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Saxagliptin-Metformin XR
Saxagliptin inhibits DPP-4 to increase incretin levels and lower blood glucose, while metformin XR reduces hepatic glucose production and improves insulin sensitivity.
Saxagliptin inhibits DPP-4 to increase incretin levels and lower blood glucose, while metformin XR reduces hepatic glucose production and improves insulin sensitivity. Used for Type 2 diabetes mellitus.
At a glance
| Generic name | Saxagliptin-Metformin XR |
|---|---|
| Also known as | Kombiglyze XR, Combination DPP-4 inhibitor and Glucophage XR |
| Sponsor | Woman's |
| Drug class | DPP-4 inhibitor / Biguanide combination |
| Target | DPP-4 enzyme; metformin targets mitochondrial glycerophosphate dehydrogenase and AMPK |
| Modality | Small molecule |
| Therapeutic area | Diabetes |
| Phase | Phase 3 |
Mechanism of action
Saxagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor that prolongs the action of incretin hormones (GLP-1 and GIP), which stimulate insulin secretion in response to meals. Metformin XR is a biguanide that decreases hepatic gluconeogenesis and improves peripheral insulin sensitivity. Together, they provide complementary glucose-lowering effects through different mechanisms.
Approved indications
- Type 2 diabetes mellitus
Common side effects
- Hypoglycemia
- Gastrointestinal disturbance (nausea, diarrhea, abdominal pain)
- Headache
- Nasopharyngitis
- Lactic acidosis (rare, metformin-associated)
Key clinical trials
- Outpatient Discharge Therapy With Saxagliptin+MetforminXR vs GlipizideXL for Type 2 Diabetes With Severe Hyperglycemia (PHASE4)
- Bioequivalence Study of Combination Tablets of Saxagliptin / Dapagliflozin / Metformin XR (Extended-release) and Dapagliflozin / Metformin XR Relative to Individual Components in Healthy Subjects (PHASE1)
- A Study to Evaluate the Food Effect on Drug Availability, Pharmacokinetic (PK) Properties, Safety and Tolerability of Two Different Dose Combination Therapy of Saxagliptin/Dapagliflozin/Metformin Extended-release (XR) Against Individual Component Co-administration. (PHASE1)
- Korean Post-marketing Surveillance for Kombiglyze XR®
- Saxagliptin + Metformin Compared to Saxagliptin or Metformin Monotherapy in PCOS Women With Impaired Glucose Homeostasis (PHASE3)
- Safety and Efficacy of Combination Saxagliptin & Dapagliflozin Added to Metformin to Treat Subjects With Type 2 Diabetes (PHASE3)
- A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Saxagliptin (BMS-477118) in Combination With Metformin IR or Metformin XR in Pediatric Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone (PHASE3)
- Study of Saxagliptin, 5-Hydroxy Saxagliptin, and Metformin Concentrations/Levels in Pediatric Subjects With T2DM (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:
- Saxagliptin-Metformin XR CI brief — competitive landscape report
- Saxagliptin-Metformin XR updates RSS · CI watch RSS
- Woman's portfolio CI