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. 2007 Summer;4(2):89-97.
doi: 10.1900/RDS.2007.4.89. Epub 2007 Aug 10.

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  1 , Per Lund, Kurt Clemmensen, Leif Breum, Marianne Kleis Moller, Anne Mette Rosenfalck, Erik Christiansen; Danish PREDICTIVE study group
Affiliations

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 et al. Rev Diabet Stud. 2007 Summer.

Abstract

PREDICTIVEtrade mark 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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Figures

Figure 1
Figure 1
Mean body weight after 17 weeks insulin detemir therapy. Dark-gray: baseline. Light-gray: follow-up. * p = 0.025, ** p = 0.036.
Figure 2
Figure 2. Total hypoglycemia
Hypoglycemic episodes are defined as symptomatic or asymptomatic blood glucose < 2.8 mmol/l (50 mg/dl). Dark-gray: baseline (4 weeks prior to study start). Light-gray: follow up (4 weeks prior to follow-up). * p < 0.0001. ** p < 0.0012.
Figure 3
Figure 3. Nocturnal hypoglycemia
Dark-gray: baseline (4 weeks prior to study start). Light-gray: follow-up (4 weeks prior to follow-up). * p < 0.0001, † p < 0.002.
Figure 4
Figure 4. Major hypoglycemia
Dark-gray: baseline (4 weeks prior to study start). Light-gray: follow-up (4 weeks prior to follow-up). * p < 0.0001. ‡ p < 0.125.
See this image and copyright information in PMC

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