Appropriate Insulin Regimes for Type 2 Diabete
Objective: To directly compare the rate of hypoglycemia and metabolic control achieved on once-daily ultralente insulin administration with twice-daily NPH insulin administration in patients with type 2 diabetes. Patient treatment satisfaction and quality of life were also examined before and during each treatment.
Research Design and Methods: A crossover study was performed involving five centers and 79 patients with type 2 diabetes (fasting blood glucose >8 mmol/l) with a 2-month run-in followed by two 6-month periods of either NPH or ultralente insulin administration. Patients were managed by a specialist nurse using a dosage adjustment protocol.
Results: HbA1c was lower with NPH insulin therapy during each of the 6-month periods (9.7 ± 0.2 vs. 9.1 ± 0.3 and 9.8 ± 0.2 vs. 9.0 ± 0.3 mmol/l; both P < 0.01). The difference was accounted for by higher evening glucose levels with ultralente insulin (fasting 8.2 ± 0.3 vs. 8.2 ± 0.3 mmol/l, 6:00 p.m. 11.5 ± 0.4 vs. 10.6 ± 0.4 mmol/l). Despite worse control, the total number of hypoglycemic episodes was greater with ultralente insulin (220 vs. 171), and hypoglycemic episodes requiring third-party assistance occurred almost entirely with ultralente (14 vs. 1). Treatment satisfaction scores increased more with NPH insulin compared with ultralente and rose further upon changing to NPH insulin, but fell upon changing to ultralente insulin. These changes were highly significant (P < 0.001). Diabetes quality of life improved on both regimens.
Conclusions: These data clearly demonstrate the lower hypoglycemia rate, better glucose control, and greater treatment satisfaction accompanying therapy for type 2 diabetes with twice daily NPH compared with once daily ultralente insulin.
The dramatic impact of the U.K. Prospective Diabetes Study (UKPDS) data has drawn attention to the use of insulin in type 2 diabetes . Current interest in achieving good blood glucose control has led to the compilation of guidelines on optimal management of the condition . However, practical information on the impact of any one insulin regimen on patients is scarce. Both patients and doctors are concerned about the risk of hypoglycemia , but few studies have defined the frequency of hypoglycemia under routine clinical conditions . The anecdotal increase in well-being and treatment satisfaction after commencement of insulin therapy has previously been quantified , but there is little evidence concerning the comparative extent of such effects as they relate to different insulin regimens. Similarly, the diurnal pattern of blood glucose control achieved during insulin therapy for type 2 diabetes requires description for the various insulin regimens. It is important to note that the applicability of regimens has rarely been tested outside of specialized centers.
The original UKPDS protocol described only the use of once-daily ultralente insulin administered before the evening meal . Published information suggested a relatively high rate of hypoglycemia on this regimen, with 5.6–12 hypoglycemic episodes per patient-year . In contrast, use of twice-daily intermediate-acting (NPH) insulin under usual clinical conditions has been reported to be associated with only three episodes per patient-year . It is commonly assumed by doctors and nurses that once-daily insulin will be better accepted by patients than twice-daily insulin, but no reliable information exists to test this premise.
The Appropriate Insulin Regime Study, a randomized crossover study, was therefore designed to compare twice-daily NPH insulin with once-daily ultralente insulin under conditions of routine clinical care. To ensure general applicability of the findings and to avoid bias introduced as a consequence of the enthusiasm of any one investigator for a particular regimen, it was designed as a multicenter study. The specific objectives were to compare between each regimen rates of hypoglycemia, efficacy in achieving diurnal blood glucose control, and degrees of well-being and treatment satisfaction.
Objective: To directly compare the rate of hypoglycemia and metabolic control achieved on once-daily ultralente insulin administration with twice-daily NPH insulin administration in patients with type 2 diabetes. Patient treatment satisfaction and quality of life were also examined before and during each treatment.
Research Design and Methods: A crossover study was performed involving five centers and 79 patients with type 2 diabetes (fasting blood glucose >8 mmol/l) with a 2-month run-in followed by two 6-month periods of either NPH or ultralente insulin administration. Patients were managed by a specialist nurse using a dosage adjustment protocol.
Results: HbA1c was lower with NPH insulin therapy during each of the 6-month periods (9.7 ± 0.2 vs. 9.1 ± 0.3 and 9.8 ± 0.2 vs. 9.0 ± 0.3 mmol/l; both P < 0.01). The difference was accounted for by higher evening glucose levels with ultralente insulin (fasting 8.2 ± 0.3 vs. 8.2 ± 0.3 mmol/l, 6:00 p.m. 11.5 ± 0.4 vs. 10.6 ± 0.4 mmol/l). Despite worse control, the total number of hypoglycemic episodes was greater with ultralente insulin (220 vs. 171), and hypoglycemic episodes requiring third-party assistance occurred almost entirely with ultralente (14 vs. 1). Treatment satisfaction scores increased more with NPH insulin compared with ultralente and rose further upon changing to NPH insulin, but fell upon changing to ultralente insulin. These changes were highly significant (P < 0.001). Diabetes quality of life improved on both regimens.
Conclusions: These data clearly demonstrate the lower hypoglycemia rate, better glucose control, and greater treatment satisfaction accompanying therapy for type 2 diabetes with twice daily NPH compared with once daily ultralente insulin.
The dramatic impact of the U.K. Prospective Diabetes Study (UKPDS) data has drawn attention to the use of insulin in type 2 diabetes . Current interest in achieving good blood glucose control has led to the compilation of guidelines on optimal management of the condition . However, practical information on the impact of any one insulin regimen on patients is scarce. Both patients and doctors are concerned about the risk of hypoglycemia , but few studies have defined the frequency of hypoglycemia under routine clinical conditions . The anecdotal increase in well-being and treatment satisfaction after commencement of insulin therapy has previously been quantified , but there is little evidence concerning the comparative extent of such effects as they relate to different insulin regimens. Similarly, the diurnal pattern of blood glucose control achieved during insulin therapy for type 2 diabetes requires description for the various insulin regimens. It is important to note that the applicability of regimens has rarely been tested outside of specialized centers.
The original UKPDS protocol described only the use of once-daily ultralente insulin administered before the evening meal . Published information suggested a relatively high rate of hypoglycemia on this regimen, with 5.6–12 hypoglycemic episodes per patient-year . In contrast, use of twice-daily intermediate-acting (NPH) insulin under usual clinical conditions has been reported to be associated with only three episodes per patient-year . It is commonly assumed by doctors and nurses that once-daily insulin will be better accepted by patients than twice-daily insulin, but no reliable information exists to test this premise.
The Appropriate Insulin Regime Study, a randomized crossover study, was therefore designed to compare twice-daily NPH insulin with once-daily ultralente insulin under conditions of routine clinical care. To ensure general applicability of the findings and to avoid bias introduced as a consequence of the enthusiasm of any one investigator for a particular regimen, it was designed as a multicenter study. The specific objectives were to compare between each regimen rates of hypoglycemia, efficacy in achieving diurnal blood glucose control, and degrees of well-being and treatment satisfaction.
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