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

Original Data

Rev Diabet Stud, 2007, 4(2):89-97

DOI 10.1900/RDS.2007.4.89

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 Hermansen¹, Per Lund², Kurt Clemmensen³, Leif Breum⁴, Marianne Kleis Moller⁵, Anne Mette Rosenfalck⁶, Erik Christiansen⁷, on behalf of the Danish PREDICTIVE study group

¹Department of Endocrinology and Metabolism, Aarhus Sygehus THG, Aarhus University Hospital, Tage-Hansens Gade 2, 8000 Aarhus C, Denmark.
²Nordsjaellands Hospital, Helsingor, Esrumvej 145, 3000 Helsingor, Denmark.
³Frederikshavn Hospital, Barfredsvej 83, 9900 Frederikshavn, Denmark.
⁴Koge Hospital, Lykkebaekvej 1, 4600 Koge, Denmark.
⁵Regionshospitalet Horsens, Sundvej 30, 8700 Horsens, Denmark.
⁶Novo Nordisk Scandinavia AB, Region Danmark, Arne Jacobsens Alle 15, 2300 Copenhagen S, Denmark.
⁷Roskilde Hospital, Kogevej 7-13, 4000 Roskilde, Denmark.
Address correspondence to: Kjeld Hermansen, e-mail: kjeld.hermansen@as.aaa.dk

Keywords: diabetes, insulin analogues, glycemic control, hypoglycemia, diabetes treatment, observational study

Abstract

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/patient-years, 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.

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