NDAORALTABLET
Approved
Jul 2006
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
37
Data completeness
5/8 — Partial
DUETACT (pioglitazone and glimepiride) by Takeda. Approved for sulfonylurea [epc]. First approved in 2006.
Drug data last refreshed 20h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DUETACT is a fixed-dose oral tablet combining pioglitazone (thiazolidinedione) and glimepiride (sulfonylurea) for the treatment of type 2 diabetes mellitus. It works through dual mechanism: pioglitazone improves insulin sensitivity in muscle and fat tissue, while glimepiride stimulates pancreatic beta cells to increase insulin secretion. This combination addresses both insulin resistance and beta-cell dysfunction in diabetic patients.
LOE Approaching2.1 years to LOE
With 2.1 years to LOE, the DUETACT team faces contraction; focus shifts from growth to managed decline and generic transition planning.
Mechanism of Action
Pharmacologic Class:
Sulfonylurea
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (37)
A Study to Determine the Bioequivalence of Alogliptin and Pioglitazone When Administered as Individual Tablets and as Fixed-Dose Combination (FDC)-SYR-322-4833 BL Tablets to Healthy Russian Participants
Started May 2018
72 enrolled
Healthy Volunteers
Effect of Alogliptin/Pioglitazone on the Preservation of Long-term Beta-cell Function
Started Jul 2017
96 enrolled
Diabetes
Non-Interventional Study of the Use of Alogliptin and Alogliptin Fixed-Dose Combinations With Pioglitazone and With Metformin in Standard Clinical Practice
Started Dec 2016
593 enrolled
Diabetes Mellitus, Type 2
An Extension Study of PEAK Trial
Started May 2016
41 enrolled
Diabetes Mellitus, Type 2
Alogliptin/Pioglitazone (Liovel) Combination Tablets Survey on Long-term Use in Patients With Type 2 Diabetes Mellitus
Started Nov 2011
3,281 enrolled
Type 2 Diabetes Mellitus
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.