title: Comparison of efficacy and safety of once- versus twice-daily insulin detemir added on to oral antidiabetics in insulin-naive type 2 diabetes patients: 24-week, crossover, treat to target trial in a single center.
abstract: OBJECTIVE
  To compare once- versus twice-daily insulin detemir added on OADS therapy in insulin-naive type 2 diabetes patients in terms of efficacy and safety.
  
  
  METHODS
  An open-label study performed at a single center, comprised a randomized, crossover 24 week with insulin-naive type 2 diabetes patients. Insulin detemir was initiated with mean 0.12 U/kg in all patients (Group I once-daily, Group II twice-daily) and titrated for 24 week.
  
  
  RESULTS
  A total of 50 patients completed the study (Group I n:25, Group II n:25). With use of once- and twice-daily insulin, HbA1c values were decreased by 1.8% (±2.0) and 1.5% (±1.4) within the first 12 weeks (p<0.01), whereas increased by 0.21% (±0.7) and 0.14% (±0.8) in the second 12 weeks (p>0.05). The increases in the insulin doses were found as 0.22 U/kg and 0.35 U/kg with once- and twice-daily insulin use, respectively (p:0.04). Although minor hypoglycemic events were similar in both groups in the first 12 weeks, 2-fold increase was found in the patients shifting from once- to twice-daily dose. Within the first and second periods, the body weight of the patients was observed an increase of 0.4 and 1.6 kg with once-daily dose, whereas a decrease of 0.1 and 2.1 kg in the twice-daily dose, in the same period.
  
  
  CONCLUSIONS
  Once-daily use of insulin detemir up to 0.4 U/kg was found to have similar efficacy and safety as twice-daily use. Twice dose use of insulin did not provide a prominent glycemic control advantage on 1.5-fold higher use of insulin.
authors: Uludag University Medical School, Department of Endocrinology and Metabolism, Bursa, Turkey; Bursa Sevket Yilmaz Education and Research Hospital, Division of Endocrinology and Metabolism, Bursa, Turkey. Electronic address: drcander@gmail.com.
authors: Soner
authors: S
authors: Cander
authors: Uludag University Medical School, Department of Internal Medicine, Bursa, Turkey.
authors: Oguzhan Sitki
authors: OS
authors: Dizdar
authors: Uludag University Medical School, Department of Endocrinology and Metabolism, Bursa, Turkey; Bursa Sevket Yilmaz Education and Research Hospital, Division of Endocrinology and Metabolism, Bursa, Turkey.
authors: Ozen
authors: O
authors: Oz Gul
authors: Uludag University Medical School, Department of Endocrinology and Metabolism, Bursa, Turkey; Bursa Sevket Yilmaz Education and Research Hospital, Division of Endocrinology and Metabolism, Bursa, Turkey.
authors: Metin
authors: M
authors: Guclu
authors: Uludag University Medical School, Department of Endocrinology and Metabolism, Bursa, Turkey.
authors: Oguz Kaan
authors: OK
authors: Unal
authors: Uludag University Medical School, Department of Endocrinology and Metabolism, Bursa, Turkey.
authors: Ercan
authors: E
authors: Tuncel
authors: Uludag University Medical School, Department of Endocrinology and Metabolism, Bursa, Turkey.
authors: Erdinc
authors: E
authors: Erturk
authors: Uludag University Medical School, Department of Endocrinology and Metabolism, Bursa, Turkey.
authors: Sazi
authors: S
authors: Imamoglu
authors: Uludag University Medical School, Department of Endocrinology and Metabolism, Bursa, Turkey.
authors: Canan
authors: C
authors: Ersoy
mesh_terms: D000284:Administration, Oral; D015415:Biomarkers / Q000097:blood; D001786:Blood Glucose / Q000187:drug effects / Q000378:metabolism; D018592:Cross-Over Studies; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy*; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007003:Hypoglycemia / Q000139:chemically induced; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D007267:Injections; D000069057:Insulin Detemir; D049528:Insulin, Long-Acting / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D013997:Time Factors; D016896:Treatment Outcome; D014421:Turkey; D015430:Weight Gain / Q000187:drug effects
chemical_list: D015415:Biomarkers; D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D000069057:Insulin Detemir; D049528:Insulin, Long-Acting; C517652:hemoglobin A1c protein, human
keywords: Detemir; HbA1c; Hypoglycemia; Insulin dose; Once daily; Type 2 diabetes