SCALE-PREDIABETES — 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. Prediabetes and progression to type 2 diabetes · Obesity and overweight in adults

Glucose regulation impaired beyond normal limits but below diagnostic thresholds for diabetes, including impaired fasting glucose, impaired glucose tolerance, and intermediate HbA1c.

Geographic footprint. Norway · Finland · Belgium · Italy · Poland · Hungary · Japan · Republic of Korea · Argentina · India · China.

§2.4Eligibility as the Institute reads it

• Included. Glucose regulation impaired beyond normal limits but below diagnostic thresholds for diabetes, including impaired fasting glucose, impaired glucose tolerance, and intermediate HbA1c.
• Excluded. Participants for whom the intervention is contraindicated, including personal or family history of medullary thyroid carcinoma. 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.