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Details for Generic Name: GLIMEPIRIDE

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Glimepiride is the generic ingredient in five branded drugs marketed by Sanofi Aventis Us, Accord Hlthcare, Actavis Labs Fl Inc, Aurobindo Pharma Ltd, Carlsbad, Corepharma, Dr Reddys Labs Ltd, Hikma Pharms, Indoco Remedies, Invagen Pharms, Micro Labs Ltd India, Mylan, Ranbaxy, Ranbaxy Labs Ltd, Teva, Vintage, Watson Labs, Takeda Pharms Usa, Sandoz, and Sb Pharmco, and is included in twenty-one NDAs. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are fourteen drug master file entries for glimepiride. One supplier is listed for this compound.

Summary for Generic Name: GLIMEPIRIDE

Tradenames:5
Patents:9
Applicants:20
NDAs:21
Drug Master File Entries: see list14
Suppliers: see list1
Therapeutic Class:Blood Glucose Regulators
Formulation / Manufacturing:see details

Pharmacology for Ingredient: GLIMEPIRIDE

Ingredient-typeSulfonylurea Compounds
Drug ClassSulfonylurea

Clinical Trials for: GLIMEPIRIDE

Crossover Study to Evaluate the Comparative Bioavailability of Two Fixed Dose Combination Tablet Formulations of Extended Release Metformin and Extended Release Glimepiride in Health Volunteers
Status: Terminated Condition: Diabetes Mellitus, Type 2

A Comparison of Atorvastatin and Glimepiride Fixed Dose Combination and Atorvastatin and Glimepiride Loose Combination in the Treatment of Patients With Type 2 Diabetes Mellitus
Status: Completed Condition: Diabetes Mellitus, Type 2

Bioequivalence Study of Dr.Reddy's Laboratories Limited, Glimepiride Tablets 1 mg Under Fasting Condition
Status: Completed Condition: Healthy

Bioequivalence Study of 4 mg Glimepiride Tablet
Status: Completed Condition: Glimepiride BE Study in Healthy Volunteers Under Fasting Condition

Bioequivalence Study of Dr.Reddys Laboratories Limited, Glimepiride 1 mg Tablets in Healthy Subjects Under Fed Condition
Status: Completed Condition: Healthy

Efficacy and Safety of Sitagliptin/Metformin Fixed-Dose Combination (FDC) Compared to Glimepiride in Participants With Type 2 Diabetes Mellitus (MK-0431A-202)
Status: Completed Condition: Type 2 Diabetes Mellitus

Safety and Efficacy of Sitagliptin Compared With Glimepiride in Elderly Participants With Type 2 Diabetes Mellitus (MK-0431-251)
Status: Completed Condition: Type 2 Diabetes Mellitus

Risk of Nocturnal Hypoglycemia and Arrhythmias With Sitagliptin Versus Glimepiride in Patients With Type 2 Diabetes
Status: Not yet recruiting Condition: Diabetes Mellitus Type 2

TAK-875 Glimepiride Drug-Interaction Study
Status: Completed Condition: Pharmacokinetics

Effects of Glimepiride on Recovery From Hypoglycemia in Participants With Type 2 Diabetes Mellitus (MK-0000-253)
Status: Completed Condition: Type 2 Diabetes Mellitus

An Efficacy and Safety Study of Fixed-dose Rosiglitazone/Glimepiride to Treat Chinese Type 2 Diabetes Patients
Status: Terminated Condition: Diabetes Mellitus, Type 2

Study of Metabolic and Haemodynamic Effects of Metformin and Glimepiride in Patients With Type 2 Diabetes Mellitus
Status: Completed Condition: Type 2 Diabetes

Efficacy and Safety Comparison of Metformin/Glimepiride Combination Versus Each Compound Alone in New Diagnosed Type 2 Diabetes Patients
Status: Completed Condition: Diabetes Mellitus, Type 2

Effect of Exenatide, Sitagliptin or Glimepiride on Functional ß -Cell Mass
Status: Completed Condition: Pre-diabetes; Type 2 Diabetes

Relative Bioavailability of BI 10773 and Glimepiride in Healthy Male Volunteers
Status: Completed Condition: Healthy

