SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE (metformin hydrochloride)
This medication helps adults with type 2 diabetes manage their blood sugar levels alongside diet and exercise. It combines two different medicines to provide better glycemic control by lowering both fasting and post-meal glucose levels. It is not used for patients with type 1 diabetes or those experiencing diabetic ketoacidosis.
How SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE Works
This drug works by slowing the breakdown of natural hormones that trigger insulin release while simultaneously reducing the amount of sugar the liver produces and the intestines absorb. By keeping these hormones active longer, it helps the pancreas release insulin more effectively in response to food and improves how the body's cells use existing insulin.
Details
- Status
- Discontinued
- First Approved
- 2023-07-31
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE
Companies
SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE Approval History
What SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE Treats
3 indicationsSAXAGLIPTIN AND METFORMIN HYDROCHLORIDE is approved for 3 conditions since its original approval in 2023. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Type 2 Diabetes
- Type 1 Diabetes
- Diabetic Ketoacidosis
SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE Boxed Warning
LACTIC ACIDOSIS • Post-marketing 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 keto...
WARNING: LACTIC ACIDOSIS • Post-marketing 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 saxagliptin and metformin hydrochloride extended-release tablets 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 . • Post-marketing 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 includ
SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE 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.
SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
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 SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE
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Clinical Trial Registry
72 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04545736 | 200163 20-EI-0163 | Ph 1, Ph 2 | recruiting | Oral Metformin for Treatment of ABCA4 Retinopathy |
| NCT06638671 | HSR240014 | Ph 4 | active not recruiting | Short-Term Metformin Use in Young, Healthy Adults: Impacts on Exercise Capacity |
| NCT01905046 results posted | A211102 U10CA031946, NCI-2013-00995 | Ph 3 | active not recruiting | Metformin Hydrochloride in Preventing Breast Cancer in Patients With Atypical Hyperplasia or In Situ Breast Cancer |
| NCT02874430 results posted | 16D.317 JT 8988 | Ph 2 | terminated | Metformin Hydrochloride and Doxycycline in Treating Patients With Localized Breast or Uterine Cancer |
| NCT04530383 | STUDY00146063/STUDY00161734 R01HL157942-01 | Ph 2 | recruiting | Metformin for People With CFRD on CFTR Modulator Therapy to Improve Ion Channel Function |
| NCT07368569 | 1434-0005 2025-522432-14, U1111-1322-9764 | Ph 1 | completed | A Study in Healthy People to Test Whether BI 764198 Influences the Amount of Metformin in the Body |
| NCT02581137 results posted | NCI-2015-01733 NCI-2015-01733, HHSN2612012000311 | Ph 2 | active not recruiting | Metformin Hydrochloride in Preventing Oral Cancer in Patients With an Oral Premalignant Lesion |
| NCT05445791 METLUNG | (020/023/ICI) (CEI/1421/19) | Ph 3 | recruiting | Metformin Plus Tyrosine Kinase Inhibitors for Treatment of Patients With Non-small Cell Lung Cancer With EGFR Mutations |
| NCT03514108 DANHEART | DANHEART 2015-002150-12 | Ph 4 | completed | DANHEART (H-HeFT and Met-HeFT) |
