DUETACT (glimepiride)
DUETACT is a fixed-dose combination of pioglitazone (a thiazolidinedione) and glimepiride (a sulfonylurea) indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. It is used for patients who are already treated with both a thiazolidinedione and a sulfonylurea, or for those who have inadequate glycemic control on either agent alone. DUETACT should not be used for the treatment of type 1 diabetes or diabetic ketoacidosis.
How DUETACT Works
DUETACT combines two antihyperglycemic agents with complementary mechanisms of action. Glimepiride is a sulfonylurea that functions as an insulin secretagogue, stimulating the release of insulin from functioning pancreatic beta cells. Pioglitazone is a thiazolidinedione that acts as a potent and selective agonist for peroxisome proliferator-activated receptor-gamma (PPARγ). Activation of these receptors increases insulin sensitivity in the liver, skeletal muscle, and adipose tissue, leading to increased peripheral glucose disposal and decreased hepatic glucose output. Pioglitazone requires the presence of endogenous insulin to be effective.
Details
- Status
- Prescription
- First Approved
- 2006-07-28
- Patent Cliff
- 2028
- Routes
- ORAL
- Dosage Forms
- TABLET
DUETACT Approval History
What DUETACT Treats
1 indicationsDUETACT is approved for 1 conditions since its original approval in 2006. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Type 2 Diabetes
DUETACT Boxed Warning
CONGESTIVE HEART FAILURE • Thiazolidinediones, including pioglitazone, which is a component of DUETACT ® , cause or exacerbate congestive heart failure in some patients [see Warnings and Precautions ( 5.1 )] . • After initiation of DUETACT 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...
WARNING: CONGESTIVE HEART FAILURE • Thiazolidinediones, including pioglitazone, which is a component of DUETACT ® , cause or exacerbate congestive heart failure in some patients [see Warnings and Precautions ( 5.1 )] . • After initiation of DUETACT 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 DUETACT must be considered [see Warnings and Precautions ( 5.1 )] . • DUETACT is not recommended in patients with symptomatic heart failure [see Warnings and Precautions ( 5.1 )] . • Initiation of DUETACT 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 DUETACT, cause or exacerbate congestive heart failure in some patients. ( 5.1 ) • After initiation of DUETACT, 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 DUETACT must be considered. ( 5.1 ) • DUETACT is not recommended in patients with symptomatic heart failure. ( 5.1 ) • Initiation of DUETACT in patients with established New York Heart Association (NYHA) Class III or IV heart failure is contraindicated. ( 4 , 5.1 )
DUETACT Competitive Set
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Indication competitors
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in DUETACT's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications DUETACT treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to DUETACT
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Clinical Trial Registry
82 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03118713 | 1941-MA-3122-KR | Ph 4 | terminated | A Study to Evaluate the Renal Protective Effect (Urine Albumin-to-Creatinine Ratio (UACR)), Efficacy and Safety of Ipragliflozin in Type 2 Diabetes Mellitus Patients With Albuminuria |
| NCT02956044 results posted | THR-1442-C-453 | Ph 1 | completed | Interaction of Bexagliflozin With Metformin, Glimepiride and Sitagliptin |
| NCT02649465 | CRB4180005 | Ph 4 | completed | SGLT2 Inhibitor Versus Sulfonylurea on Type 2 Diabetes With NAFLD |
| NCT02769481 results posted | THR-1442-C-480 | Ph 3 | completed | Safety and Efficacy of Bexagliflozin Compared to Glimepiride as Add-on Therapy to Metformin in Type 2 Diabetes Subjects |
| NCT03332771 SOTA-GLIM results posted | EFC14838 2016-001801-17, U1111-1190-7596 | Ph 3 | completed | Efficacy and Safety of Sotagliflozin Versus Glimepiride and Placebo in Participants With Type 2 Diabetes Mellitus That Are Taking Metformin Monotherapy |
| NCT02973477 results posted | HUM00121107 | Ph 4 | completed | Dapagliflozin and Measures of Cardiovascular Autonomic Function in Patients With Type 2 Diabetes (T2D) |
| NCT02419612 results posted | CV181-365 | Ph 3 | completed | A 52-week International, Multicenter Trial With a Long -Term Extension to Evaluate Saxagliptin With Dapagliflozin in Combination With Metformin Compared to Glimepiride in Combination With Metformin in Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone |
| NCT02694263 Can Do | 0527 | Ph 4 | completed | Canagliflozin (Invokana™) vs. Standard Dual Therapy Regimen for T2DM During Ramadan |
