Abstract | AIM: The Predictable Results and Experience in Diabetes through Intensification and Control to Target: An International Variability Evaluation (PREDICTIVE) Study is a large, multi-centre, observational study assessing the safety and efficacy of insulin detemir in everyday clinical practice. METHODS: RESULTS: Among all groups, 3 months after starting treatment with insulin detemir, total, daytime and nocturnal hypoglycaemic events/patient were reduced by 84, 80 and 90%, respectively, from baseline. No major hypoglycaemic events were reported during treatment with insulin detemir. HbAlc was significantly reduced from baseline in each of the subgroups (-1.29,-0.60 and-0.59% for patients previously taking OADs only, NPH insulin +/- OADs and insulin glargine +/- OADs respectively; p < 0.0001), as was fasting blood glucose (FBG) (-58.1,-29.1 and-24.6 mg/dl; p < 0.0001) and FBG variability-8.2 mg/dl,-5.7 mg/dl; p < 0.0001 and -5.1 mg/dl; p = 0.0008). All subgroups combined lost an average of 0.9 kg of body weight (p < 0.0001) during the study. Total daily basal insulin dose increased slightly from baseline for those patients on a prior insulin regimen, and in this study 79% of patients used insulin detemir once daily. CONCLUSIONS: These data confirm the short-term safety and efficacy of insulin detemir +/- OADs in a real-world scenario and support the findings of randomized controlled clinical trials with insulin detemir, including its limited effects on body weight.
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Authors | L F Meneghini, K H Rosenberg, C Koenen, M J Merilainen, H-J Lüddeke |
Journal | Diabetes, obesity & metabolism
(Diabetes Obes Metab)
Vol. 9
Issue 3
Pg. 418-27
(May 2007)
ISSN: 1462-8902 [Print] England |
PMID | 17391170
(Publication Type: Journal Article, Multicenter Study)
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Chemical References |
- Blood Glucose
- Glycated Hemoglobin A
- Hypoglycemic Agents
- Insulin
- Insulin, Long-Acting
- Insulin Glargine
- Insulin Detemir
- Insulin, Isophane
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Topics |
- Administration, Oral
- Blood Glucose
(drug effects)
- Cohort Studies
- Diabetes Mellitus, Type 2
(complications, drug therapy, physiopathology)
- Drug Administration Schedule
- Female
- Glycated Hemoglobin
(analysis)
- Humans
- Hypoglycemia
(complications, physiopathology)
- Hypoglycemic Agents
(administration & dosage, adverse effects, therapeutic use)
- Insulin
(administration & dosage, adverse effects, agonists, analogs & derivatives, therapeutic use)
- Insulin Detemir
- Insulin Glargine
- Insulin, Isophane
(therapeutic use)
- Insulin, Long-Acting
- Male
- Middle Aged
- Treatment Outcome
- Weight Loss
(drug effects)
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