Malignancy Meta Analysis for BRL49653

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Meta Analysis of Malignancy Serious Adverse Events in the ADOPT, 49653/048, and RECORD, 49653/231, Studies, Comparing Metformin With Rosiglitazone.

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: allocation of treatment with metformin or rosiglitazone


Participation Criteria
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Eligibility Criteria
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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%.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| metformin<br>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. | Drug: allocation of treatment with metformin or rosiglitazone<br>* 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.<br>|
| rosiglitazone<br>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. | Drug: allocation of treatment with metformin or rosiglitazone<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rosiglitazone, ADOPT, metformin, malignancy, RECORD