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Efficacy and Safety of Liraglutide Added to Capped Insulin Treatment in Subjects With Type 1 Diabetes::The ADJUNCT TWO Randomized Trial
- Source :
- Ahrén, B, Hirsch, I B, Pieber, T R, Mathieu, C, Gómez-Peralta, F, Hansen, T K, Philotheou, A, Birch, S, Christiansen, E, Jensen, T J, Buse, J B & ADJUNCT TWO Investigators 2016, ' Efficacy and Safety of Liraglutide Added to Capped Insulin Treatment in Subjects With Type 1 Diabetes: The ADJUNCT TWO Randomized Trial ', Diabetes Care, vol. 39, no. 10, pp. 1693-701 . https://doi.org/10.2337/dc16-0690
- Publication Year :
- 2016
-
Abstract
- OBJECTIVE To investigate the efficacy and safety of liraglutide added to capped insulin doses in subjects with type 1 diabetes. RESEARCH DESIGN AND METHODS 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. RESULTS 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). CONCLUSIONS 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.
- Subjects :
- Adult
Male
medicine.medical_specialty
Adolescent
Injections, Subcutaneous
Endocrinology, Diabetes and Metabolism
medicine.medical_treatment
Population
030209 endocrinology & metabolism
030204 cardiovascular system & hematology
Hypoglycemia
Placebo
Young Adult
03 medical and health sciences
chemistry.chemical_compound
0302 clinical medicine
Double-Blind Method
Internal medicine
Diabetes mellitus
Internal Medicine
medicine
Journal Article
Humans
Hypoglycemic Agents
Insulin
education
Aged
Aged, 80 and over
Glycated Hemoglobin
Advanced and Specialized Nursing
education.field_of_study
Type 1 diabetes
business.industry
Liraglutide
Middle Aged
medicine.disease
Diabetes Mellitus, Type 1
Treatment Outcome
Endocrinology
chemistry
Drug Therapy, Combination
Female
Glycated hemoglobin
business
medicine.drug
Subjects
Details
- Language :
- English
- Database :
- OpenAIRE
- Journal :
- Ahrén, B, Hirsch, I B, Pieber, T R, Mathieu, C, Gómez-Peralta, F, Hansen, T K, Philotheou, A, Birch, S, Christiansen, E, Jensen, T J, Buse, J B & ADJUNCT TWO Investigators 2016, ' Efficacy and Safety of Liraglutide Added to Capped Insulin Treatment in Subjects With Type 1 Diabetes: The ADJUNCT TWO Randomized Trial ', Diabetes Care, vol. 39, no. 10, pp. 1693-701 . https://doi.org/10.2337/dc16-0690
- Accession number :
- edsair.doi.dedup.....48651c741a7c80f5516dfaec33f7f5d1