| NCT01243424 results posted | 1218.74 2009-013157-15 | Ph 3 | completed | CAROLINA: Cardiovascular Outcome Study of Linagliptin Versus Glimepiride in Patients With Type 2 Diabetes |
| NCT02072096 IMPERIUM results posted | 14842 F3Z-MC-IOQL, 2013-001473-24 | Ph 4 | terminated | A Comparison of Two Treatment Strategies in Older Participants With Type 2 Diabetes Mellitus (T2DM) |
| NCT01644500 AWARD-CHN1 results posted | 11991 H9X-JE-GBCG | Ph 3 | completed | A Study Comparing the Effects and Safety of Dulaglutide With Glimepiride in Type 2 Diabetes Mellitus |
| NCT02564926 BEYOND results posted | D1690L00067 | Ph 4 | completed | Foxiga Korea Local Phase 4 Study |
| NCT02312063 DIET results posted | KEP26-49 | Ph 4 | completed | Dietary Impacts on Glucose-lowering Effects of Sitagliptin in Type 2 Diabetes |
| NCT02471404 results posted | D1689C00014 | Ph 4 | completed | Efficacy and Safety of Dapagliflozin and Dapagliflozin Plus Saxagliptin in Combination With Metformin in Type 2 Diabetes Patients Compared With Sulphonylurea |
| NCT02728453 EMPATROPHY | CRC-KliPha-001 | Ph 4 | terminated | SGLT2 Inhibition and Left Ventricular Mass |
| NCT02373865 results posted | DIA-2-REDESIGN | Ph 4 | terminated | Risk of Nocturnal Hypoglycemia and Arrhythmias With Sitagliptin Versus Glimepiride in Patients With Type 2 Diabetes |
| NCT02630706 results posted | 8835-012 B1521045, MK-8835-012 | Ph 3 | completed | A Study to Evaluate the Efficacy and Safety of Ertugliflozin in Asian Participants With Type 2 Diabetes and Inadequate Glycemic Control on Metformin Monotherapy (MK-8835-012) |
| NCT02985242 | M16-04EMPA-EYE 2016-000825-38 | Ph 4 | terminated | Empagliflozin Reduces Progression of Diabetic Retinopathy in Patients With High Risk of Diabetic Macular Edema |
| NCT02036515 results posted | 8835-006 2013-003697-26, B1521015 | Ph 3 | completed | Safety and Efficacy of Ertugliflozin in the Treatment of Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin and Sitagliptin (MK-8835-006; VERTIS SITA2) |
| NCT02226003 results posted | 8835-017 2014-001049-25, B1521047 | Ph 3 | completed | Efficacy and Safety of Ertugliflozin (MK-8835/PF-04971729) With Sitagliptin in the Treatment of Participants With Type 2 Diabetes Mellitus (T2DM) With Inadequate Glycemic Control on Diet and Exercise (MK-8835-017) |
| NCT01717313 results posted | 3102-011 2012-003626-24 | Ph 3 | completed | A Study to Assess the Safety and Efficacy of Omarigliptin (MK-3102) in Participants With Type 2 Diabetes Mellitus (T2DM) and Inadequate Glycemic Control (MK-3102-011) |
| NCT01755156 results posted | 3102-024 2012-003670-11 | Ph 3 | completed | A Study to Evaluate the Safety, Tolerability, and Efficacy of the Addition of Omarigliptin (MK-3102) to Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Therapy (MK-3102-024) |
| NCT01704261 results posted | 3102-022 2012-002612-10 | Ph 3 | completed | Addition of Omarigliptin (MK-3102) to Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Combination Therapy With Glimepiride and Metformin (MK-3102-022) |
| NCT01863667 results posted | 3102-027 2013-000301-23 | Ph 3 | terminated | A Study to Evaluate the Safety and Efficacy of Omarigliptin (MK-3102) Compared With Glimepiride in Participants With Type 2 Diabetes Mellitus for Whom Metformin is Inappropriate (MK-3102-027) |
| NCT01682759 results posted | 3102-016 MK-3102-016 | Ph 3 | completed | A Study of the Safety and Efficacy of Omarigliptin (MK-3102) Compared With Glimepiride in Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (MK-3102-016) |
| NCT01678820 results posted | 0431D-266 | Ph 3 | terminated | A Study of the Efficacy and Safety of MK-0431D (a Fixed-dose Combination of Sitagliptin and Simvastatin) for the Treatment of Participants With Type 2 Diabetes Mellitus (T2DM) With Inadequate Glycemic Control on Metformin Monotherapy (MK-0431D-266) |
| NCT01709305 results posted | 0431-313 | Ph 4 | completed | A Study of the Safety and Efficacy of Glimepiride, Gliclazide, Repaglinide or Acarbose When Added to Sitagliptin + Metformin Combination Therapy in Chinese Participants With Diabetes (MK-0431-313) |
| NCT01590771 results posted | 0431-253 | Ph 3 | completed | A Study in China Evaluating the Safety and Efficacy of Adding Sitagliptin to Stable Therapy With Sulfonylurea With or Without Metformin in Participants With Type 2 Diabetes Mellitus (T2DM) (MK-0431-253) |
| NCT01177384 results posted | 0431-130 2010_543, CTRI/2011/10/002072 | Ph 3 | completed | Clinical Trial to Evaluate the Safety and Efficacy of the Addition of Sitagliptin in Participants With Type 2 Diabetes Mellitus Receiving Acarbose Monotherapy (MK-0431-130) |
