Efficacy and safety of liraglutide in type 1 diabetes by baseline characteristics in the ADJUNCT ONE and ADJUNCT TWO randomized controlled trials

Aim To evaluate 26 weeks of liraglutide treatment in type 1 diabetes (T1D) by subgroups in the ADJUNCT ONE and ADJUNCT TWO trials. Materials and Methods ADJUNCT ONE and ADJUNCT TWO were randomized controlled phase 3 trials in 1398 and 835 participants with T1D treated with liraglutide (1.8, 1.2, or...

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Published in:Diabetes, obesity & metabolism obesity & metabolism, 2021-12, Vol.23 (12), p.2752-2762
Main Authors: Dejgaard, Thomas F., von Scholten, Bernt J., Christiansen, Erik, Kreiner, Frederik F., Bardtrum, Lars, von Herrath, Matthias, Mathieu, Chantal, Madsbad, Sten
Format: Article
Language:English
Subjects:
Antidiabetics
Blood Glucose
Body mass index
Body weight
clinical trial
Diabetes
Diabetes mellitus (insulin dependent)
Diabetes Mellitus, Type 1 - drug therapy
GLP-1 receptor agonists
Glucagon
Glycated Hemoglobin A
Humans
Hyperglycemia
Hypoglycemia
Hypoglycemic Agents - therapeutic use
incretin therapy
Insulin
Ketosis
liraglutide
Liraglutide - therapeutic use
Original
Placebos
Randomized Controlled Trials as Topic
Treatment Outcome
type 1 diabetes
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Summary:Aim To evaluate 26 weeks of liraglutide treatment in type 1 diabetes (T1D) by subgroups in the ADJUNCT ONE and ADJUNCT TWO trials. Materials and Methods ADJUNCT ONE and ADJUNCT TWO were randomized controlled phase 3 trials in 1398 and 835 participants with T1D treated with liraglutide (1.8, 1.2, or 0.6 mg) or placebo (adjuncts to insulin). This post hoc analysis evaluated treatment effects by subgroups: HbA1c (< or ≥8.5%), body mass index (BMI; < or ≥27 kg/m2), and insulin regimen (basal bolus or continuous subcutaneous insulin infusion). Results In both trials at week 26, reductions in HbA1c, body weight, and daily insulin dose did not differ significantly (P > .05) by baseline HbA1c or BMI. Risk of clinically significant hypoglycaemia or hyperglycaemia with ketosis did not differ significantly (P > .05) by baseline HbA1c, BMI, or insulin regimen. At week 26 in ADJUNCT ONE, these risks did not differ (P > .05) between treatment groups. Placebo‐adjusted reductions in HbA1c, body weight, and insulin dose (−0.30%‐points, −5.0 kg, and −12%, respectively, with liraglutide 1.8 mg), were significant (P 
ISSN:1462-8902
1463-1326
DOI:10.1111/dom.14532