JENTADUETO (linagliptin)
Jentadueto is a fixed-dose combination of linagliptin (a DPP-4 inhibitor) and metformin hydrochloride (a biguanide) indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. It is not recommended for use in patients with type 1 diabetes. Additionally, Jentadueto has not been studied in patients with a history of pancreatitis; therefore, it is unknown if these patients are at an increased risk for developing pancreatitis while using this medication.
How JENTADUETO Works
Jentadueto combines two antihyperglycemic agents with complementary mechanisms of action. Linagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor that slows the degradation of incretin hormones (GLP-1 and GIP). This increases active incretin levels, stimulating glucose-dependent insulin secretion and reducing glucagon circulation. Metformin is a biguanide that improves glucose tolerance by decreasing hepatic glucose production, decreasing intestinal absorption of glucose, and improving insulin sensitivity by increasing peripheral glucose uptake and utilization.
Details
- Status
- Prescription
- First Approved
- 2012-01-30
- Patent Cliff
- 2037
- Routes
- ORAL
- Dosage Forms
- TABLET
JENTADUETO Approval History
What JENTADUETO Treats
1 indicationsJENTADUETO is approved for 1 conditions since its original approval in 2012. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Type 2 Diabetes
JENTADUETO Boxed Warning
LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Metformin-associated lactic acidosis was characterized by elevated blood lactate levels (>5 mmol/Liter), anion gap acidosis (without evidence of ketonuri...
WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Metformin-associated lactic acidosis was characterized by elevated blood lactate levels (>5 mmol/Liter), anion gap acidosis (without evidence of ketonuria or ketonemia), an increased lactate/pyruvate ratio; and metformin plasma levels generally >5 mcg/mL [see Warnings and Precautions (5.1) ]. Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (e.g., carbonic anhydrase inhibitors such as topiramate), age 65 years old or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (e.g., acute congestive heart failure), excessive alcohol intake, and hepatic impairment. Steps to reduce the risk of and manage metformin-associated lactic acidosis in these high risk groups are provided in the full prescribing information [see Dosage and Administration (2.2) , Contraindications (4) , Warnings and Precautions (5.1) , Drug Interactions (7) , and Use in Specific Populations (8.6 , 8.7) ]. If metformin-associated lactic acidosis is suspected, immediately discontinue JENTADUETO and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended [see Warnings and Precautions (5.1) ]. WARNING: LACTIC ACIDOSIS See full prescribing information for complete boxed warning. Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. Symptoms included malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Laboratory abnormalities included elevated blood lactate levels, anion gap acidosis, increased lactate/pyru
JENTADUETO Target & Pathway
ProTarget
A hormone released after eating that stimulates insulin secretion, suppresses glucagon, slows gastric emptying, and promotes satiety. GLP-1 receptor agonists mimic these effects, improving blood sugar control and promoting weight loss in diabetes and obesity.
JENTADUETO Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
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 JENTADUETO's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications JENTADUETO treats. First-in-class if their pivotal trials read out positive.
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Clinical Trial Registry
68 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03337698 Morpheus Lung results posted | BO39610 2017-001267-21 | Ph 1, Ph 2 | terminated | A Study Of Multiple Immunotherapy-Based Treatment Combinations In Participants With Metastatic Non-Small Cell Lung Cancer (Morpheus- Non-Small Cell Lung Cancer) |
| NCT06851962 EPHIC-DIA2 | EPHIC-DIA2 2025-520686-46-00 | Ph 4 | active not recruiting | Impact of Pharmacogenetic-Guided Treatment on Type 2 Diabetes. |
