title: Efficacy and safety of the glucagon-like peptide-1 receptor agonist liraglutide added to insulin therapy in poorly regulated patients with type 1 diabetes--a protocol for a randomised, double-blind, placebo-controlled study: the Lira-1 study.
abstract: BACKGROUND
  Intensive insulin therapy is recommended for the treatment of type 1 diabetes (T1D). Hypoglycaemia and weight gain are the common side effects of insulin treatment and may reduce compliance. In patients with insulin-treated type 2 diabetes, the addition of glucagon-like peptide-1 receptor agonist (GLP-1RA) therapy has proven effective in reducing weight gain and insulin dose. The present publication describes a protocol for a study evaluating the efficacy and safety of adding a GLP-1RA to insulin treatment in overweight patients with T1D in a randomised, double-blinded, controlled design.
  
  
  METHODS
  In total, 100 patients with type 1 diabetes, poor glycaemic control (glycated haemoglobin (HbA1c) >8%) and overweight (body mass index >25 kg/m(2)) will be randomised to either liraglutide 1.8 mg once daily or placebo as an add-on to intensive insulin therapy in this investigator initiated, double-blinded, placebo-controlled parallel study. The primary end point is glycaemic control as measured by changes in HbA1c. Secondary end points include changes in the insulin dose, hypoglyacemic events, body weight, lean body mass, fat mass, food preferences and adverse events. Glycaemic excursions, postprandial glucagon levels and gastric emptying rate during a standardised liquid meal test will also be studied.
  
  
  BACKGROUND
  The study is approved by the Danish Medicines Authority, the Regional Scientific-Ethical Committee of the Capital Region of Denmark and the Data Protection Agency. The study will be carried out under the surveillance and guidance of the good clinical practice (GCP) unit at Copenhagen University Hospital Bispebjerg in accordance with the ICH-GCP guidelines and the Helsinki Declaration.
  
  
  BACKGROUND
  NCT01612468.
authors.affiliation: Steno Diabetes Center, Gentofte, Denmark Department of Endocrinology, Hvidovre Hospital, University of Copenhagen, Hvidovre, Denmark.
authors.forename: Thomas Fremming
authors.initials: TF
authors.lastname: Dejgaard
authors.affiliation: Center for Diabetes Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark Faculty of Health and Medical Sciences, Department of Biomedical Sciences, The NNF Center for Basic Metabolic Research, University of Copenhagen, Copenhagen, Denmark.
authors.forename: Filip Krag
authors.initials: FK
authors.lastname: Knop
authors.affiliation: Nordsjællands Hospital, University of Copenhagen, Hillerød, Denmark.
authors.forename: Lise
authors.initials: L
authors.lastname: Tarnow
authors.affiliation: Department of Endocrinology, Hvidovre Hospital, University of Copenhagen, Hvidovre, Denmark.
authors.forename: Christian Seerup
authors.initials: CS
authors.lastname: Frandsen
authors.affiliation: Steno Diabetes Center, Gentofte, Denmark.
authors.forename: Tanja Stenbæk
authors.initials: TS
authors.lastname: Hansen
authors.affiliation: Center for Diabetes Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.
authors.forename: Thomas
authors.initials: T
authors.lastname: Almdal
authors.affiliation: Faculty of Health and Medical Sciences, Department of Biomedical Sciences, The NNF Center for Basic Metabolic Research, University of Copenhagen, Copenhagen, Denmark.
authors.forename: Jens Juul
authors.initials: JJ
authors.lastname: Holst
authors.affiliation: Department of Endocrinology, Hvidovre Hospital, University of Copenhagen, Hvidovre, Denmark.
authors.forename: Sten
authors.initials: S
authors.lastname: Madsbad
authors.affiliation: Steno Diabetes Center, Gentofte, Denmark.
authors.forename: Henrik Ullits
authors.initials: HU
authors.lastname: Andersen
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002985:Clinical Protocols; D003922:Diabetes Mellitus, Type 1 / Q000150:complications / Q000188:drug therapy*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D007328:Insulin / Q000627:therapeutic use*; D000069450:Liraglutide / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D050177:Overweight / Q000150:complications; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D007004:Hypoglycemic Agents; D007328:Insulin; D000069450:Liraglutide
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