REDEFINE-2 — design and population

§2Design and population

§2.1Design and allocation

Design class

Randomised, double-blind, placebo-controlled, parallel-group

Masking

Double-blind (participant, investigator and sponsor)

Arms

2

Allocation

Randomised between the intervention and its comparator

Endpoint adjudication

Not applicable to the primary endpoint of this design

Data monitoring

As specified in the protocol

§2.2Arms

Table 2. Randomised arms. Illustrative: arm-level allocations are reconstructed by the Institute from the design class and the randomised total where the published report does not state them.

§2.3Population

Indications. Obesity and overweight in adults · Type 2 diabetes mellitus

Excess adiposity sufficient to impair health, operationalised in the pivotal incretin programmes as a body-mass index of 30 kg/m² or above, or 27 kg/m² or above with at least one weight-related comorbidity.

Geographic footprint. Canada · Denmark · Belgium · Italy · Poland · Israel · Taiwan · Australia · South Africa.

§2.4Eligibility as the Institute reads it

• Included. Excess adiposity sufficient to impair health, operationalised in the pivotal incretin programmes as a body-mass index of 30 kg/m² or above, or 27 kg/m² or above with at least one weight-related comorbidity.
• Excluded. Participants for whom the intervention is contraindicated, including as for each component. Exclusion criteria narrow the population to which the estimate applies and are the principal source of indirectness where a trial estimate is applied to ordinary practice.