| NCT03281369 | YO39609 2016-004529-17 | Ph 1, Ph 2 | completed | A Study of Multiple Immunotherapy-Based Treatment Combinations in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Cancer (G/GEJ) or Esophageal Cancer (Morpheus-Gastric and Esophageal Cancer) |
| NCT01734785 results posted | 1275.9 2012-002270-31 | Ph 3 | completed | Safety and Efficacy of the Combination of Empagliflozin and Linagliptin Compared to Linagliptin Alone Over 24 Weeks in Patients With Type 2 Diabetes |
| NCT03429543 results posted | 1218-0091 2016-000669-21 | Ph 3 | completed | Diabetes Study of Linagliptin and Empagliflozin in Children and Adolescents (DINAMO)TM |
| NCT03642184 | RJ20180601NODAT | Ph 4 | terminated | Efficacy and Safety of Empagliflozin in NODAT |
| NCT05886088 DÁLIA | LID104-III-0123 | Ph 3 | not yet recruiting | Efficacy and Safety of LID104 in the Treatment of Type II Diabetes Mellitus |
| NCT02372630 1971 results posted | 514091 | Ph 4 | completed | The Effect of LINAGLIPTIN on Inflammation, Oxidative Stress and Insulin Resistance in Obese Type 2 Diabetes Subjects |
| NCT02467478 results posted | 121439 | Ph 4 | completed | Linagliptin's Effect on CD34+ Stem Cells |
| NCT04341935 | 20200384 | Ph 4 | withdrawn | Effects of DPP4 Inhibition on COVID-19 |
| NCT02851745 DYDA2 | G113 | Ph 3 | completed | Effects of Linagliptin on Left Ventricular Myocardial DYsfunction in Patients With Type 2 DiAbetes Mellitus and Concentric Left Ventricular Geometry |
| NCT02442817 | LING-1 | Ph 4 | completed | Linagliptin and Mesenchymal Stem Cells: A Pilot Study |
| NCT02350478 results posted | HS-2012-01 | Ph 4 | completed | Effects of Linagliptin on Endothelial Function |
| NCT02897349 results posted | 1218.102 | Ph 3 | completed | Linagliptin Add-on to Insulin Background Therapy |
| NCT03259490 results posted | 1361-0003 2017-000425-12 | Ph 1 | completed | This Study Tests Whether Taking the Medicines Empagliflozin, Linagliptin, and Metformin Together in 1 Pill is the Same as Taking Them in Separate Pills. The Study is Done in Healthy Men and Women and Measures the Amount of Each Medicine in the Blood |
| NCT03629054 results posted | 1361-0011 2018-001266-42 | Ph 1 | completed | This Study in Healthy People Tests Whether Taking a Low Strength of Empagliflozin, Linagliptin, and Metformin Together in 1 Pill is the Same as Taking Them in Separate Pills |
| 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) |
| NCT03667300 DA1229 | 2016-08-144 | Ph 2 | completed | Effect of Evogliptin on Albuminuria in Patients With Type 2 Diabetes and Renal Insufficiency |
| NCT01897532 results posted | 1218.22 2011-004148-23 | Ph 4 | completed | Cardiovascular and Renal Microvascular Outcome Study With Linagliptin in Patients With Type 2 Diabetes Mellitus (CARMELINA) |
| NCT03011177 TELIUS | MP_C402 | Ph 4 | completed | Teneligliptin Versus Linagliptin in Diabetes Mellitus Type Two Patients |
| NCT02004366 results posted | IRB00066548 | Ph 4 | completed | Linagliptin Inpatient Trial |
| NCT02453555 results posted | 1275.19 | Ph 3 | completed | Empagliflozin Add on to Linagliptin Study in Japanese Patient With Type 2 Diabetes Mellitus |
| NCT03504566 ROTATE-2 | H-17013487 | Ph 4 | withdrawn | Rotation for Optimal Targeting of Albuminuria and Treatment Evaluation (ROTATE-2) |
| NCT02061969 results posted | IRB00071545 IRB00071946 | Ph 4 | completed | ADA Linagliptin in Long Term Care |
| NCT01943019 | Phamon 001 | Ph 1 | terminated | Linagliptin in Schizophrenia Patients |
| NCT02974504 | DA1229_DM_IV | Ph 4 | completed | Phase IV Clinical Trial to Investigate the Effect on Blood Glucose of Evogliptin in Patients With Type 2 Diabetes(EVERGREEN) |
| NCT02240680 results posted | 1218.149 2014-000904-88 | Ph 4 | completed | Linagliptin as Add on to Basal Insulin in the Elderly |
| NCT02768220 | SGLT2-AGE | Ph 4 | withdrawn | The Effect of Sodium-Glucose Cotransporter 2 Inhibitors on Advanced Glycation End Products |
| NCT02092597 SAFEGUARD | HEALTH-282521-CUNI | Ph 4 | completed | Safety Evaluation of Adverse Reactions in Diabetes |
