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Placebo plus metformin IR
Metformin reduces hepatic glucose production and improves insulin sensitivity, while placebo serves as a control comparator in this combination study.
Metformin reduces hepatic glucose production and improves insulin sensitivity, while placebo serves as a control comparator in this combination study. Used for Type 2 diabetes mellitus.
At a glance
| Generic name | Placebo plus metformin IR |
|---|---|
| Sponsor | AstraZeneca |
| Drug class | Biguanide |
| Target | AMP-activated protein kinase (AMPK); mitochondrial glycerophosphate dehydrogenase |
| Modality | Small molecule |
| Therapeutic area | Diabetes |
| Phase | Phase 3 |
Mechanism of action
Metformin IR (immediate-release) is a biguanide that decreases gluconeogenesis in the liver and enhances peripheral glucose uptake and utilization. In this phase 3 trial design, placebo is combined with metformin IR as the control or reference arm to evaluate efficacy and safety outcomes in a diabetes population.
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
- ACTIV-6: COVID-19 Study of Repurposed Medications - Arm G (Metformin) (PHASE3)
- ACTIV-6: COVID-19 Study of Repurposed Medications (PHASE3)
- Metformin Therapy in Non-diabetic AAA Patients (PHASE2, PHASE3)
- Investigational Study of Delayed Release Metformin (PHASE3)
- The RCT of Acupuncture on PCOS Combined With IR (PHASE3)
- Phase 4: Investigational Study to Evaluate Metformin XR Monotherapy Versus Metformin IR Monotherapy in Subjects With Type 2 Diabetes (PHASE4)
- A Study of the Safety and Efficacy of Sitagliptin Addition During Metformin Up-titration (MK-0431-848) (PHASE3)
- A Preliminary Study of the Efficacy and Safety of MK-8521 for Type 2 Diabetes (MK-8521-004) (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 IR CI brief — competitive landscape report
- Placebo plus metformin IR updates RSS · CI watch RSS
- AstraZeneca portfolio CI