Last reviewed · How we verify
or Metformin HCl alone
Metformin HCl reduces hepatic glucose production and improves insulin sensitivity, thereby lowering blood glucose levels in patients with type 2 diabetes.
Metformin HCl reduces hepatic glucose production and improves insulin sensitivity, thereby lowering blood glucose levels in patients with type 2 diabetes. Used for Type 2 diabetes mellitus, Prediabetes (off-label or prevention studies), Polycystic ovary syndrome (PCOS) with insulin resistance.
At a glance
| Generic name | or Metformin HCl alone |
|---|---|
| Sponsor | Bristol-Myers Squibb |
| Drug class | Biguanide |
| Target | AMP-activated protein kinase (AMPK); mitochondrial glycerophosphate dehydrogenase |
| Modality | Small molecule |
| Therapeutic area | Diabetes |
| Phase | FDA-approved |
Mechanism of action
Metformin is a biguanide that primarily works by decreasing gluconeogenesis in the liver and enhancing peripheral glucose uptake and utilization. It does not stimulate insulin secretion, making it weight-neutral and useful across a broad range of glycemic control needs. The drug also has modest effects on lipid metabolism and may reduce cardiovascular risk.
Approved indications
- Type 2 diabetes mellitus
- Prediabetes (off-label or prevention studies)
- Polycystic ovary syndrome (PCOS) with insulin resistance
Common side effects
- Gastrointestinal disturbance (nausea, diarrhea, abdominal discomfort)
- Metallic taste
- Vitamin B12 deficiency (with long-term use)
- Lactic acidosis (rare, in renal impairment)
Key clinical trials
- Modular Clinical Pharmacology Study to Evaluate the Drug-drug Interaction Potential and Relative Bioavailability of Saruparib (PHASE1)
- Safety and Tolerability of Metformin in People With Tuberculosis (TB) and Human Immunodeficiency Virus (HIV) (PHASE2)
- Effects of Cofrogliptin on Beta-Cell Function in LADA Patients (NA)
- An Efficacy and Safety Study of Erdafitinib (JNJ-42756493) in Participants With Urothelial Cancer (PHASE2)
- To Evaluate the Safety, Tolerability, and Pharmacokinetics of Inavolisib Single Agent in Participants With Solid Tumors and in Combination With Endocrine and Targeted Therapies in Participants With Breast Cancer (PHASE1)
- A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol/Norethindrone, Metformin,Carbamazepine, Rosuvastatin, and Methotrexate When Administered Together (PHASE1)
- Metformin for Motor and Cognitive Improvement in Children With Cerebral Palsy: A Feasibility Study (PHASE2)
- Oral Anti Diabetic Agents in the Hospital (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- or Metformin HCl alone CI brief — competitive landscape report
- or Metformin HCl alone updates RSS · CI watch RSS
- Bristol-Myers Squibb portfolio CI