Ignite Creation Date:
2024-05-05 @ 5:05 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00386100
Status:
COMPLETED
Last Update Posted:
2016-11-23
First Post:
2006-10-09
Brief Title:
A Type 2 Diabetes Study of the Longer-Term Glycemic Effect of AVANDAMET vs Metformin
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Randomized Parallel Group Double-blind Multi-center Study Comparing the Efficacy and Safety of AVANDAMET and Metformin After 80 Weeks of Treatment
Status:
COMPLETED
Status Verified Date:
2016-10
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:
None
Brief Summary:
This study will evaluate the longer-term glycemic effect of two medicines approved for initial treatment of type 2 diabetes The study consists of a 2 week screening period 2 study visits followed by an 80 week double-blind treatment period 11 study visits Also a sub-study was included to look at changes in bone mineral density BMD at the lumbar spine
Detailed Description:
This was a phase IV randomized double-blind global multi-centre study The study consisted of a 2 week screening period followed by an 80 week double-blind treatment period Subjects who met all eligibility requirements were randomized in a 11 ratio stratified by country gender male and female and pre-screening HbA1c 9 or9 either to MET or AVM When the substudy was added a new randomization was created for the participating centers Those subjects in the bone sub-study were stratified by country gender male premenopausal female and postmenopausal female pre-screening HbA1c ie 9 9 and either to MET or AVM
At randomization Visit 3 Week 0 subjects were initiated at Dose Level 1 Treatment with AVM was initiated at a dose of 4 mg500 mg and titrated up to a maximum total daily dose of AVM 8 mg2000 mg Treatment with MET therapy was initiated at a dose of 500 mg and titrated up to a maximum daily dose of 2000mg
At randomization Visit 3 Week 0 subjects were initiated at Dose Level 1 Treatment with AVM was initiated at a dose of 4 mg500 mg and titrated up to a maximum total daily dose of AVM 8 mg2000 mg Treatment with MET therapy was initiated at a dose of 500 mg and titrated up to a maximum daily dose of 2000mg
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