title: Efficacy and Safety of Metreleptin Therapy in Patients With Type 1 Diabetes: A Pilot Study.
abstract: To study the efficacy and safety of metreleptin therapy in patients with suboptimally controlled type 1 diabetes mellitus (T1DM).
  
  
  
  After a baseline period of 4 weeks, five female and three male patients with T1DM (mean age 33 years, BMI 23.8 kg/m2) received metreleptin (0.08 mg/kg/day in females and 0.04 mg/kg/day in males) subcutaneously twice daily for 20 weeks followed by an off-therapy period of 4 weeks.
  
  
  
  Metreleptin therapy did not lower HbA1csignificantly compared with the baseline value (mean difference -0.19% [-2.0 mmol/mol] and -0.04% [-0.5 mmol/mol] at 12 and 20 weeks, respectively). Mean body weight reduced significantly by 2.6 and 4.7 kg (P= 0.003) and daily insulin dose by 12.6% and 15.0% at week 12 and 20 (P= 0.006), respectively.
  
  
  
  Metreleptin is safe but may not be efficacious in improving glycemic control in patients with T1DM, although it reduces body weight and daily insulin dose modestly.
authors.affiliation: Division of Nutrition and Metabolic Diseases and the Center for Human Nutrition, The University of Texas Southwestern Medical Center, Dallas, TX.
authors.forename: Chandna
authors.initials: C
authors.lastname: Vasandani
authors.affiliation: Division of Endocrinology and Metabolism, The University of Texas Southwestern Medical Center, Dallas, TX.
authors.forename: Gregory O
authors.initials: GO
authors.lastname: Clark
authors.affiliation: Department of Internal Medicine and Department of Clinical Sciences, The University of Texas Southwestern Medical Center, Dallas, TX.
authors.forename: Beverley
authors.initials: B
authors.lastname: Adams-Huet
authors.affiliation: Division of Nutrition and Metabolic Diseases and the Center for Human Nutrition, The University of Texas Southwestern Medical Center, Dallas, TX.
authors.forename: Claudia
authors.initials: C
authors.lastname: Quittner
authors.affiliation: Division of Nutrition and Metabolic Diseases and the Center for Human Nutrition, The University of Texas Southwestern Medical Center, Dallas, TX abhimanyu.garg@utsouthwestern.edu.
authors.forename: Abhimanyu
authors.identifier: 0000-0001-7209-6986
authors.initials: A
authors.lastname: Garg
mesh_terms: D000328:Adult; D001786:Blood Glucose / Q000378:metabolism; D001835:Body Weight / Q000187:drug effects; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000188:drug therapy*; D005260:Female; D006442:Glycated Hemoglobin / Q000187:drug effects / Q000378:metabolism; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D007328:Insulin / Q000008:administration & dosage / Q000627:therapeutic use; D020738:Leptin / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D008297:Male; D010865:Pilot Projects; D016896:Treatment Outcome
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin; D020738:Leptin; C415771:metreleptin