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Alogliptin and pioglitazone
At a glance
| Generic name | Alogliptin and pioglitazone |
|---|---|
| Also known as | SYR-322, Actos, SYR110322, Alogliptin, AD-4833 |
| Sponsor | Takeda |
| Modality | Small molecule |
| Phase | FDA-approved |
Approved indications
Boxed warnings
- WARNING: CONGESTIVE HEART FAILURE Thiazolidinediones, including pioglitazone, which is a component of OSENI ® , cause or exacerbate congestive heart failure in some patients [see Warnings and Precautions (5.1) ] . After initiation of OSENI 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 congestive heart failure develops while taking OSENI, consider discontinuation of OSENI or dosage reduction of pioglitazone in OSENI [see Warnings and Precautions (5.1) ] . OSENI is not recommended in patients with symptomatic heart failure [see Warnings and Precautions (5.1) ] . Initiation of OSENI 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 OSENI, cause or exacerbate congestive heart failure in some patients. ( 5.1 ) After initiation of OSENI 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 congestive heart failure develops while taking OSENI, consider discontinuation of OSENI or dosage reduction of pioglitazone in OSENI. ( 5.1 ) OSENI is not recommended in patients with symptomatic heart failure. ( 5.1 ) Initiation of OSENI in patients with established New York Heart Association (NYHA) Class III or IV heart failure is contraindicated. ( 4 , 5.1 )
Common side effects
- Nasopharyngitis
- Back pain
- Upper respiratory tract infection
- Influenza
- Hypoglycemia
Key clinical trials
- The Effect of Alogliptin Combined With Actoplus Met on Glucose and Lipid Metabolism and Pancreatic Function in Patients With T2DM Complicated With MAFLD (PHASE4)
- A Study to Evaluate the Effect of add-on Pioglitazone or Dapagliflozin in Participants With Type 2 Diabetes Mellitus Inadequately Controlled by DPP-4 Inhibitor and Metformin Therapy (PHASE4)
- 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)
- A Double-blind, Parallel Group, Comparative Study of Coadministration AD-4833 and SYR-322 (PHASE4)
- Glimepiride, Alogliptin and Alogliptin+Pioglitazone Combination (PHASE4)
- To Evaluate the Effect of Nesinaact on Non-alcoholic Steatohepatitis Through MRI and Liver Fibroscan in Patients With Type 2 Diabetes (PHASE4)
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:
- Alogliptin and pioglitazone CI brief — competitive landscape report
- Alogliptin and pioglitazone updates RSS · CI watch RSS
- Takeda portfolio CI