PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE (metformin hydrochloride)
This combination product contains pioglitazone (a thiazolidinedione) and metformin hydrochloride (a biguanide). It is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. The therapy is intended for patients who require the combined effects of an insulin sensitizer and an agent that reduces hepatic glucose production. It is not recommended for the treatment of type 1 diabetes or diabetic ketoacidosis.
How PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE Works
This medication combines two antihyperglycemic agents with complementary mechanisms of action: * **Pioglitazone:** A thiazolidinedione that acts as a potent and selective agonist for the nuclear receptor peroxisome proliferator-activated receptor-gamma (PPARγ). Activation of these receptors modulates the transcription of insulin-responsive genes involved in glucose and lipid metabolism. This results in decreased insulin resistance in the liver and peripheral tissues (skeletal muscle and adipose tissue), increased insulin-dependent glucose disposal, and decreased hepatic glucose output. Its action is dependent on the presence of insulin. * **Metformin Hydrochloride:** A biguanide that improves glucose tolerance by decreasing basal and postprandial plasma glucose. It exerts its effects by decreasing hepatic glucose production, decreasing the intestinal absorption of glucose, and improving insulin sensitivity by increasing peripheral glucose uptake and utilization. Unlike sulfonylureas, metformin does not produce hypoglycemia in either patients with type 2 diabetes or healthy subjects (except in special circumstances) and does not cause hyperinsulinemia.
Details
- Status
- Prescription
- First Approved
- 2011-02-25
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE Approval History
What PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE Treats
1 indicationsPIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE is approved for 1 conditions since its original approval in 2011. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Type 2 Diabetes
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE Boxed Warning
CONGESTIVE HEART FAILURE and LACTIC ACIDOSIS Congestive Heart Failure Thiazolidinediones, including pioglitazone, which is a component of pioglitazone and metformin hydrochloride, cause or exacerbate congestive heart failure in some patients [see Warnings and Precautions (5.1) ] . After initiation of pioglitazone and metformin hydrochloride, 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...
WARNING: CONGESTIVE HEART FAILURE and LACTIC ACIDOSIS Congestive Heart Failure Thiazolidinediones, including pioglitazone, which is a component of pioglitazone and metformin hydrochloride, cause or exacerbate congestive heart failure in some patients [see Warnings and Precautions (5.1) ] . After initiation of pioglitazone and metformin hydrochloride, 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 congestive heart failure develops while taking pioglitazone and metformin hydrochloride, consider discontinuation of pioglitazone and metformin hydrochloride or dosage reduction of pioglitazone in pioglitazone and metformin hydrochloride [see Warnings and Precautions (5.1) ] . Pioglitazone and metformin hydrochloride is not recommended in patients with symptomatic heart failure [see Warnings and Precautions (5.1) ] . Initiation of pioglitazone and metformin hydrochloride in patients with established New York Heart Association (NYHA) Class III or IV heart failure is contraindicated [see Contraindications (4) , Warnings and Precautions (5.1) ] . 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 (greater than 5 mmol/L), anion gap acidosis (without evidence of ketonuria or ketonemia), an increased lactate:pyruvate ratio; and metformin plasma levels generally greater than 5 mcg/mL [see Warnings and Precautions (5.2) ] . Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (e.g., carbonic anhydrase inhibitors such as topiramate), age 6
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE Competitive Set
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Same target(s) AND same indication — head-to-head.
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 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE treats. First-in-class if their pivotal trials read out positive.
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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.
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE FDA Label Details
Indications & Usage
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE is indicated for the treatment of Type 2 Diabetes.
WARNING: CONGESTIVE HEART FAILURE and LACTIC ACIDOSIS Congestive Heart Failure Thiazolidinediones, including pioglitazone, which is a component of pioglitazone and metformin hydrochloride, cause or exacerbate congestive heart failure in some patients [see Warnings and Precautions (5.1) ] . After ini...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.