AVANDAMET

LOE Approaching

metformin hydrochloride; rosiglitazone maleate

NDAORALTABLET
Approved
Oct 2002
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
7

Mechanism of Action

AVANDAMET: AVANDAMET combines 2 antidiabetic agents with different mechanisms of action to improve glycemic control in patients with type 2 diabetes: Rosiglitazone, a member of the thiazolidinedione class, and metformin, a member of the biguanide class. Thiazolidinediones are insulin sensitizing…

Indications (7)

type 2 diabetes mellitusnot already taking rosiglitazoneunable to achieve glycemic control on other diabetes medications andconsultation with their healthcare providerpioglitazone-containing products (ACTOPLUS METACTOPLUS MET XRDUETACT) for medical reasons

Clinical Trials (5)

NCT01332071Phase 1Completed

Avandamet Bioequivalence Study Brazil - Fed Administration

Started Nov 2009
26 enrolled
Diabetes Mellitus, Type 2
NCT00386100Phase 4Completed

A Type 2 Diabetes Study of the Longer-Term Glycemic Effect of AVANDAMET vs. Metformin

Started Oct 2006
688 enrolled
Diabetes Mellitus, Type 2
NCT00131664Phase 3Completed

Avandia™ + Amaryl™ or Avandamet™ Compared With Metformin (AVALANCHE™ Study)

Started Sep 2005
391 enrolled
Type 2 Diabetes Mellitus
NCT01294553N/ACompleted

An Open Label, Multi-centre, Non-interventional Post-marketing Surveillance to Monitor the Safety and/or Efficacy of AVANDAMET Between June 2004 and January 2010

Started Jun 2004
717 enrolled
Diabetes Mellitus, Type 2
NCT00359112Phase 3Completed

AVANDAMET Versus Metformin And Sulphonylurea In People With Poorly Controlled Type 2 Diabetes

Started Feb 2004
544 enrolled
Non-Insulin-Dependent Diabetes Mellitus
External Resources
DailyMed
Full prescribing information
FDA Drugs@FDA
FDA approval history
RxNorm
Drug nomenclature & identifiers