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Metformin (Background drug)
Metformin reduces hepatic glucose production and improves insulin sensitivity by activating AMP-activated protein kinase (AMPK).
Metformin reduces hepatic glucose production and improves insulin sensitivity by activating AMP-activated protein kinase (AMPK). Used for Type 2 diabetes mellitus, Prediabetes (prevention of progression to type 2 diabetes), Polycystic ovary syndrome (PCOS).
At a glance
| Generic name | Metformin (Background drug) |
|---|---|
| Sponsor | Sanofi |
| Drug class | Biguanide |
| Target | AMP-activated protein kinase (AMPK); Complex I of the mitochondrial electron transport chain |
| Modality | Small molecule |
| Therapeutic area | Diabetes |
| Phase | Phase 3 |
Mechanism of action
Metformin is a biguanide that primarily works by decreasing gluconeogenesis in the liver and enhancing peripheral glucose uptake and utilization. It activates AMPK, a key metabolic regulator, which suppresses mTORC1 signaling and reduces hepatic glucose output. Additionally, metformin may improve insulin sensitivity in muscle and adipose tissue, making it effective for glycemic control in type 2 diabetes.
Approved indications
- Type 2 diabetes mellitus
- Prediabetes (prevention of progression to type 2 diabetes)
- Polycystic ovary syndrome (PCOS)
Common side effects
- Gastrointestinal disturbance (nausea, diarrhea, abdominal discomfort)
- Metallic taste
- Vitamin B12 deficiency
- Lactic acidosis (rare, in renal impairment)
Key clinical trials
- A Research Study to Compare a New Medicine Oral Semaglutide to a Dummy Medicine in Children and Teenagers With Type 2 Diabetes (PHASE3)
- Phase III Trial of SGLT2 Inhibitor and Thiazolidinedione Fixed-Dose Combination vs. Monotherapy in Type 2 Diabetes Patients on Metformin (PHASE3)
- A Research Study to Compare Two Semaglutide Medicines in People With Type 2 Diabetes (PHASE3)
- To Assess the Risk of Acute Pancreatitis in Patients With Type 2 Diabetes Mellitus Treated With Empagliflozin
- Henagliflozin in Relieving Type 2 Diabetes With Non-alcoholic Fatty Liver Disease (PHASE4)
- Phase 3 Alogliptin Pediatric Study (PHASE3)
- Head-to-head Comparison of Empagliflozin and Dapagliflozin
- A Study on Safety, Pharmacokinetics and Pharmacodynamics of Lixisenatide in Pediatric Patients With Type 2 Diabetes Mellitus (T2DM) (PHASE1)
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:
- Metformin (Background drug) CI brief — competitive landscape report
- Metformin (Background drug) updates RSS · CI watch RSS
- Sanofi portfolio CI