title: Dapagliflozin as Additional Treatment to Liraglutide and Insulin in Patients With Type 1 Diabetes.
abstract: It is imperative that novel approaches to treatment of type 1 diabetes (T1D) are devised.
  
  
  
  The objective of the study was to investigate whether addition of dapagliflozin to insulin and liraglutide results in a significant reduction in glycemia and body weight.
  
  
  
  This was a randomized clinical trial.
  
  
  
  The study was conducted at a single academic medical center.
  
  
  
  Participants included T1D patients on liraglutide therapy for at least last 6 months.
  
  
  
  Thirty T1D patients were randomized (in 2:1 ratio) to receive either dapagliflozin 10 mg or placebo daily for 12 weeks.
  
  
  
  Change in mean glycated hemoglobin after 12 weeks of dapagliflozin when compared with placebo was measured.
  
  
  
  In the dapagliflozin group, glycated hemoglobin fell by 0.66% ± 0.08% from 7.8% ± 0.21% (P < .01 vs placebo), whereas it did not change significantly in the placebo group from 7.40% ± 0.20% to 7.30% ± 0.20%. The body weight fell by1.9 ± 0.54kg (P < .05 vs placebo). There was no additional hypoglycemia (blood glucose < 3.88 mmol/L; P = .52 vs placebo). In the dapagliflozin group, there were significant increases in the plasma concentrations of glucagon by 35% ± 13% (P < .05), hormone-sensitive lipase by 29% ± 11% (P < .05), free fatty acids by 74% ± 32% (P < .05), acetoacetate by 67% ± 34% (P < .05), and β-hydroxybutyrate by 254% ± 81% (P < .05). Urinary ketone levels also increased significantly (P < .05). None of these changes was observed in the placebo group. Two patients in the dapagliflozin group developed diabetic ketoacidosis.
  
  
  
  Addition of dapagliflozin to insulin and liraglutide in patients with T1D results in a significant improvement in glycemia and weight loss while increasing ketosis. If it is decided to use this approach, then it must be used only by a knowledgeable patient along with an endocrinologist who is well versed with it.
authors.affiliation: Division of Endocrinology, Diabetes, and Metabolism, State University of New York at Buffalo, Buffalo, New York 14215.
authors.forename: Nitesh D
authors.initials: ND
authors.lastname: Kuhadiya
authors.affiliation: Division of Endocrinology, Diabetes, and Metabolism, State University of New York at Buffalo, Buffalo, New York 14215.
authors.forename: Husam
authors.initials: H
authors.lastname: Ghanim
authors.affiliation: Division of Endocrinology, Diabetes, and Metabolism, State University of New York at Buffalo, Buffalo, New York 14215.
authors.forename: Aditya
authors.initials: A
authors.lastname: Mehta
authors.affiliation: Division of Endocrinology, Diabetes, and Metabolism, State University of New York at Buffalo, Buffalo, New York 14215.
authors.forename: Manisha
authors.initials: M
authors.lastname: Garg
authors.affiliation: Division of Endocrinology, Diabetes, and Metabolism, State University of New York at Buffalo, Buffalo, New York 14215.
authors.forename: Salman
authors.initials: S
authors.lastname: Khan
authors.affiliation: Division of Endocrinology, Diabetes, and Metabolism, State University of New York at Buffalo, Buffalo, New York 14215.
authors.forename: Jeanne
authors.initials: J
authors.lastname: Hejna
authors.affiliation: Division of Endocrinology, Diabetes, and Metabolism, State University of New York at Buffalo, Buffalo, New York 14215.
authors.forename: Barrett
authors.initials: B
authors.lastname: Torre
authors.affiliation: Division of Endocrinology, Diabetes, and Metabolism, State University of New York at Buffalo, Buffalo, New York 14215.
authors.forename: Antoine
authors.initials: A
authors.lastname: Makdissi
authors.affiliation: Division of Endocrinology, Diabetes, and Metabolism, State University of New York at Buffalo, Buffalo, New York 14215.
authors.forename: Ajay
authors.initials: A
authors.lastname: Chaudhuri
authors.affiliation: Division of Endocrinology, Diabetes, and Metabolism, State University of New York at Buffalo, Buffalo, New York 14215.
authors.forename: Manav
authors.initials: M
authors.lastname: Batra
authors.affiliation: Division of Endocrinology, Diabetes, and Metabolism, State University of New York at Buffalo, Buffalo, New York 14215.
authors.forename: Paresh
authors.initials: P
authors.lastname: Dandona
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001559:Benzhydryl Compounds / Q000627:therapeutic use*; D015415:Biomarkers / Q000032:analysis*; D001786:Blood Glucose / Q000032:analysis; D003922:Diabetes Mellitus, Type 1 / Q000188:drug therapy* / Q000378:metabolism; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D005960:Glucosides / Q000627:therapeutic use*; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D007328:Insulin / Q000627:therapeutic use*; D000069450:Liraglutide / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D055815:Young Adult
chemical_list: D001559:Benzhydryl Compounds; D015415:Biomarkers; D001786:Blood Glucose; D005960:Glucosides; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin; D000069450:Liraglutide; C517652:hemoglobin A1c protein, human; C529054:dapagliflozin