| NCT02122185 results posted | IRB13-1235 NCI-2014-00860, IRB13-1235 | Ph 2 | completed | Metformin and Chemotherapy in Treating Patients With Stage III-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer |
| NCT06899061 | D9723C00002 2024-513692-41-00 | Ph 1 | active not recruiting | Modular Clinical Pharmacology Study to Evaluate the Drug-drug Interaction Potential and Relative Bioavailability of Saruparib |
| NCT06611501 GREAT | IRB-P00049391 | Ph 2 | recruiting | Glycemic Regulation as Endometriosis Adjunct Treatment |
| NCT07387900 | OMED 3.7.2 | Ph 2 | recruiting | Evaluation of the Chemo-preventive Effect of Combined Topical and Systemic Metformin on Oral Leukoplakia |
| NCT02336087 | 14122 NCI-2014-02612, 14122 | Ph 1 | active not recruiting | Gemcitabine Hydrochloride, Paclitaxel Albumin-Stabilized Nanoparticle Formulation, Metformin Hydrochloride, and a Standardized Dietary Supplement in Treating Patients With Pancreatic Cancer That Cannot be Removed by Surgery |
| NCT03076281 results posted | 16D.703 JT 9611 | Ph 2 | terminated | Metformin Hydrochloride and Doxycycline in Treating Patients With Head and Neck Squamous Cell Carcinoma |
| NCT06504862 results posted | 1479-0015 2024-510628-38-00, U1111-1302-1171 | Ph 1 | completed | A Study in Healthy Men to Test Whether Zongertinib Influences the Amount of 4 Other Medicines (Dabigatran, Rosuvastatin, Metformin, and Furosemide) in the Blood |
| NCT04221750 DEMFOS | ENDA-007-19F H-46970 | Ph 3 | completed | Diet and Exercise Plus Metformin to Treat Frailty in Obese Seniors |
| NCT03109847 results posted | 16D.564 JT 9411 | Ph 2 | terminated | Metformin to Mitigate Sequelae of Radioactive Iodine Treatment for Thyroid Cancers |
| NCT05680805 | BSMMU/2022/9559-768 | Ph 4 | active not recruiting | Metabolic Responses of Metformin and Genetic Polymorphisms of SLC22A1 Gene in PCOS |
| NCT06707012 | frpmc.edu.pk@sadiakhan12345678 FMC, University | Ph 4 | recruiting | Efficacy of Metformin as an Adjunct to Standard Antidepressant Therapy in Treating Depression Among Obese Patients |
| NCT06920056 | BGM0504-DDI | Ph 1 | completed | A Study of BGM0504 in Overweight or Obese Participants |
| NCT01430351 | 2011-0374 NCI-2011-03038, 2011-0374 | Ph 1 | terminated | Temozolomide, Memantine Hydrochloride, Mefloquine, and Metformin Hydrochloride in Treating Patients With Glioblastoma Multiforme After Radiation Therapy |
| NCT06332612 MROSF | 8420224AROM | Ph 1, Ph 2 | completed | Metformin Repurposing in Oral Submucous Fibrosis: Unveiling In Vitro Signaling Pathways, Progressing to Clinical Trial |
| NCT02339168 | 680462 UCDCC#243, UCDCC#243 | Ph 1 | completed | Enzalutamide and Metformin Hydrochloride in Treating Patients With Hormone-Resistant Prostate Cancer |
| NCT05828303 | CA127-1027 | Ph 1 | withdrawn | A Phase 1 Study to Evaluate the Potential Drug Interactions Between Repotrectinib and Metformin, Digoxin, and Rosuvastatin in Patients With Advanced Solid Tumors |
| NCT02980276 EMERGE results posted | NUIG-2016-01 | Ph 3 | completed | RCT Metformin for Reduction of Gestational Diabetes Mellitus Effects |
| NCT06655220 | 1485-0013 2024-515911-23-00, U1111-1306-9403 | Ph 1 | completed | A Study in Healthy Men to Test Whether BI 1815368 Influences the Amount of Metformin in the Body |
| NCT05607316 | STUDY00000630 | Ph 2 | withdrawn | Evaluating the Efficacy and Safety of Metformin in Vitiligo |
| NCT03829020 | MC1811 NCI-2019-00466, MC1811 | Ph 1 | completed | Metformin, Nelfinavir, and Bortezomib in Treating Patients With Relapsed and/or Refractory Multiple Myeloma |
| NCT03331861 Met-HeFT results posted | AAAR5389 | Ph 2 | terminated | Metformin in Heart Failure Without Diabetes |