Safety and Efficacy of Saxagliptin vs.Glimepiride as Add-on Therapy in T2DM Patients With Metformin Monotherapytients
Status: Recruiting Condition: Type 2 Diabetes

Pharmacokinetic Drug Interaction Study Between Gemigliptin and Glimepiride in Healthy Male Subjects
Status: Completed Condition: Healthy

A Study of the Safety and Efficacy of MK-3102 Compared With Glimepiride in Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (MK-3102-016)
Status: Completed Condition: Type 2 Diabetes Mellitus

CANagliflozin Treatment And Trial Analysis-Sulfonylurea (CANTATA-SU) SGLT2 Add-on to Metformin Versus Glimepiride
Status: Completed Condition: Diabetes Mellitus, Type 2

To Evaluate the Effect of Liraglutide Versus Glimepiride (Amaryl®) on Haemoglobin A1c
Status: Terminated Condition: Diabetes; Diabetes Mellitus, Type 2

Safety and Efficacy of Glimepiride, Gliclazide, Repaglinide or Acarbose Added to Sitagliptin + Metformin Combination Therapy in Chinese Participants With Diabetes (MK-0431-313)
Status: Active, not recruiting Condition: Type 2 Diabetes Mellitus

Efficacy/Safety Study of Glimepiride to Type 2 Diabetes Patients Based on Metformin And Basal Insulin Treatment
Status: Recruiting Condition: Diabetes Mellitus, Type 2

Exenatide Versus Glimepiride in Patients With Type 2 Diabetes
Status: Completed Condition: Type 2 Diabetes Mellitus

Dose Proportionality Study Comparing Amaryl-M 1/500 mg and Amaryl-M 2/500 mg
Status: Completed Condition: Healthy

A Study to Evaluate the Safety and Efficacy of MK-3102 Compared With Glimepiride in Participants With Type 2 Diabetes Mellitus for Whom Metformin is Inappropriate (MK-3102-027)
Status: Terminated Condition: Type 2 Diabetes Mellitus

Pharmacokinetic Drug Interaction Study With Dapagliflozin and Glimepiride in Healthy Subjects
Status: Completed Condition: Diabetes Mellitus, Type 2

ADIponectin and Asymmetric Dimethylarginine (ADMA) Level in Type-2 Diabetes Patients After 12 Weeks of Treatment With GlimepiRide And Metformin Fixed Dose Combination
Status: Completed Condition: Diabetes Mellitus, Type 2

Drug-drug Interaction Study With ASP1941 and Glimepiride
Status: Completed Condition: Healthy Subjects

Ranolazine When Added to Glimepiride in Subjects With Type 2 Diabetes Mellitus
Status: Completed Condition: Type 2 Diabetes Mellitus

Study of the Durability of Glycemic Control With Nateglinide
Status: Recruiting Condition: Type 2 Diabetes Mellitus

The Pharmacokinetic Interaction Between CKD-501 and Sulfonylurea
Status: Completed Condition: Healthy Male Volunteer

Efficacy and Safety of Vildagliptin in Combination With Glimepiride in Patients With Type 2 Diabetes
Status: Completed Condition: Diabetes Mellitus, Type 2

Efficacy Study of Pioglitazone and Glimepiride on the Rate of Progression of Atherosclerotic Disease.
Status: Completed Condition: Diabetes Mellitus

Comparative Study of HOE490 O (Glimepiride and Metformin) Compared With Placebo on Top of Glimepiride
Status: Completed Condition: Type 2 Diabetes Mellitus

Ertugliflozin vs. Glimepiride in Type 2 Diabetes Mellitus (T2DM) Participants on Metformin (MK-8835-002)
Status: Active, not recruiting Condition: Type 2 Diabetes Mellitus

Glycemic Excursions in Type 2 Diabetic Patients With Vildagliptin and Metformin Versus Vildagliptin and Glimepiride
Status: Recruiting Condition: Type 2 Diabetes; Hypoglycemia

Comparison of TAK-875 to Placebo as an Add-on to Glimepiride in Patients With Type 2 Diabetes
Status: Terminated Condition: Diabetes Mellitus, Type 2

CAROLINA: Cardiovascular Outcome Study of Linagliptin Versus Glimepiride in Patients With Type 2 Diabetes
Status: Active, not recruiting Condition: Diabetes Mellitus, Type 2

