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Comparison of thrice-daily lispro 50/50 vs thrice-daily lispro in combination with sulfonylurea as initial insulin therapy for type 2 diabetes.

Yamashiro K, Ikeda F, Fujitani Y, Watada H, Kawamori R, Hirose T - J Diabetes Investig (2010)

Bottom Line: Aims/Introduction:  Basal-bolus intensive insulin therapy has been believed to achieve best the glycemic control, but is also complicated as a result of the number of injections required and the type of insulin.The daily doses of PPT were more than those of PBTS, albeit the difference was statistically insignificant (P = 0.051).There were significantly fewer hypoglycemic episodes encountered with PPT than with PBTS.   Thrice-daily injections of lispro 50/50 provide an effective and safe regimen as initial insulin therapy for type 2 diabetes. (J Diabetes Invest, doi: 10.1111/j.2040-1124.2010.00025.x, 2010).

View Article: PubMed Central - PubMed

Affiliation: Department of Medicine, Metabolism and Endocrinology, Juntendo University Graduate School of Medicine.

ABSTRACT

Unlabelled: Aims/Introduction:  Basal-bolus intensive insulin therapy has been believed to achieve best the glycemic control, but is also complicated as a result of the number of injections required and the type of insulin. This study compared the effect of thrice-daily lispro 50/50 (prandial premixed therapy [PPT]) with thrice daily lispro given in combination with sulfonylureas (prandial bolus therapy with sulfonylurea [PBTS]) as initial insulin therapy for type 2 diabetes.

Materials and methods:   This 24-week, observational, parallel trial comprised a 12-week screening period and a 24-week intervention period for 31 diabetes patients who were poorly controlled with submaximal sulfonylurea. At the start of the intervention period, we commenced thrice-daily insulin injections and divided the 31 patients into either lispro 50/50 with discontinuation of sulfonylurea (PPT, n = 15) or lispro added to sulfonylurea (PBTS, n = 16). The same dose-adjustment algorithm was used for analyzing both groups; HbA1c, plasma glucose, insulin daily dose, bodyweight and number of hypoglycemic episodes were evaluated.

Results:   At the end of the study, HbA1c was significantly improved in both groups (P < 0.00001), but no difference was apparent between the groups. The daily doses of PPT were more than those of PBTS, albeit the difference was statistically insignificant (P = 0.051). There were significantly fewer hypoglycemic episodes encountered with PPT than with PBTS.

Conclusions:   Thrice-daily injections of lispro 50/50 provide an effective and safe regimen as initial insulin therapy for type 2 diabetes. (J Diabetes Invest, doi: 10.1111/j.2040-1124.2010.00025.x, 2010).

No MeSH data available.


Related in: MedlinePlus

 Study protocol. BG, blood glucose; BMI, body mass index; OAD, oral antidiabetic drugs; NPH, Neutral Protamine Hagedorn insulin; PBTS, prandial bolus therapy with sulfonylurea; PPT, prandial premixed therapy; SU, sulfonylurea.
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f1:  Study protocol. BG, blood glucose; BMI, body mass index; OAD, oral antidiabetic drugs; NPH, Neutral Protamine Hagedorn insulin; PBTS, prandial bolus therapy with sulfonylurea; PPT, prandial premixed therapy; SU, sulfonylurea.

