00924573 in Japan. Total enrollment across the program is 1,238 patients.
Yes. The glimepiride and metformin combination is also known as Amaryl M, HOE4900, and HOE490. Other names used for the same asset include the glimepiride and metformin hydrochloride combination, glimepiride plus metformin, and glimepiride alone, so searches for these terms refer to the same Sanofi program.