Data updated: May 26, 2026
ROSIGLITAZONE MALEATE AND GLIMEPIRIDE (glimepiride)
Metabolic
Approved 2016-04-01
1
Indication
--
Phase 3 Trials
10
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2016-04-01
- Routes
- ORAL
- Dosage Forms
- TABLET
ROSIGLITAZONE MALEATE AND GLIMEPIRIDE Approval History
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
5 FDA actions from 2016 to 2016
What ROSIGLITAZONE MALEATE AND GLIMEPIRIDE Treats
1 FDA approvalsOriginally approved for its first indication in 2016 .
- Other (1)
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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
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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.
ROSIGLITAZONE MALEATE AND GLIMEPIRIDE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.