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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