The Review of Diabetic Studies

3-Month Results from Denmark within the Globally Prospective and Observational Study to Evaluate Insulin Detemir Treatment in Type 1 and Type 2 Diabetes: The PREDICTIVE Study

Kjeld Hermansen
Department of Endocrinology and Metabolism, Aarhus Sygehus THG, Aarhus University Hospital, Tage-Hansens Gade 2, 8000 Aarhus C, Denmark
Per Lund
Nordsjællands Hospital, Helsingør, Esrumvej 145, 3000 Helsingør, Denmark
Kurt Clemmensen
Frederikshavn Hospital, Barfredsvej 83, 9900 Frederikshavn, Denmark.
Leif Breum
Koge Hospital, Lykkebækvej 1, 4600 Koge, Denmark.
Marianne Kleis Moller
Regionshospitalet Horsens, Sundvej 30, 8700 Horsens, Denmark.
Anne Mette Rosenfalck
Novo Nordisk Scandinavia AB, Region Danmark, Arne Jacobsens Allé 15, 2300 Copenhagen S, Denmark
Erik Christiansen
Roskilde Hospital, Kogevej 7-13, 4000 Roskilde, Denmark


PREDICTIVE is a large, multi-national, open-label, prospective, observational study to assess the efficacy and safety of insulin detemir in clinical practice. We report 3-month follow-up data from 389 patients with type 1 (n = 312) and type 2 (n = 77) diabetes from Denmark. Insulin detemir improved glycemic control in type 1 patients, with decreases in mean HbA1c (-0.2%, p = 0.0026), fasting glucose (-1.7 mmol/l, p = 0.0033) and within-patient fasting glucose variability (-0.6 mmol/l, p = 0.0472). Non-significant reductions in glycemic parameters were observed in type 2 patients (-0.3% for HbA1c and -2.7 mmol/l for fasting glucose). There was a decrease in mean body weight in both type 1 and type 2 patients (-0.6 kg, p = 0.025 and -1.0 kg, p = 0.0361, respectively). Three patients (0.8%) reported 4 serious adverse drug reactions, including major hypoglycemia. The incidence of major hypoglycemic episodes was reduced from 3.9/patient-years at baseline to 0.4/patient-years at follow-up in type 1 patients (p < 0.0001), and from 1.0 to 0.0/patient-years in type 2 patients (p = 0.1250). In addition, the mean incidence of total and nocturnal hypoglycemic episodes was reduced in both type 1 (-37.4 and -17.7/patientyears, p < 0.0001 for both) and type 2 patients (-17.7 and -7.8/patient-years, p = 0.0012 and p = 0.0020, respectively). The observations from the Danish cohort of the PREDICTIVE study support the overall findings of PREDICTIVE, i.e. insulin detemir improves glycemic control, with a reduced risk of hypoglycemia and no weight gain.

diabetes · insulin analogues · glycemic control · hypoglycemia · diabetes treatment · observational study,.



Demosthenes Panagiotakos

Abbreviation Title

Rev Diabet Stud