Efficacy of Pioglitazone and Glimepiride Combination Therapy in Treating Subjects With Type 2 Diabetes Mellitus.
Status: Completed Condition: Diabetes Mellitus

Glimepiride 4 mg Tablets Under Fasting Conditions
Status: Completed Condition: Healthy

Glimepiride 4 mg Tablets Under Non-Fasting Conditions
Status: Completed Condition: Healthy

A Long-term Trial to Compare the Effects of Liraglutide and Sulphonylurea (Glimepiride) Both in Combination With Metformin on Clinical, Endothelial and Image Markers of Cardiovascular Risk in Patients With Type 2 Diabetes
Status: Withdrawn Condition: Type 2 Diabetes

24-Hour Glycemia: Rosiglitazone Versus Glimepiride In Type 2 Diabetes
Status: Completed Condition: Non-Insulin-Dependent Diabetes Mellitus

Efficacy and Safety of Dapagliflozin in Combination With Glimepiride (a Sulphonylurea) in Type 2 Diabetes Patients
Status: Completed Condition: Type 2 Diabetes

A Study to Evaluate ITCA 650 Compared to Glimepiride for the Treatment of Type 2 Diabetes
Status: Withdrawn Condition: Type 2 Diabetes

Evaluation of Fixed Dose Combination of Glimepiride and Metformin in Chinese Type 2 Diabetes Patients Inadequately Controlled With Metformin
Status: Completed Condition: Type 2 Diabetes Mellitus

Comparison of Vildagliptin vs. Glimepiride on Glucose Variability in Metformin Uncontrolled Type 2 Diabetic Patients
Status: Recruiting Condition: Type 2 Diabetes Mellitus

Effect of Linagliptin in Comparison With Glimepiride as Add on to Metformin on Postprandial Beta Cell Function, Postprandial Metabolism and Oxidative Stress in Patients With Type 2 Diabetes Mellitus
Status: Recruiting Condition: Diabetes Mellitus Type 2

A Study Comparing the Effects and Safety of Dulaglutide With Glimepiride in Type 2 Diabetes Mellitus
Status: Completed Condition: Type 2 Diabetes Mellitus

Pharmacokinetic Drug Interaction Study of Dapagliflozin and Glimepiride or Sitagliptin in Healthy Subjects
Status: Completed Condition: Type 2 Diabetes Mellitus

Efficacy and Safety of Glimepiride as Oral Anti-Diabetic (OAD) Initiation Mono-therapy in Chinese Type 2 Diabetes Mellitus (T2DM)
Status: Completed Condition: Diabetes Mellitus, Type 2

Efficacy/Safety Study of Amaryl®M 1/500 mg Twice Daily Versus Amaryl® 4 mg Both in Combination With Lantus® in Type 2 Diabetes Mellitus
Status: Completed Condition: Type 2 Diabetes Mellitus

Bioequivalence Study of Glimepiride 1mg Tablets Under Fed Conditions
Status: Completed Condition: Healthy

Bioequivalence Study of Glimepiride 1mg Tablets Under Fasting Conditions
Status: Completed Condition: Healthy

Impact of Sitagliptin on Cardiovascular Exercise Performance in Type 2 Diabetes
Status: Recruiting Condition: Type 2 Diabetes; Cardiovascular Disease

Glimepiride Induced Insulin Secretion Will be Inhibited by Hypoglycemia
Status: Completed Condition: Type 2 Diabetes

Dose Proportionality Study About Amaryl M Slow Release (SR) 1/500 mg
Status: Completed Condition: Healthy

Endothelial Disfunction Treatment With Glimepiride/Metformin Combination (Glimetal) in Type 2 Diabetes Patients
Status: Completed Condition: Endothelial Dysfunction; Diabetes Mellitus

Trial to Assess the Influence of 4 Weeks' Treatment With Linagliptin as Compared to Glimepiride and Placebo on Endothelial Function in Patients With Type 2 Diabetes Using FMD (Flow-Mediated Vasodilation)
Status: Completed Condition: Diabetes Mellitus, Type 2

Effect of Liraglutide or Glimepiride Added to Metformin on Blood Glucose Control in Subjects With Type 2 Diabetes
Status: Completed Condition: Diabetes; Diabetes Mellitus, Type 2

