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DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE (DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE)
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE (generic name: DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE) is a drug developed by AUROBINDO PHARMA LIMITED. It is currently FDA-approved.
Dapagliflozin and metformin hydrochloride are used to treat type 2 diabetes mellitus, as well as the prediabetic state. They are also being studied in combination with exercise for their effects on glucose variability, body composition, and cardiovascular health in individuals with pre-diabetes.
At a glance
| Generic name | DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE |
|---|---|
| Sponsor | AUROBINDO PHARMA LIMITED |
| Therapeutic area | Other |
| Phase | FDA-approved |
Approved indications
Common side effects
- Diarrhea
- Nausea/Vomiting
Serious adverse events
- Renal impairment
- Increased blood creatinine
- Decreased renal creatinine clearance
- Urinary tract infection
Key clinical trials
- A Multicenter, Randomized, Double-Blind, Active Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin 10 mg in Combination With Metformin as Initial Therapy as (Phase 3)
- A 16-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Safety and Efficacy of Dapagliflozin 2.5 mg BID, 5 mg BID and 10 mg QD Versus Placebo in Patients W (Phase 3)
- Effect of Sodium Glucose Cotransporter-2 Inhibitors on Metabolic, Hormonal and Clinical Parameters in Infertile Women With Polycystic Ovary Syndrome (Phase 3)
- Effect of Dapagliflozin vs Sitagliptin on Liver Fat Accumulation and Body Composition in Patients With Diabetes Mellitus and Liver Transplantation: a Randomized Controlled Trial (NA)
- Efficacy of Dapagliflozin in Diabetes Associated Peripheral Neuropathy: A Randomized Placebo Controlled Trial (Phase 2)
- A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of Pioglitazone 15mg or Pioglitazone 30mg Add-on in Patients With Type 2 Diabetes Melli (Phase 3)
- An Open-label, 2-arm, Single-sequence, Fed, Single Oral Dosing, Crossover Clinical Trial to Evaluate Safety and the Pharmacokinetics Between Dapagliflozin, Linagliptin and Metformin in Healthy Adult S (Phase 1)
- Assessment of the Renin-angiotensin-aldosterone System (RAAS) and Antidiuretic Function in Patients With Type 2 Diabetes Before and During Treatment With Sodium-glucose Co-transporter 2 Inhibitors (SG (NA)
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:
- DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE CI brief — competitive landscape report
- DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE updates RSS · CI watch RSS
- AUROBINDO PHARMA LIMITED portfolio CI
Frequently asked questions about DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
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Related
- Manufacturer: AUROBINDO PHARMA LIMITED — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing