Malignancy Meta Analysis for BRL49653

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01195259
First received: September 1, 2010
Last updated: October 24, 2013
Last verified: October 2013

September 1, 2010
October 24, 2013
October 2009
January 2010   (final data collection date for primary outcome measure)
Time to first occurrence of a serious adverse event of malignancy (excluding non-melanomatous skin cancers) [ Time Frame: ADOPT approximately 4 years duration, RECORD approximately 5.5 years duration ] [ Designated as safety issue: No ]
Time to first occurrence of a serious adverse event of malignancy (excluding non-melanomatous skin cancers [ Time Frame: ADOPT approximately 4 years duration, RECORD approximately 5.5 years duration ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01195259 on ClinicalTrials.gov Archive Site
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Malignancy Meta Analysis for BRL49653
A Meta Analysis of Malignancy Serious Adverse Events in the ADOPT, 49653/048, and RECORD, 49653/231, Studies, Comparing Metformin With Rosiglitazone.

Observational analyses of data from population registeries have suggested that metformin may be associated with a decreased prevalence of malignancy. The ADOPT and RECORD studies both contain groups of subjects randomly allocated to metformin and rosiglitazone. This meta-analysis combines malignancy serious adverse events from ADOPT and RECORD in order to compare their incidence on metformin with that on 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.

Observational
Observational Model: Cohort
Time Perspective: Retrospective
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Probability Sample

5135 subjects with type 2 diabetes mellitus from the intention to treat (ITT) populations of 2 randomised, controlled studies (2576 metformin/2559 rosiglitazone)

Diabetes Mellitus, Type 2
Drug: allocation of treatment with metformin or rosiglitazone
Subjects from ADOPT that are included in this meta-analysis were randomly allocated to receive metformin or rosiglitazone. Subjects from RECORD that are included in this meta-analysis were taking one of three sulfonylureas (glibenclamide, gliclazide or glimepiride) and were randomly allocated metformin or rosiglitazone to use as add-on treament to background sulfonylurea.
  • metformin
    Subjects from ADOPT that are included in this meta-analysis were randomly allocated to receive metformin or rosiglitazone. Subjects from RECORD that are included in this meta-analysis were taking one of three sulfonylureas (glibenclamide, gliclazide or glimepiride) and were randomly allocated metformin or rosiglitazone to use as add-on treament to background sulfonylurea.
    Intervention: Drug: allocation of treatment with metformin or rosiglitazone
  • rosiglitazone
    Subjects from ADOPT that are included in this meta-analysis were randomly allocated to receive metformin or rosiglitazone. Subjects from RECORD that are included in this meta-analysis were taking one of three sulfonylureas (glibenclamide, gliclazide or glimepiride) and were randomly allocated metformin or rosiglitazone to use as add-on treament to background sulfonylurea.
    Intervention: Drug: allocation of treatment with metformin or rosiglitazone
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1
January 2010
January 2010   (final data collection date for primary outcome measure)

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%.

Both
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No
Contact information is only displayed when the study is recruiting subjects
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NCT01195259
114769
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP