NDAORALTABLET, EXTENDED RELEASE
Approved
Jun 2005
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
5/8 — Partial
GLUMETZA (metformin hydrochloride) by Teva is 2 diabetes, lowering both basal and postprandial plasma glucose. First approved in 2005.
Drug data last refreshed 22m ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
GLUMETZA is an extended-release oral tablet formulation of metformin hydrochloride approved in 2005 for type 2 diabetes management. It lowers blood glucose by decreasing hepatic glucose production, reducing intestinal glucose absorption, and improving insulin sensitivity through increased peripheral glucose uptake. Metformin maintains unchanged insulin secretion while reducing fasting insulin levels and day-long plasma insulin response.
$38MPart D
LOE ApproachingWith LOE approaching and $38M in Part D spending, the GLUMETZA brand team is likely in optimization and defensive mode, focused on retention and cost-efficiency rather than growth expansion.
Mechanism of Action
2 diabetes, lowering both basal and postprandial plasma glucose. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization. With metformin therapy, insulin secretion remains…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Pharmacokinetics and Bioequivalence Study of Empagliflozin+Metformin Hydrochloride 12.5 mg/1000 mg Film-coated Tablets (Gedeon Richter Plc., Hungary) Versus Synjardy 12.5 mg/1000 mg Film-coated Tablets (Boehringer Ingelheim International GmbH, Germany)
Started May 2025
64 enrolled
Diabetes Mellitus Type 2
Pharmacokinetics and Bioequivalence Study of Empagliflozin+Metformin Hydrochloride 5 mg/1000 mg Film-coated Tablets (Gedeon Richter Plc., Hungary) Versus Synjardy 5 mg/1000 mg Film-coated Tablets (Boehringer Ingelheim International GmbH, Germany)
Started Mar 2025
64 enrolled
Diabetes Mellitus Type 2
Pharmacokinetics and Bioequivalence Study of Empagliflozin+Metformin Hydrochloride 5 mg/850 mg Film-coated Tablets (Gedeon Richter Plc., Hungary) Versus Synjardy® 5 mg/850 mg Film-coated Tablets (Boehringer Ingelheim International GmbH, Germany)
Started Jan 2025
64 enrolled
Diabetes Mellitus Type 2
Sitagliptin and Metformin Hydrochloride Tablets 50 mg/500 mg Relative to Originator
Started Jun 2024
34 enrolled
Healthy Subjects
Sitagliptin and Metformin Hydrochloride Tablets 50 mg/1000 mg Relative to Originator
Started Apr 2024
34 enrolled
Healthy Subjects
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.