STEP trial programme: difference between revisions
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| 11 | STEP 1, the largest and most cited, randomised 1,961 adults with obesity and without diabetes to semaglutide 2.4 mg or placebo for 68 weeks, both arms receiving lifestyle intervention. Mean weight change was −14.9% on active treatment and −2.4% on placebo.{{r|wilding2021}} | 11 | STEP 1, the largest and most cited, randomised 1,961 adults with obesity and without diabetes to semaglutide 2.4 mg or placebo for 68 weeks, both arms receiving lifestyle intervention. Mean weight change was −14.9% on active treatment and −2.4% on placebo.{{r|wilding2021}} |
| 12 | 12 | ||
| + | 13 | == The constituent trials == | |
| + | 14 | | Trial | Population | Comparison | Weight change, active vs comparator | | |
| + | 15 | |---|---|---|---| | |
| + | 16 | | STEP 1 | Obesity, no diabetes | Placebo | −14.9% vs −2.4% | | |
| + | 17 | | STEP 2 | Obesity with type 2 diabetes | Placebo and 1.0 mg | −9.6% vs −3.4% | | |
| + | 18 | | STEP 3 | Obesity, intensive behavioural therapy | Placebo | −16.0% vs −5.7% | | |
| + | 19 | | STEP 4 | Randomised withdrawal after run-in | Continue vs switch to placebo | Continued loss vs regain | | |
| + | 20 | | STEP 8 | Obesity, no diabetes | [[Liraglutide]] 3.0 mg | −15.8% vs −6.4% | | |
| + | 21 | ||
| + | 22 | STEP 2 illustrates a consistent finding in this field: weight response is attenuated in people with type 2 diabetes, for reasons that are not established. STEP 3 shows that intensive behavioural support raises both arms rather than only the placebo arm.{{r|davies2021}} | |
| + | 23 | ||
| 13 | == References == | 24 | == References == |
| 14 | {{reflist}} | 25 | {{reflist}} |
| 15 | <ref name="wilding2021">Wilding JPH, Batterham RL, Calanna S, et al. "Once-weekly semaglutide in adults with overweight or obesity." ''New England Journal of Medicine'' 384(11):989–1002 (2021). DOI:10.1056/NEJMoa2032183. PMID 33567185.</ref> | 26 | <ref name="wilding2021">Wilding JPH, Batterham RL, Calanna S, et al. "Once-weekly semaglutide in adults with overweight or obesity." ''New England Journal of Medicine'' 384(11):989–1002 (2021). DOI:10.1056/NEJMoa2032183. PMID 33567185.</ref> |
| + | 27 | <ref name="davies2021">Davies M, Færch L, Jeppesen OK, et al. "Semaglutide 2.4 mg once a week in adults with overweight or obesity, and type 2 diabetes (STEP 2)." ''The Lancet'' 397(10278):971–984 (2021). PMID 33667417.</ref> | |
| 16 | 28 | ||
| 17 | {{DEFAULTSORT:STEP trial programme}} | 29 | {{DEFAULTSORT:STEP trial programme}} |