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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01195259

Enrollment

Registered

2010-09-06

Start date

2009-10-31

Completion date

2010-01-31

Last updated

2013-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Keywords

rosiglitazone, ADOPT, metformin, malignancy, RECORD

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.

Interventions

DRUGallocation 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.

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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%.

Design outcomes

Primary

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026