BIOAVAILABILITY OF Glimepiride/Extended Release Metformin (GLI/METXR): High Fat Diet Study
Status: Completed Condition: Healthy

Saxagliptin Compared to Glimepiride in Elderly Type 2 Diabetes Patients, With Inadequate Glycemic Control on Metformin
Status: Completed Condition: Type 2 Diabetes Mellitus

Efficacy and Safety of TAK-875 Compared to Glimepiride When Used With Metformin in Participants With Type 2 Diabetes
Status: Terminated Condition: Diabetes Mellitus, Type 2

Superiority of Glimepiride Over Sitagliptin in Naive Type 2 Diabetes Patients
Status: Completed Condition: Diabetes Mellitus, Type 2

Addition of MK-3102 to Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Combination Therapy With Glimepiride and Metformin (MK-3102-022)
Status: Completed Condition: Type 2 Diabetes Mellitus

Effect of Oral Combination Therapy in a Single Dosage Form in Patients With Type 2 Diabetes Mellitus
Status: Completed Condition: Type 2 Diabetes Mellitus

A Study to Evaluate ITCA 650 Compared to Glimepiride as Add on Therapy for the Treatment of Type 2 Diabetes
Status: Withdrawn Condition: Type 2 Diabetes

To Compare the Effect of Liraglutide When Given Together With Metformin With the Effect of Metformin Given Alone and With the Effect of Glimepiride and Metformin Given Together
Status: Completed Condition: Diabetes; Diabetes Mellitus, Type 2

Avandia™ + Amaryl™ or Avandamet™ Compared With Metformin (AVALANCHE™ Study)
Status: Completed Condition: Type 2 Diabetes Mellitus

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 Without Control on Metformin Alone
Status: Not yet recruiting Condition: Diabetes

Phase III Trial to Evaluate the Efficacy and Safety of Gemigliptin 50mg qd Added to Ongoing Glimepiride as Fix-dose Combination in Patients With Type 2 Diabetes
Status: Not yet recruiting Condition: Type 2 Diabetes Mellitus

A Study to Test the Safety and Efficacy of Sitagliptin Compared to Glimepiride in Patients With Type 2 Diabetes on a Stable Dose of Metformin (0431-803)(COMPLETED)
Status: Completed Condition: Type 2 Diabetes Mellitus, Non Insulin Dependent.; Diabetes Mellitus, Non-Insulin-Dependent

Study To Understand Efficacy And Safety Of Investigational Agent (PF-04937319) Compared To Approved Agent (Glimepiride) In Patients With Diabetes On Metformin
Status: Completed Condition: Diabetes Mellitus, Type 2

Vildagliptin Glycemic Profiles Assessment Using a Continuous Glucose Monitoring Device.
Status: Completed Condition: Type II Diabetes Mellitus

Efficacy Study of Pioglitazone Compared to Glimepiride on Coronary Atherosclerotic Disease Progression in Subjects With Type 2 Diabetes Mellitus
Status: Completed Condition: Diabetes Mellitus

COMPOUND (INN): HOE490O - GLIMEPIRIDE / METFORMIN HCl (Amaryl® M)0 (Glimepiride/Metformin Hydrochloride Immediate Release Combination Tablet) in Fed Conditions in Healthy Male and/or Female Subjects.
Status: Not yet recruiting Condition: Healthy

Vildagliptin Compared to Glimepiride in Combination With Metformin in Patients With Type 2 Diabetes
Status: Completed Condition: Diabetes Mellitus, Type 2

A Randomised, db, Placebo-controlled Study of BI 1356 for 18 Weeks Followed by a 34 Week Double-blind Extension Period (Placebo Patients Switched to Glimepiride) in Type 2 Diabetic Patients for Whom Treatment With Metformin is Inappropriate
Status: Completed Condition: Diabetes Mellitus, Type 2

A Study of the Co-administration of Sitagliptin and Atorvastatin in Inadequately Controlled Type 2 Diabetes Mellitus (MK-0431E-211)
Status: Terminated Condition: Type 2 Diabetes Mellitus

Food Study of Glimepiride Tablets 1 mg to Amaryl® Tablets 1 mg
Status: Completed Condition: Healthy

