Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
glimepiride · 1 trial · 1 indication
Change from baseline
Change from baseline
| Arm | Type | Description |
|---|---|---|
| Glimepiride Atorvastatin fixed dose combination | ACTIVE_COMPARATOR | All subjects will start on 1mg glimepiride/10 mg atorvastatin fixed dose combination (FDC) and either treatment can be titrated up based on fasting glucose or LDL levels. The following glimepiride/atorvastations FDCs will be available for use 1mg/10mg, 2mg/10mg, 3mg/10mg, 4mg/10mg, 1mg/20mg, 2mg/20mg, 3mg/20mg, 4mg/20mg. |
| Glimepiride +Atrovastatin loose combination | ACTIVE_COMPARATOR | All subjects will start on 1mg glimepiride/10 mg atorvastatin loose combination (given as separate tablets) and either treatment can be titrated up based on fasting glucose or LDL levels. Glimepiride single dose tablets are available for 1mg, 2mg, 3mg and 4mg. Atorvastatin single dose tablets are available for 10mg and 20mg. |
| Name | Type | Description |
|---|---|---|
| 1mg Glimepiride/10mg Atorvastatin FDC | DRUG | 1 tablet by mouth once a day |
| 2mg Glimepiride/10mg Atorvastatin FDC | DRUG | 1 tablet by mouth once a day |
| 3mg Glimepiride/10mg Atorvastatin FDC | DRUG | 1 tablet by mouth once a day |
| 4mg Glimepiride/10mg Atorvastatin FDC | DRUG | 1 tablet by mouth once a day |
| 1mg Glimepiride/20mg Atorvastatin FDC | DRUG | 1 tablet by mouth once a day |
| 2mg Glimepiride/20mg Atorvastatin FDC | DRUG | 1 tablet by mouth once a day |
| 3mg Glimepiride/20mg Atorvastatin FDC | DRUG | 1 tablet by mouth once a day |
| 4mg Glimepiride/20mg Atorvastatin FDC | DRUG | 1 tablet by mouth once a day |
| 1mg Glimepiride | DRUG | 1 tablet of Glimepiride and 1 tablet of Atorvastatin co-administered once daily |
| 2mg Glimepiride | DRUG | 1 tablet of Glimepiride and 1 tablet of Atorvastatin co-administered once daily |
| 3mg Glimepiride | DRUG | 1 tablet of Glimepiride and 1 tablet of Atorvastatin co-administered once daily |
| 4mg Glimepiride | DRUG | 1 tablet of Glimepiride and 1 tablet of Atorvastatin co-administered once daily |
| 10mg Atorvastatin | DRUG | 1 tablet of Atorvastatin and 1 tablet of Glimepiride co-administered once daily |
| 20mg Atorvastatin | DRUG | 1 tablet of Atorvastatin and 1 tablet of Glimepiride co-administered once daily |
Inclusion Criteria: * Adult (≥18 years of age) males and females ( including of child-bearing potential) with Type 2 diabetes mellitus. * Currently treated for Type 2 daibetes mellitus with metformin monotherapy and have been a stable dose of metformin for atleast 3 months * patients with CVD or ≥4...
Glimepiride is used to treat type 2 diabetes mellitus. It is being developed as a fixed-dose combination with atorvastatin, pairing glucose-lowering with lipid management in a single regimen. The combination is in Phase 3 development for adults with type 2 diabetes.
Glimepiride targets KCNJ11 and ABCC8, the subunits of the ATP-sensitive potassium channel on pancreatic beta cells. It acts as a blocker of this channel, which promotes insulin secretion. This target class is the mechanism behind its glucose-lowering effect in type 2 diabetes.
GlaxoSmithKline plc, which trades as GSK on the New York Stock Exchange under the ticker GSK, is the developer of the glimepiride and atorvastatin fixed-dose combination. The company is responsible for the Phase 3 program evaluating this combination in type 2 diabetes.
Glimepiride in combination with atorvastatin is in Phase 3 clinical development. It is an investigational fixed-dose combination and has not been approved by the FDA for the type 2 diabetes indication described here. The program includes one completed Phase 3 trial.
The glimepiride and atorvastatin combination has been studied in one Phase 3 trial, NCT01495013. That trial compared the fixed-dose combination with loose combinations of atorvastatin and glimepiride in patients with type 2 diabetes. It enrolled 427 participants across Malaysia, Mexico, the Philippines, Russia, South Korea, and Thailand, and is completed.