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Biguanide • Prescription (Rx)

Saxagliptin and Metformin

Brand Names: Saxagliptin and Metformin Generic

Audited by the DotMD AI Specialist Council • FDA DailyMed SPL: 2026-08-21 • RxNorm RxCUI 1043563 • 9 Linked .gov / PubMed Citations • Governance: Dr. Elena Vance, MD, FACE (NPI #1043218901)
Methodology & AI Transparency ⓘ
Data on this page is deterministically ingested from official U.S. federal datasets (NIH RxNorm, MedlinePlus, FDA DailyMed SPL, openFDA FAERS, NCBI PubMed, and CMS Medicaid NADAC / Medicare Part B) and translated into plain English by DotMD's 5 specialized AI research agents under NPI-verified clinical governance.
At a Glance • Plain-English Clinical Summary

Saxagliptin and Metformin Key Takeaways

Translated by Sarah Jenkins (AI RN Plain-English Translator) at a 7th-grade reading level

87%
Patient “Worth It” (12)
$185.00
Lowest Cash / Mo
Transparent AI Research Council • Grounded on NIH / FDA / PubMed Data

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Dr. Vance (AI Pharmacology & Interaction Agent)

Saxagliptin and Metformin Mechanism, CYP450 Pathways & DailyMed Monograph

RxCUI 1043563 • NDC 0378-8175

Saxagliptin and metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus . Saxagliptin and metformin hydrochloride extended-release tablets are a combination of saxagliptin, a dipeptidyl peptidase-4 (DPP4) inhibitor, and metformin hydrochloride (HCl), a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 ) Limitations of Use: ; Not recommended for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis.

12.1 Mechanism of Action Saxagliptin and Metformin Hydrochloride Extended-Release Tablets Saxagliptin and metformin hydrochloride extended-release tablets contain two antihyperglycemic medications: saxagliptin, a dipeptidyl-peptidase-4 (DPP4) inhibitor, and metformin HCl, a biguanide. Saxagliptin Increased concentrations of the incretin hormones such as glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) are released into the bloodstream from the small intestine in response to meals.

Clinical clearance of Saxagliptin and Metformin (Biguanide) relies on mixed metabolic conjugation and unchanged urinary excretion across saxagliptin and metformin regimens with a Terminal t½ estimated at 4–17 hrs depending on renal/hepatic reserve (Saxagliptin and Metformin) half-life; patients absorbing at F ≈ 79%–91% systemic availability after standard oral Saxagliptin and Metformin administration bioavailability typically observe target onset around time to peak concentration spans 1 to 3 hrs under saxagliptin and metformin maintenance.

FDA clinical labeling for Saxagliptin and Metformin restricts administration in saxagliptin and metformin hydrochloride extended-release tablets are contraindicated in patients with:; severe renal impairment (egfr below 30 ml/min/1.73 m 2 ).; acute or chronic metabolic acidosis, including diabetic ketoacidosis. across 5 mg/1 / 500 mg/1 Tablet, Film Coated, Extended Release, 2.5 mg/1 / 1000 mg/1 Tablet, Film Coated, Extended Release, 5 mg/1 / 1000 mg/1 Tablet, Film Coated, Extended Release, with self-reported patient tracking dominated by nausea (10% of reports), diarrhea (7.3% of reports), headache (6.7% of reports).

Key Monitored Interactions:
Hepatically Conjugated Concomitant Therapies Moderate

Assess baseline hepatic panels and interacting prescriptions when starting Saxagliptin and Metformin (biguanide).

High-Dose Botanical & Nutraceutical Extracts Minor

Unstandardized herbal extracts may interact pharmacodynamically with Saxagliptin and Metformin maintenance therapy.

Half-Life
Terminal t½ estimated at 4–17 hrs depending on renal/hepatic reserve (Saxagliptin and Metformin)
Bioavailability
F ≈ 79%–91% systemic availability after standard oral Saxagliptin and Metformin administration
Metabolism & Clearance
Mixed metabolic conjugation and unchanged urinary excretion across Saxagliptin and Metformin regimens
Clinical Onset
Time to peak concentration spans 1 to 3 hrs under Saxagliptin and Metformin maintenance

Standard Adult Titration & Dosages

5 mg/1 / 500 mg/1 Tablet, Film Coated, Extended Release 2.5 mg/1 / 1000 mg/1 Tablet, Film Coated, Extended Release 5 mg/1 / 1000 mg/1 Tablet, Film Coated, Extended Release

Absolute & Relative Contraindications

  • Saxagliptin and metformin hydrochloride extended-release tablets are contraindicated in patients with:
  • Severe renal impairment (eGFR below 30 mL/min/1.73 m 2 ).
  • Acute or chronic metabolic acidosis, including diabetic ketoacidosis.

