Efficacy and Safety of Liraglutide Added to Capped Insulin Treatment in Subjects With Type 1 Diabetes: The ADJUNCT TWO Randomized Trial

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 placeb...

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Bibliographic Details
Published inDiabetes care Vol. 39; no. 10; pp. 1693 - 1701
Main Authors Ahrén, Bo, Hirsch, Irl B., Pieber, Thomas R., Mathieu, Chantal, Gómez-Peralta, Fernando, Hansen, Troels Krarup, Philotheou, Areti, Birch, Sune, Christiansen, Erik, Jensen, Thomas Jon, Buse, John B.
Format Journal Article
LanguageEnglish
Published United States American Diabetes Association 01.10.2016
Subjects
Adolescent
Adult
Aged
Aged, 80 and over
Clinical Medicine
Clinical trials
Diabetes
Diabetes Mellitus, Type 1 - blood
Diabetes Mellitus, Type 1 - drug therapy
Double-Blind Method
Drug dosages
Drug Therapy, Combination
Endocrinology and Diabetes
Endokrinologi och diabetes
Female
Glycated Hemoglobin A - analysis
Humans
Hyperglycemia
Hypoglycemia
Hypoglycemic Agents - administration & dosage
Injections, Subcutaneous
Insulin
Insulin - administration & dosage
Klinisk medicin
Liraglutide - administration & dosage
Male
Medical and Health Sciences
Medicin och hälsovetenskap
Middle Aged
Placebo effect
Treatment Outcome
Young Adult
Online AccessGet full text

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Abstract 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.
AbstractList 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% [3.6mmol/mol]; 1.2mg: -0.22% [2.4mmol/mol]; 0.6 mg: -0.23% [2.5mmol/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 1.2mg vs. placebo and of hyperglycemia with ketosis >1.5mmol/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.
To investigate the efficacy and safety of liraglutide added to capped insulin doses in subjects with type 1 diabetes.OBJECTIVETo 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.RESEARCH DESIGN AND METHODSA 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).RESULTSMean 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.CONCLUSIONSIn 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.
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.
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 HbA^sub 1c^, 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.
Author Buse, John B.
Christiansen, Erik
Philotheou, Areti
Birch, Sune
Pieber, Thomas R.
Mathieu, Chantal
Hirsch, Irl B.
Hansen, Troels Krarup
Ahrén, Bo
Jensen, Thomas Jon
Gómez-Peralta, Fernando
Author_xml – sequence: 1
  givenname: Bo
  surname: Ahrén
  fullname: Ahrén, Bo
  organization: Lund University, Lund, Sweden
– sequence: 2
  givenname: Irl B.
  surname: Hirsch
  fullname: Hirsch, Irl B.
  organization: University of Washington, Seattle, WA
– sequence: 3
  givenname: Thomas R.
  surname: Pieber
  fullname: Pieber, Thomas R.
  organization: Medical University of Graz, Graz, Austria
– sequence: 4
  givenname: Chantal
  surname: Mathieu
  fullname: Mathieu, Chantal
  organization: University of Leuven, Leuven, Belgium
– sequence: 5
  givenname: Fernando
  surname: Gómez-Peralta
  fullname: Gómez-Peralta, Fernando
  organization: Hospital General de Segovia, Segovia, Spain
– sequence: 6
  givenname: Troels Krarup
  surname: Hansen
  fullname: Hansen, Troels Krarup
  organization: Aarhus University Hospital, Aarhus, Denmark
– sequence: 7
  givenname: Areti
  surname: Philotheou
  fullname: Philotheou, Areti
  organization: University of Cape Town Private Academic Hospital, Cape Town, South Africa
– sequence: 8
  givenname: Sune
  surname: Birch
  fullname: Birch, Sune
  organization: Novo Nordisk A/S, Bagsvaerd, Denmark
– sequence: 9
  givenname: Erik
  surname: Christiansen
  fullname: Christiansen, Erik
  organization: Novo Nordisk A/S, Bagsvaerd, Denmark
– sequence: 10
  givenname: Thomas Jon
  surname: Jensen
  fullname: Jensen, Thomas Jon
  organization: Novo Nordisk A/S, Bagsvaerd, Denmark
– sequence: 11
  givenname: John B.
  surname: Buse
  fullname: Buse, John B.
  organization: University of North Carolina School of Medicine, Chapel Hill, NC
BackLink https://www.ncbi.nlm.nih.gov/pubmed/27493132$$D View this record in MEDLINE/PubMed
https://lup.lub.lu.se/record/71302492-0734-4f10-8be1-cc66ccce763e$$DView record from Swedish Publication Index
oai:portal.research.lu.se:publications/71302492-0734-4f10-8be1-cc66ccce763e$$DView record from Swedish Publication Index
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ContentType Journal Article
Copyright 2016 by the American Diabetes Association.
Copyright American Diabetes Association Oct 1, 2016
Copyright_xml – notice: 2016 by the American Diabetes Association.
– notice: Copyright American Diabetes Association Oct 1, 2016
CorporateAuthor for the ADJUNCT TWO Investigators
ADJUNCT TWO Investigators
Medicin/akutsjukvård, Lund
Institutionen för kliniska vetenskaper, Lund
Sektion II
Section II
Lunds universitet
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Snippet To investigate the efficacy and safety of liraglutide added to capped insulin doses in subjects with type 1 diabetes. A 26-week, placebo-controlled,...
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...
To investigate the efficacy and safety of liraglutide added to capped insulin doses in subjects with type 1 diabetes.OBJECTIVETo investigate the efficacy and...
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...
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StartPage 1693
SubjectTerms Adolescent
Adult
Aged
Aged, 80 and over
Clinical Medicine
Clinical trials
Diabetes
Diabetes Mellitus, Type 1 - blood
Diabetes Mellitus, Type 1 - drug therapy
Double-Blind Method
Drug dosages
Drug Therapy, Combination
Endocrinology and Diabetes
Endokrinologi och diabetes
Female
Glycated Hemoglobin A - analysis
Humans
Hyperglycemia
Hypoglycemia
Hypoglycemic Agents - administration & dosage
Injections, Subcutaneous
Insulin
Insulin - administration & dosage
Klinisk medicin
Liraglutide - administration & dosage
Male
Medical and Health Sciences
Medicin och hälsovetenskap
Middle Aged
Placebo effect
Treatment Outcome
Young Adult
Title Efficacy and Safety of Liraglutide Added to Capped Insulin Treatment in Subjects With Type 1 Diabetes: The ADJUNCT TWO Randomized Trial
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Volume 39
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