| NCT04807348 | CGZ303 | Ph 3 | completed | Chiglitazar Added to Metformin for Type 2 Diabetes |
| NCT03733132 results posted | 18-004012 1R21AG060139-01 | Ph 2 | completed | Metformin Effect on Brain Function in Insulin Resistant Elderly People |
| NCT06452498 PI-NL | PI-NL trial 2023-510382-10-00 | Ph 3 | not yet recruiting | Preeclampsia Intervention Netherlands |
| NCT04267809 | Met-YF-001 | Ph 2 | completed | Modulate Cellular Stress in the Immune Cells to Reduce Rate of Symptomatic Viral Infection |
| NCT04593459 ProPCO-RCT | 160120200001 2020-000228-20 | Ph 4 | completed | Probiotic Intervention in PCOS |
| NCT05590676 | 3987 | Ph 1 | terminated | Metformin Treatment in Infants After Perinatal Brain Injury |
| NCT06170463 | ZU-IRB#11195-21/6-2023 | Ph 1 | completed | Insulin Sensitizers Role in Control of PCOS Vicious Cycle. |
| NCT02854527 results posted | 352.2096 2016-001893-14 | Ph 1 | completed | Transporter Cocktail Mutual Interaction |
| NCT02231931 | 352.2082 2014-001940-40 | Ph 1 | completed | Drug-drug Interaction Between Digoxin, Furosemide, Metformin, and Rosuvastatin |
| NCT02068443 results posted | SYR-322-MET/CCT-001 JapicCTI-132377, U1111-1151-6515 | Ph 3 | completed | Comparative Study to Evaluate Efficacy and Safety When Metformin Hydrochloride 500 mg Once Daily is Added on to SYR-322 25 mg in Type 2 Diabetic Patients With Inadequate Glycemic Control Despite Treatment With SYR-322 25 mg in Addition to Diet and Exercise Therapy |
| NCT01101438 results posted | MA32 U10CA077202, CAN-NCIC-MA.32 | Ph 3 | completed | A Phase III Randomized Trial of Metformin vs Placebo in Early Stage Breast Cancer |
| NCT06012682 METIN | 2021/ABM/03/00006 | Ph 2 | not yet recruiting | Clinical Trials Evaluating the Effect of Metformin Treatment on Function Endometrium in Women Diagnosed With Idiopathic Infertility |
| NCT04758000 Metform-Bone | 794/2020/Farm/IOR 2020-002579-37 | Ph 2 | recruiting | Metformin as Maintenance Therapy in Patients With Bone Sarcoma and High Risk of Relapse |
| NCT05177588 | CL (2582) | Ph 4 | completed | Efficacy of Metformin as add-on Therapy in Non-Diabetic Heart Failure Patients |
| NCT05768360 | D5084C00014 2022-003785-21 | Ph 1 | completed | A Study to Assess the Effects of Savolitinib on the Pharmacokinetics of Digoxin, Rosuvastatin, Metformin, and Furosemide in Healthy Male Subjects |
| NCT02420652 PRIMA results posted | 081501 NCI-2015-00397, Pro20150001378 | Ph 2 | terminated | Metformin Hydrochloride and Aspirin in Treating Patients With Hormone-Dependent Prostate Cancer That Has Progressed After Surgery or Radiation Therapy |
| NCT05451147 | N.F.5(283)/2013-CO | Ph 3 | completed | A Comparative Study of the Effect of Ayurvedic Drugs and Metformin in the Management of Diabetes Mellitus (Type II) |
| NCT03359681 MECORA | REG-096-2017 | Ph 2 | completed | Metformin Treatment for Colon Cancer |
| NCT01666730 results posted | CASE1212 | Ph 2 | completed | Metformin Plus Modified FOLFOX 6 in Metastatic Pancreatic Cancer |
| NCT04943692 COMETII | SIL-30000-III-19(1) | Ph 3 | suspended | Efficacy and Safety of Metformin Glycinate Compared to Metformin Hydrochloride on the Progression of Type 2 Diabetes |
Showing 50 of 72 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.
SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE FDA Label Details
Indications & Usage
SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE is indicated for the treatment of Type 2 Diabetes; Type 1 Diabetes; Diabetic Ketoacidosis.
WARNING: LACTIC ACIDOSIS • Post-marketing 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, myalg...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.