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metformin and roflumilast
This combination uses metformin to improve insulin sensitivity and glucose metabolism while roflumilast reduces airway inflammation by inhibiting phosphodiesterase-4.
This combination uses metformin to improve insulin sensitivity and glucose metabolism while roflumilast reduces airway inflammation by inhibiting phosphodiesterase-4. Used for Type 2 diabetes mellitus with concurrent COPD (investigational combination).
At a glance
| Generic name | metformin and roflumilast |
|---|---|
| Also known as | Glucophage tablets and Daxas 500 micrograms film-coated tablets |
| Sponsor | University Medical Centre Ljubljana |
| Drug class | Combination therapy: biguanide and phosphodiesterase-4 inhibitor |
| Target | Metformin: mitochondrial glycerophosphate dehydrogenase; Roflumilast: phosphodiesterase-4 (PDE-4) |
| Modality | Small molecule |
| Therapeutic area | Endocrinology and Respiratory |
| Phase | FDA-approved |
Mechanism of action
Metformin decreases hepatic glucose production and improves peripheral insulin sensitivity, primarily used in type 2 diabetes. Roflumilast is a phosphodiesterase-4 (PDE-4) inhibitor that increases intracellular cAMP levels in inflammatory cells, reducing the production of pro-inflammatory mediators. The combination targets both metabolic and inflammatory pathways, potentially beneficial in patients with concurrent diabetes and chronic obstructive pulmonary disease (COPD).
Approved indications
- Type 2 diabetes mellitus with concurrent COPD (investigational combination)
Common side effects
- Gastrointestinal disturbance (metformin)
- Nausea (roflumilast)
- Diarrhea (metformin)
- Headache (roflumilast)
- Weight loss (roflumilast)
- Lactic acidosis (metformin, rare)
Key clinical trials
- Clinical Study Evaluating the Safety and Efficacy of Roflumilast in Type 2 Diabetic Patients With Diabetic Neuropathy (PHASE3)
- Roflumilast Plus Alogliptin Proof-of-Mechanism Study in Type2 Diabetes (PHASE1)
- PDE-4 Inhibitor Roflumilast and GLP-1 Agonist Liraglutide in Polycystic Ovary Syndrome (PHASE4)
- PDE-4 Inhibitor Roflumilast and Polycystic Ovary Syndrome (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:
- metformin and roflumilast CI brief — competitive landscape report
- metformin and roflumilast updates RSS · CI watch RSS
- University Medical Centre Ljubljana portfolio CI