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Metformin alone
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).
At a glance
| Generic name | Metformin alone |
|---|---|
| Also known as | metformin |
| Sponsor | Mount Sinai Hospital, Canada |
| 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 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 mitochondrial function and metabolic pathways. 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
- Modular Clinical Pharmacology Study to Evaluate the Drug-drug Interaction Potential and Relative Bioavailability of Saruparib (PHASE1)
- Diabetes Management for Primary Healthcare Centers. (NA)
- 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)
- Adding 1% Metformin Gel to Bone Graft in Association With Immediate Dental Implants (NA)
- 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)
- Study of Pharmacologic Manipulation of AGE (Advanced Glycation Endproducts) Levels in Prostate Cancer Patients Receiving Androgen Deprivation Therapy (PHASE2)
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 alone CI brief — competitive landscape report
- Metformin alone updates RSS · CI watch RSS
- Mount Sinai Hospital, Canada portfolio CI