title: Addition of Liraglutide to Insulin in Patients With Type 1 Diabetes: A Randomized Placebo-Controlled Clinical Trial of 12 Weeks.
abstract: To investigate whether addition of three different doses of liraglutide to insulin in patients with type 1 diabetes (T1D) results in significant reduction in glycemia, body weight, and insulin dose.
  
  
  
  We randomized 72 patients (placebo = 18, liraglutide = 54) with T1D to receive placebo and 0.6, 1.2, and 1.8 mg liraglutide daily for 12 weeks.
  
  
  
  In the 1.2-mg and 1.8-mg groups, the mean weekly reduction in average blood glucose was -0.55 ± 0.11 mmol/L (10 ± 2 mg/dL) and -0.55 ± 0.05 mmol/L (10 ± 1 mg/dL), respectively (P < 0.0001), while it remained unchanged in the 0.6-mg and placebo groups. In the 1.2-mg group, HbA1c fell significantly (-0.78 ± 15%, -8.5 ± 1.6 mmol/mol, P < 0.01), while it did not in the 1.8-mg group (-0.42 ± 0.15%, -4.6 ± 1.6 mmol/mol, P = 0.39) and 0.6-mg group (-0.26 ± 0.17%, -2.8 ± 1.9 mmol/mol, P = 0.81) vs. the placebo group (-0.3 ± 0.15%, -3.3 ± 1.6 mmol/mol). Glycemic variability was reduced by 5 ± 1% (P < 0.01) in the 1.2-mg group only. Total daily insulin dose fell significantly only in the 1.2-mg and 1.8-mg groups (P < 0.05). There was a 5 ± 1 kg weight loss in the two higher-dose groups (P < 0.05) and by 2.7 ± 0.6 kg (P < 0.01) in the 0.6-mg group vs. none in the placebo group. In the 1.2- and 1.8-mg groups, postprandial plasma glucagon concentration fell by 72 ± 12% and 47 ± 12%, respectively (P < 0.05). Liraglutide led to higher gastrointestinal adverse events (P < 0.05) and ≤1% increases (not significant) in percent time spent in hypoglycemia (<55 mg/dL, 3.05 mmol/L).
  
  
  
  Addition of 1.2 mg and 1.8 mg liraglutide to insulin over a 12-week period in overweight and obese patients with T1D results in modest reductions of weekly mean glucose levels with significant weight loss, small insulin dose reductions, and frequent gastrointestinal side effects. These findings do not justify the use of liraglutide in all patients with T1D.
authors.affiliation: Division of Endocrinology, Diabetes and Metabolism, State University of New York at Buffalo, Buffalo, NY.
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, NY Division of Endocrinology, Diabetes and Metabolism, Texas Tech University Health Sciences Center, Odessa, TX.
authors.forename: Sandeep
authors.initials: S
authors.lastname: Dhindsa
authors.affiliation: Division of Endocrinology, Diabetes and Metabolism, State University of New York at Buffalo, Buffalo, NY.
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, NY.
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, NY.
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, NY.
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, NY.
authors.forename: Sartaj
authors.initials: S
authors.lastname: Sandhu
authors.affiliation: Division of Endocrinology, Diabetes and Metabolism, State University of New York at Buffalo, Buffalo, NY.
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, NY.
authors.forename: Kelly
authors.initials: K
authors.lastname: Green
authors.affiliation: Division of Endocrinology, Diabetes and Metabolism, State University of New York at Buffalo, Buffalo, NY.
authors.forename: Natalie
authors.initials: N
authors.lastname: Bellini
authors.affiliation: Department of Family Medicine, State University of New York at Buffalo, Buffalo, NY.
authors.forename: Min
authors.initials: M
authors.lastname: Yang
authors.affiliation: Division of Endocrinology, Diabetes and Metabolism, State University of New York at Buffalo, Buffalo, NY.
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, NY pdandona@kaleidahealth.org.
authors.forename: Paresh
authors.initials: P
authors.lastname: Dandona
mesh_terms: D000328:Adult; D001786:Blood Glucose / Q000378:metabolism; D001835:Body Weight; D003922:Diabetes Mellitus, Type 1 / Q000150:complications / Q000188:drug therapy* / Q000378:metabolism; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005934:Glucagon / Q000378:metabolism; D006801:Humans; D007003:Hypoglycemia / Q000139:chemically induced; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D007328:Insulin / Q000627:therapeutic use*; D000069450:Liraglutide / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000150:complications; D050177:Overweight / Q000150:complications; D019518:Postprandial Period; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D001786:Blood Glucose; D007004:Hypoglycemic Agents; D007328:Insulin; D000069450:Liraglutide; D005934:Glucagon