| NCT01835678 | CRC2012LINA 2012-002278-30 | Ph 3 | completed | Effects of Linagliptin on Renal Endothelium Function in Patients With Type 2 Diabetes. |
| NCT02180334 | H-1311-104-537 2013-2641 | Ph 4 | completed | The Effect of Combination of Mosapride and DPP-4 Inhibitor on Plasma Concentration of Incretin Hormones |
| NCT02758171 results posted | 1275.21 2015-004234-98 | Ph 1 | completed | Bioequivalence of a Fixed Dose Combination Tablet of Empagliflozin/Linagliptin Compared With the Free Combination of Empagliflozin Tablet and Linagliptin Tablet in Healthy Male and Female Subjects |
| NCT02077309 Lina-Plaque | 12-027 111/13, 2012-003859-12 | Ph 3 | terminated | Effect of Linagliptin on Vascular Inflammation in Patients With Type 2 Diabetes Mellitus |
| NCT01888796 Diast Dysfkt | 12-025 2012-003858-81, EK 113/13 | Ph 3 | terminated | Diastolic Dysfunction in Patients With Type 2 Diabetes Mellitus |
| NCT01903070 | 00/0594-LINARI | Ph 4 | completed | Effects of Linagliptin on Active GLP-1 Concentrations in Subjects With Renal Impairment |
| NCT01969084 results posted | 2013P-000057 IIS trial 1218.137 | Ph 4 | completed | The Effect of Linagliptin on Mitochondrial and Endothelial Function |
| NCT01214239 results posted | 1218.66 | Ph 3 | completed | Efficacy and Safety Study of Linagliptin (5 mg Administered Orally Once Daily) Over 24 Weeks, in Drug naïve or Previously Treated Type 2 Diabetic Patients With Insufficient Glycaemic Control |
| NCT01215097 results posted | 1218.65 | Ph 3 | completed | Efficacy and Safety Study of Linagliptin (5 mg Administered Orally Once Daily) Over 24 Weeks in Type 2 Diabetic Patients With Insufficient Glycaemic Control Despite Metformin Therapy |
| NCT02084082 results posted | 1288.9 2013-005142-11 | Ph 1 | completed | Bioequivalence of a FDC Tablet of Linagliptin/Metformin (5mg/1000mg) Extended Release in Healthy Subjects |
| NCT02121509 results posted | 1288.10 2013-005143-85 | Ph 1 | completed | Bioequivalence of a FDC Tablet of Linagliptin/Metformin (2.5mg/750mg) Extended Release in Healthy Subjects |
| NCT02084056 results posted | 1288.11 2013-005144-28 | Ph 1 | completed | Bioequivalence of a FDC Tablet of Linagliptin/Metformin (2.5mg/1000mg) Extended Release in Healthy Subjects. |
| NCT02015299 RELEASE | NL43473.042.13 | Ph 3 | completed | Off taRget Effects of Linagliptin monothErapy on Arterial Stiffness in Early Diabetes |
| NCT02401880 | EMLIN-001 | Ph 4 | completed | Effects of Linagliptin in Addition to Empagliflozin on Islet Cell Physiology |
| NCT01422876 results posted | 1275.1 2011-000383-10 | Ph 3 | completed | Efficacy and Safety of Empagliflozin (BI 10773) / Linagliptin (BI 1356) Fixed Dose Combination in Treatment naïve and Metformin Treated Type 2 Diabetes Patients |
| NCT02376075 | ikfe-Lina-003 2012-004300-35 | Ph 3 | completed | Effects of Linagliptin on Endothelial- , Renal-, and Retinal Function in Patients With Hypertension and Albuminuria |
| NCT01947153 results posted | 1288.21 | Ph 1 | completed | Two-way Crossover Study in Healthy Male and Female Subjects to Evaluate the Bioequivalence of Jentadueto®. |
| NCT01703286 results posted | 1218.105 2012-003317-33 | Ph 1 | completed | 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) |
| NCT01617824 | 2588P | Ph 4 | completed | Rapid Effects Linagliptin on Monocyte Polarization and Endothelial Progenitor Cells in Type 2 Diabetes |
| NCT01438814 results posted | 1218.60 2011-002276-16 | Ph 4 | completed | Linagliptin in Combination With Metformin in Treatment Naive Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control |
Showing 50 of 68 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
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.
JENTADUETO FDA Label Details
Indications & Usage
FDA Label (PDF)JENTADUETO is indicated for the treatment of Type 2 Diabetes.
WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias...
JENTADUETO Patents & Exclusivity
Patents (16 active)
Exclusivity
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Revenue Insights
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Patent Timeline
- • Cliff: 2037
- • 141 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.