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Sitagliptin plus metformin
Sitagliptin plus metformin is a DPP-4 inhibitor and biguanide Small molecule drug developed by Merck Sharp & Dohme LLC. It is currently in Phase 3 development for Type 2 diabetes, Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Also known as: MK-0431A, MK-0431A XR.
Sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, increases incretin levels, enhancing glucose-dependent insulin secretion, and metformin, a biguanide, decreases hepatic glucose production and increases insulin sensitivity.
Sitagliptin, a dipeptidyl peptidase IV inhibitor, is used in combination with metformin to treat Type 2 Diabetes. This combination is classified as a small molecule inhibitor of the Dipeptidyl peptidase 4 enzyme.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Big-pharma sponsor
+3.0pp
Merck Sharp & Dohme LLC is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Sitagliptin plus metformin |
|---|---|
| Also known as | MK-0431A, MK-0431A XR |
| Sponsor | Merck Sharp & Dohme LLC |
| Drug class | DPP-4 inhibitor and biguanide |
| Target | DPP-4 |
| Modality | Small molecule |
| Therapeutic area | Diabetes |
| Phase | Phase 3 |
Mechanism of action
Sitagliptin works by inhibiting the enzyme DPP-4, which breaks down incretin hormones. This leads to an increase in incretin levels, which in turn stimulates the release of insulin from the pancreas. Metformin, on the other hand, decreases the production of glucose in the liver and increases the body's sensitivity to insulin, making it easier for glucose to enter the cells.
Approved indications
- Type 2 diabetes
- Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes
Common side effects
- Nausea
- Diarrhea
- Vomiting
- Abdominal pain
- Headache
- Muscle pain
- Fatigue
Key clinical trials
- Comparative Effectiveness of Two Initial Combination Therapies in Patients With Recent Onset Diabetes (PHASE3)
- Metformin, Empagliflozin With Sitagliptin vs Linagliptin in Type 2 Diabetes (PHASE4)
- Effect of Dapagliflozin vs Sitagliptin on Liver Fat Accumulation and Body Composition in Patients With Diabetes Mellitus and Liver Transplantation (NA)
- Impact of Pharmacogenetic-Guided Treatment on Type 2 Diabetes. (PHASE4)
- Triple Hypoglycemic Regimens In Patients With Newly Diagnosed Type 2 Diabetes Mellitus (PHASE1, PHASE2)
- Evaluate the Efficacy and Safety of Empagliflozin or Glimepiride Combination Therapy in Type 2 Diabetes Mellitus Patients (PHASE4)
- iSGLT2 Inhibitor and a iDPP -4 Inhibitor in Treatment of Type 2 Diabetes Mellitus in Patients Treated With Metformin (TRIAD) (PHASE3)
- Canagliflozin and Myocardial Fibrosis (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:
- Sitagliptin plus metformin CI brief — competitive landscape report
- Sitagliptin plus metformin updates RSS · CI watch RSS
- Merck Sharp & Dohme LLC portfolio CI
Frequently asked questions about Sitagliptin plus metformin
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Related
- Drug class: All DPP-4 inhibitor and biguanide drugs
- Target: All drugs targeting DPP-4
- Manufacturer: Merck Sharp & Dohme LLC — full pipeline
- Therapeutic area: All drugs in Diabetes
- Indication: Drugs for Type 2 diabetes
- Indication: Drugs for Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes
- Also known as: MK-0431A, MK-0431A XR
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing