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Ahrén, B; Hirsch, IB; Pieber, TR; Mathieu, C; Gómez-Peralta, F; Hansen, TK; Philotheou, A; Birch, S; Christiansen, E; Jensen, TJ; Buse, JB; ADJUNCT TWO Investigators.
Efficacy and Safety of Liraglutide Added to Capped Insulin Treatment in Subjects With Type 1 Diabetes: The ADJUNCT TWO Randomized Trial.
Diabetes Care. 2016; 39(10):1693-1701
Doi: 10.2337/dc16-0690
[OPEN ACCESS]
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- Co-authors Med Uni Graz
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Pieber Thomas
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- Abstract:
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To investigate the efficacy and safety of liraglutide added to capped insulin doses in subjects with type 1 diabetes.
A 26-week, placebo-controlled, double-blind, parallel-group trial enrolling 835 subjects randomized 3:1 receiving once-daily subcutaneous liraglutide (1.8, 1.2, and 0.6 mg) or placebo added to an individually capped total daily dose of insulin.
Mean baseline glycated hemoglobin (HbA1c) (8.1% [65.0 mmol/mol]) was significantly decreased with liraglutide versus placebo at week 26 (1.8 mg: -0.33% [3.6 mmol/mol]; 1.2 mg: -0.22% [2.4 mmol/mol]; 0.6 mg: -0.23% [2.5 mmol/mol]; placebo: 0.01% [0.1 mmol/mol]). Liraglutide significantly reduced mean body weight (-5.1, -4.0, and -2.5 kg for 1.8, 1.2, and 0.6 mg, respectively) versus placebo (-0.2 kg). Significant reductions in daily insulin dose and increases in quality of life were seen with liraglutide versus placebo. There were higher rates of symptomatic hypoglycemia (21.3 vs. 16.6 events/patient/year; P = 0.03) with liraglutide 1.2 mg vs. placebo and of hyperglycemia with ketosis >1.5 mmol/L with liraglutide 1.8 mg vs. placebo (0.5 vs. 0.1 events/patient/year; P = 0.01).
In a broad population of subjects with long-standing type 1 diabetes, liraglutide added to capped insulin reduced HbA1c, body weight, and insulin requirements but with higher rates of hypoglycemia for liraglutide 1.2 mg and hyperglycemia with ketosis for liraglutide 1.8 mg.
© 2016 by the American Diabetes Association.
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Adolescent -
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Adult -
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Aged -
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Aged, 80 and over -
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Diabetes Mellitus, Type 1 - blood
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Diabetes Mellitus, Type 1 - drug therapy
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Double-Blind Method -
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Drug Therapy, Combination -
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Female -
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Glycated Hemoglobin A - analysis
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Humans -
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Hypoglycemic Agents - administration & dosage
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Injections, Subcutaneous -
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Insulin - administration & dosage
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Liraglutide - administration & dosage
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Male -
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Middle Aged -
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Treatment Outcome -
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Young Adult -