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Placebo plus metformin
Metformin reduces hepatic glucose production and improves insulin sensitivity, while the placebo control arm receives no active pharmacological intervention.
Metformin reduces hepatic glucose production and improves insulin sensitivity, while the placebo control arm receives no active pharmacological intervention. Used for Type 2 diabetes mellitus.
At a glance
| Generic name | Placebo plus metformin |
|---|---|
| Sponsor | University Magna Graecia |
| Drug class | Biguanide |
| Target | AMP-activated protein kinase (AMPK), mitochondrial glycerophosphate dehydrogenase |
| Modality | Small molecule |
| Therapeutic area | Diabetes |
| Phase | FDA-approved |
Mechanism of action
Metformin is a biguanide that decreases gluconeogenesis in the liver and enhances peripheral glucose uptake and utilization. In this combination, metformin provides the active therapeutic effect for glycemic control in diabetes, while the placebo component serves as a control comparator in the clinical study design.
Approved indications
- Type 2 diabetes mellitus
Common side effects
- Gastrointestinal disturbance (nausea, diarrhea, abdominal discomfort)
- Metallic taste
- Lactic acidosis (rare)
- Vitamin B12 deficiency
Key clinical trials
- Metformin and Chemotherapy in Treating Patients With Stage III-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (PHASE2)
- Metformin Combined With Secukinumab for Moderate-to-Severe Plaque Psoriasis in Overweight or Obese Chinese Patients (PHASE4)
- Metformin Safety and Efficacy in Osteoarthritis. (PHASE3)
- Drug Therapy Induced Weight Loss to Improve Blood Vessel Function in Subjects With Obesity (PHASE2)
- A Research Study to Compare a New Medicine Oral Semaglutide to a Dummy Medicine in Children and Teenagers With Type 2 Diabetes (PHASE3)
- A Study to Evaluate the Effect of AZD6793 on the Pharmacokinetics and Pharmacodynamics of Metformin in Participants With Type 2 Diabetes Mellitus (PHASE1)
- Stem Cells and Secretomes for Infertility Therapy in Polycystic Ovary Syndrome (PCOS) Patients With Insulin Resistance. (PHASE1, PHASE2)
- Glycemic Regulation as Endometriosis Adjunct Treatment (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:
- Placebo plus metformin CI brief — competitive landscape report
- Placebo plus metformin updates RSS · CI watch RSS
- University Magna Graecia portfolio CI