A Meta Analysis of Malignancy Serious Adverse Events in the ADOPT, 49653/048, and RECORD, 49653/231, Studies, Comparing Metformin With Rosiglitazone.
N/A
N/A
Both
Diabetes Mellitus, Type 2
Trial Information
A Meta Analysis of Malignancy Serious Adverse Events in the ADOPT, 49653/048, and RECORD, 49653/231, Studies, Comparing Metformin With Rosiglitazone.
The objective of this meta-analysis is to compare the incidence of malignancy (excluding
non-melanomatous skin cancers) reported as serious adverse events in the ADOPT and RECORD
studies between subjects randomly allocated to treatment with metformin with those allocated
to rosiglitazone.
Inclusion Criteria
Subjects from ADOPT that are included in this meta-analysis (those in the metformin or
rosiglitazone groups) had the dose of their study medication increased to a maximum of 2g
(metformin) or 8mg (rosiglitazone) if their fasting plasma glucose was greater than
140mg/dl.
Subjects from RECORD that are included in this meta-analsyis entered the RECORD study
taking one of three sulfonylureas (glibenclamide, gliclazide or glimepiride). They were
randomly allocated to metformin or rosiglitazone in a 1:1 ration to use as add-on
treatment to the background of sulfonylurea. These subjects had the dose of their study
medication increased to a maximum of 2.55g (metformin) or 8mg (rosiglitazone) if their
HbA1c was greater than 7.0%.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
Outcome Measure:
Time to first occurrence of a serious adverse event of malignancy (excluding non-melanomatous skin cancers)
Outcome Time Frame:
ADOPT approximately 4 years duration, RECORD approximately 5.5 years duration
Safety Issue:
No
Principal Investigator
GSK Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
GlaxoSmithKline
Authority:
United Kingdom: No Health Authority
Study ID:
114769
NCT ID:
NCT01195259
Start Date:
October 2009
Completion Date:
January 2010
Related Keywords:
- Diabetes Mellitus, Type 2
- rosiglitazone
- ADOPT
- metformin
- malignancy
- RECORD
- Neoplasms
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
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