| NCT02280486 SPECIFY | ISSSAXA0014 | Ph 4 | completed | Efficacy and Safety of Saxagliptin VS. Glimepiride in Chinese T2DM Patients Controlled Inadequately With Metformin |
| NCT01958671 results posted | 8835-003 2013-002519-90, B1521022 | Ph 3 | completed | A Study of the Efficacy and Safety of Ertugliflozin Monotherapy in the Treatment of Participants With Type 2 Diabetes Mellitus and Inadequate Glycemic Control Despite Diet and Exercise (MK-8835-003, VERTIS MONO) |
| NCT02484209 DiaFrail | DF-07 | Ph 3 | withdrawn | DiaFrail: A Short Duration Study in Older People ( DIAFRAIL Study) |
| NCT02007278 GLOBE results posted | CLAF237ACO01 | Ph 4 | completed | Glycemic Excursions in Type 2 Diabetic Patients With Vildagliptin and Metformin Versus Vildagliptin and Glimepiride |
| NCT01296412 results posted | 0431-403 | Ph 3 | completed | Comparison of Two Treatment Regimens (Sitagliptin Versus Liraglutide) on Participants Who Failed to Achieve Good Glucose Control on Metformin Alone (MK-0431-403) |
| NCT01189890 results posted | 0431-251 | Ph 3 | completed | Safety and Efficacy of Sitagliptin Compared With Glimepiride in Elderly Participants With Type 2 Diabetes Mellitus (MK-0431-251) |
| NCT00858013 results posted | AJIRB-CRO-08-197 | Ph 4 | completed | Study of the Durability of Glycemic Control With Nateglinide |
| NCT00614120 results posted | NN2211-1796 | Ph 3 | completed | Effect of Liraglutide or Glimepiride Added to Metformin on Blood Glucose Control in Subjects With Type 2 Diabetes |
| NCT00620282 results posted | NN2211-1799 | Ph 3 | completed | The Effect of Liraglutide on Endothelial Function in Subjects With Type 2 Diabetes Mellitus |
| NCT01123980 EasyMix results posted | BIASP-3756 U1111-1114-4112, JapicCTI-101139 | Ph 4 | completed | Comparison of the Blood Sugar Lowering Effect of Biphasic Insulin Aspart 30 and Insulin Glargine Both Combined With Metformin and Glimepiride in Chinese and Japanese Subjects With Type 2 Diabetes New to Insulin Treatment |
| NCT01517373 results posted | B1621002 2011-005206-30 | Ph 2 | completed | Study To Understand Efficacy And Safety Of Investigational Agent (PF-04937319) Compared To Approved Agent (Glimepiride) In Patients With Diabetes On Metformin |
| NCT00968812 results posted | CR016480 28431754DIA3009, 2009-009320-36 | Ph 3 | completed | CANagliflozin Treatment And Trial Analysis-Sulfonylurea (CANTATA-SU) SGLT2 Add-on to Metformin Versus Glimepiride |
| NCT00839527 results posted | 112757 | Ph 3 | completed | A Study to Determine the Safety and Efficacy of Albiglutide in Subjects With Type 2 Diabetes |
| NCT00838903 results posted | 112753 | Ph 3 | completed | Efficacy and Safety of Albiglutide in Treatment of Type 2 Diabetes |
| NCT01262586 | CLAF237A23151 2010-021236-34 | Ph 3 | completed | Vildagliptin Glycemic Profiles Assessment Using a Continuous Glucose Monitoring Device. |
| NCT00562250 | MB102-016 | Ph 1 | completed | Pharmacokinetic Drug Interaction Study With Dapagliflozin and Glimepiride in Healthy Subjects |
| NCT00842556 | MB102-037 | Ph 1 | completed | Pharmacokinetic Drug Interaction Study of Dapagliflozin and Glimepiride or Sitagliptin in Healthy Subjects |
| NCT01167881 results posted | 1245.28 2009-016244-39 | Ph 3 | completed | Efficacy and Safety of Empagliflozin (BI 10773) With Metformin in Patients With Type 2 Diabetes |
| NCT01425580 | EU-nr 2010-022695-31 2010-022695-31 | Ph 2 | completed | Liraglutide and Heart Failure in Type 2 Diabetes |
| NCT01829477 results posted | TAK-875_309 2013-000007-17, U1111-1138-8680 | Ph 3 | terminated | Comparison of TAK-875 to Placebo as an Add-on to Glimepiride in Patients With Type 2 Diabetes |
| NCT01481116 results posted | TAK-875_304 2011-001731-24, U1111-1124-2296 | Ph 3 | terminated | Efficacy and Safety of TAK-875 Compared to Glimepiride When Used With Metformin in Participants With Type 2 Diabetes |
Showing 50 of 82 trials
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Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
DUETACT FDA Label Details
Indications & Usage
FDA Label (PDF)DUETACT is indicated for the treatment of Type 2 Diabetes.
WARNING: CONGESTIVE HEART FAILURE • Thiazolidinediones, including pioglitazone, which is a component of DUETACT ® , cause or exacerbate congestive heart failure in some patients [see Warnings and Precautions ( 5.1 )] . • After initiation of DUETACT and after dose increases, monitor patients carefull...
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Patent Timeline
- • Cliff: 2028
- • 8 active patents
Trial Analysis
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Competitive Landscape
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.