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Pioglitazone and Glimepiride
Pioglitazone and glimepiride work together to improve glycemic control by reducing insulin resistance and stimulating insulin release.
Pioglitazone and Glimepiride, marketed by Takeda, is a combination therapy for glycemic control in Type 2 diabetes. The drug's key strength lies in its dual mechanism of action, which reduces insulin resistance and stimulates insulin release, providing comprehensive glycemic management. The primary risk is the key composition patent expiry in 2028, which could lead to increased competition from generics.
At a glance
| Generic name | Pioglitazone and Glimepiride |
|---|---|
| Also known as | ACTOS®, Actos - pioglitazone, Amaryl - glimepiride |
| Sponsor | Takeda |
| Drug class | Sulfonylurea [EPC] |
| Target | PPARγ, ATP-sensitive potassium channel |
| Modality | Small molecule |
| Phase | FDA-approved |
Mechanism of action
Pioglitazone, a thiazolidinedione, reduces insulin resistance in the body's tissues, making them more responsive to insulin. Glimepiride, a sulfonylurea, stimulates the pancreas to release more insulin, helping to lower blood glucose levels.
Approved indications
- Glycemic Control in Type 2 Diabetes
- Combination Therapy for Glycemic Control
Boxed warnings
- WARNING: CONGESTIVE HEART FAILURE Thiazolidinediones, including pioglitazone, which is a component of pioglitazone and glimepiride tablets, cause or exacerbate congestive heart failure in some patients [see Warnings and Precautions (5.1) ] . After initiation of pioglitazone and glimepiride tablets and after dose increases, monitor patients carefully for signs and symptoms of heart failure (e.g., excessive, rapid weight gain, dyspnea, and/or edema). If heart failure develops, it should be managed according to current standards of care and discontinuation or dose reduction of pioglitazone and glimepiride tablets must be considered [see Warnings and Precautions (5.1) ] . Pioglitazone and glimepiride tablets are not recommended in patients with symptomatic heart failure [see Warnings and Precautions (5.1) ] . Initiation of pioglitazone and glimepiride tablets in patients with established New York Heart Association (NYHA) Class III or IV heart failure is contraindicated [see Contraindications (4) and Warnings and Precautions (5.1) ] . WARNING: CONGESTIVE HEART FAILURE See full prescribing information for complete boxed warning. Thiazolidinediones, including pioglitazone, which is a component of pioglitazone and glimepiride tablets, cause or exacerbate congestive heart failure in some patients. ( 5.1 ) After initiation of pioglitazone and glimepiride tablets, and after dose increases, monitor patients carefully for signs and symptoms of heart failure (e.g., excessive, rapid weight gain, dyspnea, and/or edema). If heart failure develops, it should be managed according to current standards of care and discontinuation or dose reduction of pioglitazone and glimepiride tablets must be considered. ( 5.1 ) Pioglitazone and glimepiride tablets are not recommended in patients with symptomatic heart failure. ( 5.1 ) Initiation of pioglitazone and glimepiride tablets in patients with established New York Heart Association (NYHA) Class III or IV heart failure is contraindicated. ( 4 , 5.1 )
Common side effects
- upper respiratory tract infection
- accidental injury
- combined edema/peripheral edema
- hypoglycemia
- upper respiratory tract infection
- weight increased
- edema lower limb
- headache
- urinary tract infection
- diarrhea
- nausea
- pain in limb
Drug interactions
- gemfibrozil (strong CYP2C8 inhibitors)
- rifampin (CYP2C8 inducers)
- topiramate
- medications affecting glucose metabolism
- miconazole (oral)
- CYP2C9 inhibitors/inducers
- colesevelam
Key clinical trials
- Comparative Effectiveness and Safety of Four Second Line Pharmacological Strategies in Type 2 Diabetes Study
- A Study for Comparison of Canagliflozin Versus Alternative Antihyperglycemic Treatments on Risk of Heart Failure Hospitalization and Amputation for Participants With Type 2 Diabetes Mellitus and the Subpopulation With Established Cardiovascular Disease
- Real-World Evaluation of Omarigliptin for Type 2 Diabetes Meliitus in Bangladesh (PHASE4)
- Glimepiride, Alogliptin and Alogliptin+Pioglitazone Combination (PHASE4)
- Canagliflozin (Invokana™) vs. Standard Dual Therapy Regimen for T2DM During Ramadan (PHASE4)
- A Comparison of Two Treatment Strategies in Older Participants With Type 2 Diabetes Mellitus (T2DM) (PHASE4)
- Omarigliptin (MK-3102) Clinical Trial - Add-on to Oral Antihyperglycemic Agent Study in Japanese Participants With Type 2 Diabetes Mellitus (MK-3102-015) (PHASE3)
- A Study to Evaluate the Safety and Efficacy of Sitagliptin 100 mg in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control (MK-0431-229) (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Pioglitazone and Glimepiride CI brief — competitive landscape report
- Pioglitazone and Glimepiride updates RSS · CI watch RSS
- Takeda portfolio CI