PREDICTIVE™– a global, prospective observational study to evaluate insulin detemir treatment in types 1 and 2 diabetes: baseline characteristics and predictors of hypoglycaemia from the European cohort
- 14 December 2006
- journal article
- Published by Wiley in Diabetes, Obesity and Metabolism
- Vol. 9 (3), 428-434
- https://doi.org/10.1111/j.1463-1326.2006.00677.x
Abstract
PREDICTIVEtrade mark (Predictable Results and Experience in Diabetes through Intensification and Control to Target: An International Variability Evaluation) is a large, multi-national, observational study assessing the safety and efficacy of insulin detemir. We report the study design, population characteristics and baseline observations, including cross-sectional analysis, from 19 911 patients with type 1 or 2 diabetes. Patients with type 1 or 2 diabetes requiring basal insulin are prescribed insulin detemir and followed up for 12-52 weeks. Data on demographics, haemoglobin A(1c) (HbA(1c)), fasting glucose, within-subject fasting glucose variability and weight are collected from patient records (and/or recall for hypoglycaemia). A negative binomial distribution model is used to assess the influence of predictive/confounding variables on hypoglycaemic episodes in insulin-treated patients at baseline. Multi-factorial analysis of covariance is used to evaluate the association of the variables with current body weight and within-subject fasting glucose variability. Total hypoglycaemic episodes in the 4 weeks prior to study start were 47.5 per patient-year in patients with type 1 and 9.2 per patient-year in patients with type 2 diabetes. The frequency of hypoglycaemia in insulin-treated patients showed a significant, positive association with duration of diabetes, number of insulin injections and fasting glucose variability but was inversely related to HbA(1c), fasting glucose and body mass index. Weight showed a significant positive association with gender (male > female) and insulin dosage. Weight was also positively associated with fasting glucose variability in patients with type 1 diabetes, and age and number of injections in patients with type 2 diabetes. These baseline data showed that, in addition to the established relationship with intensive treatment and HbA(1c), frequency of hypoglycaemia was positively associated with fasting glucose variability. Follow-up data from PREDICTIVE will provide insights on insulin detemir in diabetes management.Keywords
This publication has 18 references indexed in Scilit:
- Measuring beliefs about taking hypoglycaemic medication among people with Type 2 diabetesDiabetic Medicine, 2006
- Obesity and cardiovascular risk factors in type 2 diabetes: results from the Swedish National Diabetes RegisterJournal of Internal Medicine, 2006
- Insulin detemir: from concept to clinical experienceExpert Opinion on Pharmacotherapy, 2006
- Insulin detemir and insulin aspart: a promising basal-bolus regimen for type 2 diabetesDiabetes Research and Clinical Practice, 2004
- Sources of glucose variability in insulin‐treated type 2 diabetes: the Diabetes Outcomes in Veterans Study (DOVES)Clinical Endocrinology, 2004
- Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33)The Lancet, 1998
- Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34)The Lancet, 1998
- Hypoglycemia in the Diabetes Control and Complications Trial. The Diabetes Control and Complications Trial Research GroupDiabetes, 1997
- The Effect of Intensive Treatment of Diabetes on the Development and Progression of Long-Term Complications in Insulin-Dependent Diabetes MellitusNew England Journal of Medicine, 1993
- Relationship between lactate dehydrogenase and myeloperoxidase levels in human gingival crevicular fluid and clinical and microbial measurementsJournal of Clinical Periodontology, 1988