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Open-label Metformin
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.
At a glance
| Generic name | Open-label Metformin |
|---|---|
| Also known as | Fortamet®, Glucophage®, Glucophage® XR, Glumetza®, Riomet® |
| Sponsor | Merck Sharp & Dohme LLC |
| Drug class | Biguanide |
| Target | AMP-activated protein kinase (AMPK) |
| 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 improving peripheral glucose uptake and utilization. It may also enhance insulin signaling and reduce intestinal glucose absorption, leading to improved glycemic control without stimulating insulin secretion.
Approved indications
- Type 2 diabetes mellitus
Common side effects
- Gastrointestinal disturbance (nausea, diarrhea, abdominal discomfort)
- Metallic taste
- Vitamin B12 deficiency
- Lactic acidosis (rare)
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:
- Open-label Metformin CI brief — competitive landscape report
- Open-label Metformin updates RSS · CI watch RSS
- Merck Sharp & Dohme LLC portfolio CI