Fasting Study of Glimepiride Tablets 1 mg to Amaryl® Tablets 1 mg
Status: Completed Condition: Healthy

Effects of Gemigliptin Versus Sitagliptin or Glimepiride With Metformin on Glucose Variability(MAGE, Glucose SD) Patients With Type 2 DM(STABLE Study)
Status: Completed Condition: Type 2 Diabetes Mellitus

START-J: SiTAgliptin in eldeRly Trial in Japan
Status: Completed Condition: Type 2 Diabetes

Compare the Compliance of Patients Treated With Once-daily (od) or Twice-daily (Bid) Glimepiride and Metformin Fixed Combination Therapy
Status: Completed Condition: Type 2 Diabetes Mellitus

Efficacy of Pioglitazone/Metformin Combination Therapy in Subjects With Type 2 Diabetes Mellitus and Dyslipidemia.
Status: Completed Condition: Diabetes Mellitus; Dyslipidemias

Initiation and Titration of Amaryl
Status: Completed Condition: Diabetes Mellitus, Type 2

Effects of Vildagliptine and Glimepiride on Glucose Variability
Status: Recruiting Condition: Diabetes Mellitus, Non-Insulin-Dependent

Study Comparing Efficacy and Safety of Amaryl M and Metformin Uptitraion to Type 2 DM
Status: Completed Condition: Type 2 Diabetes Mellitus

Efficacy and Safety of Albiglutide in Treatment of Type 2 Diabetes
Status: Completed Condition: Diabetes Mellitus, Type 2

Glimepiride vs Metformin as Monotherapy in Pediatric Subjects With Type 2 Diabetes Mellitus
Status: Completed Condition: Type 2 Diabetes Mellitus

Pioglitazone/Glimepiride (Sonias) Combination Tablets Special Drug Use Surveillance Survey in Patients With Type 2 Diabetes Mellitus Who Respond Poorly to Pioglitazone
Status: Completed Condition: Type 2 Diabetes

Efficacy and Safety of the Fixed Dose Combination of Glimepiride+Metformin in Type 2 Diabetic Patients Inadequately Controlled
Status: Completed Condition: Type 2 Diabetes Mellitus

Effects of Sitaglpitin on Endothelial Function During the OGTT in T2DM
Status: Not yet recruiting Condition: Type 2 Diabetes

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
Status: Completed Condition: Diabetes; Diabetes Mellitus, Type 2

Efficacy and Safety of BI 1356 BS (Linagliptin) in Combination With Metformin in Patients With type2 Diabetes
Status: Completed Condition: Diabetes Mellitus, Type 2

Safety and Efficacy of Linagliptin in Type-2-diabetes Mellitus Patients With Moderate to Severe Renal Impairment
Status: Completed Condition: Diabetes Mellitus, Type 2

Efficacy and Safety of BI 1356 in Combination With Metformin in Patients With Type 2 Diabetes
Status: Completed Condition: Diabetes Mellitus, Type 2

Efficacy and Safety of Alogliptin Used in Combination With Sulfonylurea in Participants With Type 2 Diabetes in Japan
Status: Completed Condition: Type 2 Diabetes Mellitus

A Study to Determine the Safety and Efficacy of Albiglutide in Subjects With Type 2 Diabetes
Status: Completed Condition: Diabetes Mellitus, Type 2

The Effects of GLP-1 in Maturity-Onset Diabetes of The Young (MODY)
Status: Completed Condition: Maturity-onset Diabetes of the Young

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Watson Labs
GLIMEPIRIDE
glimepiride
TABLET;ORAL077280-003Feb 3, 2006DISCNNo<disabled><disabled>
Corepharma
GLIMEPIRIDE
glimepiride
TABLET;ORAL077274-002Oct 6, 2005DISCNNo<disabled><disabled>
Carlsbad
GLIMEPIRIDE
glimepiride
TABLET;ORAL077911-002Sep 22, 2009RXNo<disabled><disabled>
Vintage
GLIMEPIRIDE
glimepiride
TABLET;ORAL077370-004Dec 23, 2005RXNo<disabled><disabled>
Vintage
GLIMEPIRIDE
glimepiride
TABLET;ORAL077370-003Dec 23, 2005RXNo<disabled><disabled>
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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