Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00131664
Status:
COMPLETED
Last Update Posted:
2013-04-17
First Post:
2005-08-17
Brief Title:
Avandia Amaryl or Avandamet Compared With Metformin AVALANCHE Study
Sponsor:
Canadian Heart Research Centre
Organization:
Canadian Heart Research Centre
Study Overview
Official Title:
Avandia Amaryl or Avandamet Compared With Metformin A 48-week Randomized Open-label Multicentre Phase IIIB Study to Compare the Effectiveness of Combination Therapy to Monotherapy in Type 2 Diabetes Mellitus Patients
Status:
COMPLETED
Status Verified Date:
2013-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AVALANCHE
Brief 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
Detailed Description:
AvandametTM combines two oral antihyperglycemic agents rosiglitazone maleate and metformin hydrochloride with different but complementary mechanisms of action to improve glycemic control while reducing circulating insulin levels in patients with type 2 diabetes AvandiaTM and AmarylTM combine two antidiabetic agents rosiglitazone maleate and glimepiride Glimepiride is an effective antihyperglycemic agent which has a low incidence of hypoglycemia symptomatic hypoglycemia severe hypoglycemia and confirmed hypoglycemia Subjects in this study who are inadequately controlled on diet exercise and a submaximal dose of metformin or sulfonylurea SU will be randomized to either a combination of metformin plus rosiglitazone AvandametTM or a combination of AvandiaTM AmarylTM or a Metformin monotherapy arm As per the Canadian Diabetes Association CDA guidelines their fasting plasma glucose and A1C to be 7 mmolL percent or less throughout the study If the subject does not achieve the target then either AvandametTM or AvandiaTM and AmarylTM or Metformin will be up-titrated in an effort to reach this CDA recommended target This study will attempt to demonstrate that the either combination arm of rosiglitazone plus metformin AvandametTM or the other combination arm of AvandiaTM AmarylTM will provide greater glycemic control while avoiding the side-effects associated with the use of maximal dose metformin
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None