The quality of evidence is downgraded by suspected publication bias (commercially funded study).
A 56-week randomized, double-blind, placebo-controlled, trial 1 with 12-week observational off-drug follow-up period included 846 subjects with diabetes type 2, and was conducted at 126 sites in 9 countries. Patients taking 0 to 3 oral hypoglycemic agents (metformin, thiazolidinedione, sulfonylurea) with stable body weight (BMI 27.0 or greater, mean weight 106 kg) and glycated hemoglobin level 7.0% to 10.0% were receiving once-daily, subcutaneous liraglutide 3.0 mg (n = 423), liraglutide 1.8 mg (n = 211), or placebo (n = 212), all as adjunct to 500 kcal/d dietary deficit and increased physical activity (at least 150 min/wk). Weight loss was significantly greater in patients with liraglutide than with placebo (table T1), mean difference was 4 % at one year with liraglutide 3.0 mg compared with placebo. More gastrointestinal disorders were reported with liraglutide (3.0 mg) vs liraglutide (1.8 mg) and placebo. No pancreatitis was reported.
In another randomised, double-blind, placebo-controlled commercially funded trial 2, adults with prediabetes (BMI of at least 30, or at least 27 with comorbidities), were randomised to once-daily subcutaneous liraglutide 3.0 mg (n= 1505) or placebo (n=749), as an adjunct to a reduced-calorie diet and increased physical activity. 50% participants completed the study up to week 160, after withdrawal of 47% participants in the liraglutide group and 55% participants in the placebo group. By week 160, 26 (2%) of 1472 individuals in the liraglutide group versus 46 (6%) of 738 in the placebo group were diagnosed with diabetes (primary outcome) while on treatment (hazard ratio of 0.021, 95% CI 0.13 to 0.34). Liraglutide induced greater weight loss than placebo at week 160 (-6.01 [SD 7.3] vs -1.9% [6.3]; estimated treatment difference -4.3%, 95% CI -4.9 to -3.7, p<0.0001).
| Outcome | Liraglutide 3.0 mg | Estimated difference for liraglutide 3.0 mg vs placebo (95% CI) | Liraglutide 1.8 mg | Estimated difference for liraglutide 1.8 mg vs placebo (95% CI) | Placebo |
|---|---|---|---|---|---|
| Mean weight loss | 6.0% (6.4 kg) | -4.00% (-5.10% to -2.90%) | 4.7% (5.0 kg) | -2.71% (-4.00% to -1.42%) | 2.0% (2.2 kg) |
| Weight loss of 5% or greater, in percentage of patients | 54.3% of patients | 32.9% (24.6% to 41.2%) | 40.4% of patients | 19.0% (9.1% to 28.8%) | 21.4% of patients |
| Weight loss of 10% or greater, in percentage of patients | 25.2% of patients | 18.5% (12.7% to 24.4%) | 15.9% of patients | 9.3% (2.7% to 15.8%) | 6.7% of patients |
In another randomised, double-blind, placebo-controlled trial 3 711 patients with T2D on a stable dose of metformin (HASH(0x2fcfe80)1500 mg or maximum tolerated) with or without a sodium-glucose co-transporter-2 inhibitor. were assigned to once-daily oral semaglutide (dose escalated to 14 mg), once-daily subcutaneous liraglutide (dose escalated to 1.8 mg), or placebo for 52 weeks. Mean change from baseline in HbA1c at week 26 was -1.2% with oral semaglutide, -1.1% with subcutaneous liraglutide, and -0.2% with placebo. Oral semaglutide resulted in better weight loss (-4.4 kg) compared with liraglutide (-3.1 kg) and placebo (-0.5 kg) at week 26. Estimand, weight loss at week 26 was significantly greater with oral semaglutide than with subcutaneous liraglutide (-1.5 kg, 95% CI -2.2 to -0.9; p<0.0001) and placebo (ETD -4.0 kg, -4.8 to -3.2; p<0.0001).
Another randomised, double-blind, placebo-controlled trial 4 included 1961 adults with a body-mass index HASH(0x2fcfe80)30 without diabetes. The change in body weight from baseline to week 68 was -15.3 kg in the semaglutide group as compared with -2.6 kg in the placebo group (estimated treatment difference, -12.7 kg; 95% CI -13.7 to -11.7), being respective for -14.9% in the semaglutide group as compared with -2.4% with placebo, for an estimated treatment difference of -12.4 percentage points (95% CI -13.4 to -11.5).
Date of latest search: 2024-01-09
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