title: Short-term therapy with combination dipeptidyl peptidase-4 inhibitor saxagliptin/metformin extended release (XR) is superior to saxagliptin or metformin XR monotherapy in prediabetic women with polycystic ovary syndrome: a single-blind, randomized, pilot study.
abstract: To evaluate efficacy with the dipeptidyl peptidase-4 inhibitor saxagliptin (SAXA), metformin extended release (MET), and combination (SAXA-MET) in patients with polycystic ovary syndrome (PCOS) and impaired glucose regulation.
  
  
  
  Prospective, randomized, single-blind drug study.
  
  
  
  Outpatient clinic.
  
  
  
  Patients (n = 38) with PCOS (aged 18-42 years) and prediabetic hyperglycemia determined by a 75-gram oral glucose tolerance test.
  
  
  
  Patients were randomized to SAXA-MET (5 mg/2,000 mg), SAXA (5 mg), or MET (2,000 mg) for 16 weeks.
  
  
  
  Fasting and mean blood glucose, insulin sensitivity, insulin secretion, and insulin secretion-sensitivity index (IS-SI) by oral glucose tolerance tests. Free androgen index and lipid levels, average menstrual interval, and anthropometric measurements (body mass index, waist circumference, and waist/height ratio).
  
  
  
  The study was completed by 34 patients. Nineteen patients had normal glucose tolerance: 3 of 12 (25%) on MET; 6 of 11 (55%) on SAXA; and 10 of 11 (91%) on SAXA-MET (SAXA-MET statistically superior to MET) at study completion. Body mass index, waist circumference, waist/height ratio, free androgen index, insulin sensitivity, IS-SI, and menses improved in all groups; however, IS-SI and menstrual regularity were significantly better with SAXA-MET vs. MET treatment. Triglyceride, triglyceride/high-density lipoprotein cholesterol ratio and mean blood glucose significantly declined in the SAXA-MET and SAXA groups only.
  
  
  
  This pilot work provides the first evidence regarding the effects of a dipeptidyl peptidase-4 inhibitor alone and in combination with MET in this patient population. Treatment with SAXA-MET was superior to either drug alone in terms of clinical and metabolic benefits in prediabetic patients with PCOS.
  
  
  
  NCT02022007.
authors.affiliation: Woman's Metabolic Health and Research Services, Woman's Hospital, Baton Rouge, Louisiana. Electronic address: karen.elkind-hirsch@womans.org.
authors.forename: Karen E
authors.initials: KE
authors.lastname: Elkind-Hirsch
authors.affiliation: Woman's Metabolic Health and Research Services, Woman's Hospital, Baton Rouge, Louisiana.
authors.forename: Martha S
authors.initials: MS
authors.lastname: Paterson
authors.affiliation: Woman's Metabolic Health and Research Services, Woman's Hospital, Baton Rouge, Louisiana.
authors.forename: Ericka L
authors.initials: EL
authors.lastname: Seidemann
authors.affiliation: Woman's Metabolic Health and Research Services, Woman's Hospital, Baton Rouge, Louisiana.
authors.forename: Hanh C
authors.initials: HC
authors.lastname: Gutowski
mesh_terms: D000218:Adamantane / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D050154:Adiposity / Q000187:drug effects; D000293:Adolescent; D000328:Adult; D000728:Androgens / Q000097:blood; D015415:Biomarkers / Q000097:blood; D001786:Blood Glucose / Q000187:drug effects / Q000378:metabolism; D003692:Delayed-Action Preparations; D004151:Dipeptides / Q000008:administration & dosage* / Q000009:adverse effects; D054873:Dipeptidyl-Peptidase IV Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005260:Female; D005951:Glucose Tolerance Test; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D007328:Insulin / Q000097:blood; D008597:Menstrual Cycle / Q000187:drug effects; D008687:Metformin / Q000008:administration & dosage* / Q000009:adverse effects; D010865:Pilot Projects; D011085:Polycystic Ovary Syndrome / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D011236:Prediabetic State / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D016037:Single-Blind Method; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000728:Androgens; D015415:Biomarkers; D001786:Blood Glucose; D003692:Delayed-Action Preparations; D004151:Dipeptides; D054873:Dipeptidyl-Peptidase IV Inhibitors; D004338:Drug Combinations; D007004:Hypoglycemic Agents; D007328:Insulin; D008687:Metformin; C502994:saxagliptin; D000218:Adamantane
keywords: Dipeptidyl peptidase-4 inhibitor; polycystic ovary syndrome; prediabetic hyperglycemia; saxagliptin