title: Design and methods of a randomised double-blind trial of adding liraglutide to control HbA1c in patients with type 2 diabetes with impaired glycaemic control treated with multiple daily insulin injections (MDI-Liraglutide trial).
abstract: OBJECTIVE
  Patients with type 2 diabetes are generally treated in primary care setting and as a final treatment step to obtain good glycaemic control, multiple daily insulin injections (MDI) are generally used. The aim of this study is to evaluate the effect of GLP-1 analogue liraglutide on glycaemic control in patients with type 2 diabetes treated with MDI with inadequate glycaemic control.
  
  
  METHODS
  Overweight and obese patients with type 2 diabetes and impaired glycaemic control treated with MDI were randomised to liraglutide or placebo over 24 weeks. Masked continuous glucose monitoring was performed at baseline and during the trial. The primary endpoint was the change in haemoglobin A1c from baseline to week 24. Additional endpoints include changes in weight, fasting glucose, glycaemic variability, treatment satisfaction, insulin dose, hypoglycaemias, blood pressure and blood lipid levels.
  
  
  RESULTS
  Recruitment occurred between February 2013 and February 2014. A total of 124 patients were randomised. Study completion is anticipated in August 2014.
  
  
  CONCLUSIONS
  It is expected that the results of this study will establish whether adding liraglutide to patients with type 2 diabetes treated with MDI will improve glycaemic control, lower body weight, and influence glycaemic variability.
authors.affiliation: Department of Molecular and Clinical Medicine, University of Gothenburg, Gothenburg, Sweden; Department of Medicine, NU-Hospital Organization, Uddevalla, Sweden. Electronic address: lind.marcus@telia.com.
authors.forename: Marcus
authors.initials: M
authors.lastname: Lind
authors.affiliation: University of Washington, Seattle, WA, USA.
authors.forename: Irl B
authors.initials: IB
authors.lastname: Hirsch
authors.affiliation: Centre for Vascular Prevention, Danube-University Krems, Krems, Austria; Diabetes Prevention Unit, National Institute for Health and Welfare, Helsinki, Finland; Diabetes Research Group, King Abdulaziz University, Jeddah, Saudi Arabia.
authors.forename: Jaakko
authors.initials: J
authors.lastname: Tuomilehto
authors.affiliation: Department of Medicine, NU-Hospital Organization, Uddevalla, Sweden.
authors.forename: Sofia
authors.initials: S
authors.lastname: Dahlqvist
authors.affiliation: Lund University, Lund, Sweden.
authors.forename: Ole
authors.initials: O
authors.lastname: Torffvit
authors.affiliation: Statistiska Konsultgruppen, Gothenburg, Sweden.
authors.forename: Nils-Gunnar
authors.initials: NG
authors.lastname: Pehrsson
mesh_terms: D015415:Biomarkers / Q000097:blood; D001786:Blood Glucose / Q000187:drug effects / Q000378:metabolism; D002985:Clinical Protocols; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D052216:Glucagon-Like Peptide 1 / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D006442:Glycated Hemoglobin / Q000378:metabolism*; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D054795:Incretins / Q000008:administration & dosage* / Q000009:adverse effects; D007267:Injections; D007328:Insulin / Q000008:administration & dosage* / Q000009:adverse effects; D000069450:Liraglutide; D018579:Patient Selection; D012107:Research Design; D018401:Sample Size; D013548:Sweden; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D015415:Biomarkers; D001786:Blood Glucose; D052216:Glucagon-Like Peptide 1; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D054795:Incretins; D007328:Insulin; D000069450:Liraglutide; C517652:hemoglobin A1c protein, human
keywords: Diabetes type 2; GLP-1; Insulin injections; Liraglutide; Overweight