drugset / Trial / NCT00131664

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

NCT00131664

RandomizedParallel-groupOpen-labelTreatment

Summary

The incidence of type 2 diabetes is on the increase. According to recent Canadian Diabetes Association guidelines glucose control, based on the A1C measurement, needs to be achieved within a 6-12 month period of time after the initial diagnosis of type 2 diabetes. The guidelines on the use of antihyperglycemic agents identify the potential benefits of sub-maximal oral combination therapy in order to achieve more rapid and improved glycemic control compared with higher dose monotherapy. Furthermore, many patients on prolonged oral antihyperglycemic monotherapy who then start on combination therapy may not achieve the required target glycemic control. Indeed early initiation of combination therapies may be necessary to achieve and maintain glycemic targets because of the progressive deterioration of pancreatic β cell function and glycemic control.

Timeline

Start
2005-09
Primary completion
2008-01
Completion
2008-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Avandamet Unknown 4 mg Oral
Comparator Avandamet Unknown 1000 mg Oral
Comparator Glimepiride Small molecule 2 mg
Comparator Metformin Small molecule 1000 mg
Comparator Rosiglitazone Small molecule 8 mg