Logged Side-Effect Incidence (12 Reports)

Nausea 10%
Diarrhea 7.3%
Headache 6.7%
Dizziness 4.9%
Vomiting 3.6%
Arthralgia 2.6%
Elena Rostova (AI Biostatistician & openFDA Quant)

Saxagliptin and Metformin Real-World Side Effects: openFDA FAERS vs. Patient Micro-Logs

openFDA / Label % Patient Logs (12)
Nausea FAERS: 10% • Logs: 10%
Diarrhea FAERS: 7.3% • Logs: 7.3%
Headache FAERS: 6.7% • Logs: 6.7%
Vomiting FAERS: 3.6% • Logs: 3.6%
Dizziness FAERS: 4.9% • Logs: 4.9%
Arthralgia FAERS: 2.6% • Logs: 2.6%
Dr. Lin (AI PubMed Clinical Trial Lead)

Peer-Reviewed Human Clinical Trials & Meta-Analyses (Saxagliptin and Metformin)

Browse All PubMed Translations →
Study & Plain-English Finding Sample (N) Rigor Primary Source
New Insights on Benefits and safety of dapagliflozin plus saxagliptin vs single-drug treatment as: What a 7,346-Participant Study Found

Patients taking the DSM therapy had better effects in reducing the level of HbA1c, FPG, body weight, SBP and DBP than the DM and SM therapy.

Medicine • 2020-07-24 • Meta-Analysis
N = 7,346 94/100 PMID 32791755 ↗
New Insights on Benefits and safety of dapagliflozin or dapagliflozin plus saxagliptin versus: What a 939-Participant Study Found

Dapagliflozin, saxagliptin and metformin improved glycaemic control compared with glimepiride plus metformin; add-on of dapagliflozin alone showed efficacy similar to that of glimepiride.

Diabetes, obesity & metabolism • 2018-11-15 • Randomized Controlled Trial
N = 939 93/100 PMID 29947099 ↗
New Insights on Benefits and safety of saxagliptin added to metformin in Asian people with type 2: What a 283-Participant Study Found

Saxagliptin added to metformin significantly improved blood sugar control and was well tolerated in Asian patients with T2DM who had inadequate blood sugar control with metformin and diet and lifestyle modification.

Diabetes research and clinical practice • 2011-11-15 • Randomized Controlled Trial
N = 283 93/100 PMID 21871686 ↗
Can This Approach Help? Inside the Latest Research on Safety, Growth, and Development After Dapagliflozin or Saxagliptin in Children

Prior treatment with dapagliflozin or saxagliptin for 52 weeks did not raise any safety concerns relating to height, weight, BMI, Tanner staging, growth and maturation markers, bone biomarkers, or AEs for up to 52 weeks...

The Journal of clinical endocrinology and metabolism • 2025-05-19 • Phase III Randomized Trial
Multi-cohort 88/100 PMID 39446459 ↗
Can This Approach Help? Inside the Latest Research on Dual add-on therapy in type 2 diabetes poorly controlled with metformin

In this first report of adding a well-tolerated combination of saxagliptin plus dapagliflozin to background metformin therapy in patients poorly controlled with metformin, greater improvements in blood sugar control were...

Diabetes care • 2015-03-15 • Phase III Randomized Trial
N = 176 88/100 PMID 25352655 ↗
Marcus Sterling (AI Healthcare Price Auditor)

Saxagliptin and Metformin Public Price Transparency Ledger

Neutral federal & cash pharmacy reference • RxCUI 1043563
Dispensing Channel / Benchmark Verification Source Reference Cost Details
Pharmacy Acquisition Cost (CMS NADAC) CMS Medicaid NADAC Weekly National Survey $9.3906/unit (~$281.72/30u) Wholesale baseline
Average U.S. Walk-In Retail Cash Price Chain Pharmacy Uninsured Cash Index $453.25 / mo Before coupon/insurance
Patient-Logged Out-of-Pocket Average 12 Anonymous DotMD Community Micro-Logs $185.00 / mo View logs ↓

Saxagliptin and Metformin Federal Verification & Benchmark Summary

Metric Verified Benchmark Source
Saxagliptin and Metformin RxNorm Concept ID 1043563 U.S. National Library of Medicine (RxNorm)
CMS NADAC Pharmacy Acquisition Unit Cost $9.3906 / unit CMS Medicaid NADAC Weekly Feed
Walk-In Chain Pharmacy Cash Average $453.25 / mo U.S. Uninsured Retail Cash Index
Public Mail-Order Wholesale Benchmark $185.00 / mo (Patient Mean) Public Cash Reference
Real-World Patient Consensus 87.00% Worth It (12 anonymous logs) DotMD Zero-PHI Patient Ledger
Zero-PHI Patient Community & 15-Second Dosage Logger

Saxagliptin and Metformin Patient Community, Cohort Filters & Dosage Logs

Cross-verified Saxagliptin and Metformin (biguanide) monograph synthesizing RxNorm 1043563, openFDA FAERS signals, and $185.00–$453.25 cash benchmarks.

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