Malignancy Meta Analysis for BRL49653

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: allocation of treatment with metformin or rosiglitazone

• Registration Number: NCT01195259
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2009-10
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Study First Submitted: 2010-09-01
• Study First Submitted QC: 2010-09-02
• Study First Posted: 2010-09-06
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-24
• Last Update Posted: 2013-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
metformin	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.
rosiglitazone	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.

Primary Outcome Measures

Name	Time	Method
Time to first occurrence of a serious adverse event of malignancy (excluding non-melanomatous skin cancers)	ADOPT approximately 4 years duration, RECORD approximately 5.5 years duration