Last reviewed · How we verify
Placebo matching with Metformin IR
This is a placebo-matched formulation used in clinical trials to maintain blinding while comparing against Metformin IR (immediate-release), which reduces hepatic glucose production and improves insulin sensitivity.
This is a placebo-matched formulation used in clinical trials to maintain blinding while comparing against Metformin IR (immediate-release), which reduces hepatic glucose production and improves insulin sensitivity. Used for Used as control arm in clinical trials for type 2 diabetes or related metabolic disorders.
At a glance
| Generic name | Placebo matching with Metformin IR |
|---|---|
| Sponsor | Bristol-Myers Squibb |
| Drug class | Placebo (trial formulation); comparator is biguanide |
| Modality | Small molecule |
| Therapeutic area | Diabetes |
| Phase | FDA-approved |
Mechanism of action
Placebo matching refers to a dummy formulation designed to be indistinguishable from the active drug in appearance and administration schedule, used to preserve trial blinding. The active comparator, Metformin IR, is a biguanide that decreases hepatic gluconeogenesis and enhances peripheral glucose uptake by activating AMP-activated protein kinase (AMPK). This combination is typical in randomized controlled trials evaluating new antidiabetic agents against the metformin standard of care.
Approved indications
- Used as control arm in clinical trials for type 2 diabetes or related metabolic disorders
Common side effects
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)
- 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)
- Dose-Ranging Study to Evaluate the Glycemic Effects, Safety, and Tolerability of Metformin Delayed Release in Subjects With T2DM (PHASE2)
- A Study To Evaluate The Safety,Tolerability, PK and PD Of DA-1241 In Healthy Male Subjects (PHASE1)
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 matching with Metformin IR CI brief — competitive landscape report
- Placebo matching with Metformin IR updates RSS · CI watch RSS
- Bristol-Myers Squibb portfolio CI