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Metformin (open-label)
Metformin reduces hepatic glucose production and improves insulin sensitivity by activating AMP-activated protein kinase (AMPK) and inhibiting mitochondrial complex I.
Metformin reduces hepatic glucose production and improves insulin sensitivity by activating AMP-activated protein kinase (AMPK) and inhibiting mitochondrial complex I. Used for Type 2 diabetes mellitus, Prediabetes (prevention of progression to type 2 diabetes).
At a glance
| Generic name | Metformin (open-label) |
|---|---|
| Also known as | Glucophage |
| Sponsor | Medical College of Wisconsin |
| Drug class | Biguanide |
| Target | AMP-activated protein kinase (AMPK); mitochondrial complex I |
| Modality | Small molecule |
| Therapeutic area | Diabetes |
| Phase | Phase 3 |
Mechanism of action
Metformin decreases gluconeogenesis in the liver and enhances glucose uptake and utilization in peripheral tissues, primarily through AMPK activation. It also improves insulin sensitivity and may have indirect effects on gut microbiota and incretin secretion. The drug does not stimulate insulin secretion, making it weight-neutral and suitable for use across a broad range of glucose levels.
Approved indications
- Type 2 diabetes mellitus
- Prediabetes (prevention of progression to type 2 diabetes)
Common side effects
- Gastrointestinal disturbance (nausea, diarrhea, abdominal discomfort)
- Metallic taste
- Vitamin B12 deficiency
- Lactic acidosis (rare, in renal impairment)
Key clinical trials
- Study to Evaluate the Effect of Repotrectinib on the Drug Levels of Transporter and CYP P450 Probe Substrates in Healthy Adult Participants (PHASE1)
- Modular Clinical Pharmacology Study to Evaluate the Drug-drug Interaction Potential and Relative Bioavailability of Saruparib (PHASE1)
- Metformin for People With CFRD on CFTR Modulator Therapy to Improve Ion Channel Function (PHASE2)
- Safety and Tolerability of Metformin in People With Tuberculosis (TB) and Human Immunodeficiency Virus (HIV) (PHASE2)
- A Study in Healthy People to Test Whether BI 764198 Influences the Amount of Metformin in the Body (PHASE1)
- An Efficacy and Safety Study of Erdafitinib (JNJ-42756493) in Participants With Urothelial Cancer (PHASE2)
- A Study to Evaluate the Effect of add-on Pioglitazone or Dapagliflozin in Participants With Type 2 Diabetes Mellitus Inadequately Controlled by DPP-4 Inhibitor and Metformin Therapy (PHASE4)
- Ameliorating Metabolic Profiling After Kidney Transplantation (AMPKT) (NA)
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 (open-label) CI brief — competitive landscape report
- Metformin (open-label) updates RSS · CI watch RSS
- Medical College of Wisconsin portfolio CI