Mentions: The present study was an open‐label, multicentre, observational, parallel study to compare the effect of thrice‐daily lispro 50/50 with thrice daily lispro combined with sulfonylurea as the initial insulin therapy for type 2 diabetes. The study consisted of an initial 12‐week screening period followed by a 24‐week intervention period (Figure 1). Patients visited the clinic every 4 weeks during the study. After the 12‐week screening period, we commenced thrice‐daily insulin injections and divided the 31 patients by turns into either lispro 50/50 with no sulfonylurea (prandial premixed therapy [PPT], n = 15) or lispro plus sulfonylurea (prandial bolus therapy with sulfonylurea [PBTS], n = 16). Patients were allowed to continue biguanides and/or alpha‐glucosidase inhibitors, but were prohibited from changing medications during the study. The initiation dose was 4 units before each meal (12 units per day) for PPT and 3 units before each meal (9 units per day) for PBTS. The sulfonylureas previously prescribed were continued for PBTS, although the dose was decreased to 40 mg for glicrazide, 1 mg for glimepiride, and 2.5 mg for glibenclamide regardless of the dose used in previous therapy, and these doses were not changed during this study. The dose of sulfonylurea at baseline and at 24 weeks, which is shown in Table 1, was indicated as glimepiride. For the conversion of drugs, 40 mg of gliclazide was converted into 1 mg of glimepiride and 2.5 mg of glibenclamide was converted into 2 mg of glimepiride. Baseline uses of sulfonylurea were glimepiride for six patients, glibenclamide for nine patients and gliclazide for one patient in the PPT group. In the PBTS group, baseline uses of sulfonylurea were glimepiride for eight patients, glibenclamide for three patients and gliclazide for four patients.


Comparison of thrice-daily lispro 50/50 vs thrice-daily lispro in combination with sulfonylurea as initial insulin therapy for type 2 diabetes.

Yamashiro K, Ikeda F, Fujitani Y, Watada H, Kawamori R, Hirose T - J Diabetes Investig (2010)

 Study protocol. BG, blood glucose; BMI, body mass index; OAD, oral antidiabetic drugs; NPH, Neutral Protamine Hagedorn insulin; PBTS, prandial bolus therapy with sulfonylurea; PPT, prandial premixed therapy; SU, sulfonylurea.
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC4008007&req=5

f1:  Study protocol. BG, blood glucose; BMI, body mass index; OAD, oral antidiabetic drugs; NPH, Neutral Protamine Hagedorn insulin; PBTS, prandial bolus therapy with sulfonylurea; PPT, prandial premixed therapy; SU, sulfonylurea.
Mentions: The present study was an open‐label, multicentre, observational, parallel study to compare the effect of thrice‐daily lispro 50/50 with thrice daily lispro combined with sulfonylurea as the initial insulin therapy for type 2 diabetes. The study consisted of an initial 12‐week screening period followed by a 24‐week intervention period (Figure 1). Patients visited the clinic every 4 weeks during the study. After the 12‐week screening period, we commenced thrice‐daily insulin injections and divided the 31 patients by turns into either lispro 50/50 with no sulfonylurea (prandial premixed therapy [PPT], n = 15) or lispro plus sulfonylurea (prandial bolus therapy with sulfonylurea [PBTS], n = 16). Patients were allowed to continue biguanides and/or alpha‐glucosidase inhibitors, but were prohibited from changing medications during the study. The initiation dose was 4 units before each meal (12 units per day) for PPT and 3 units before each meal (9 units per day) for PBTS. The sulfonylureas previously prescribed were continued for PBTS, although the dose was decreased to 40 mg for glicrazide, 1 mg for glimepiride, and 2.5 mg for glibenclamide regardless of the dose used in previous therapy, and these doses were not changed during this study. The dose of sulfonylurea at baseline and at 24 weeks, which is shown in Table 1, was indicated as glimepiride. For the conversion of drugs, 40 mg of gliclazide was converted into 1 mg of glimepiride and 2.5 mg of glibenclamide was converted into 2 mg of glimepiride. Baseline uses of sulfonylurea were glimepiride for six patients, glibenclamide for nine patients and gliclazide for one patient in the PPT group. In the PBTS group, baseline uses of sulfonylurea were glimepiride for eight patients, glibenclamide for three patients and gliclazide for four patients.

Bottom Line: Aims/Introduction:  Basal-bolus intensive insulin therapy has been believed to achieve best the glycemic control, but is also complicated as a result of the number of injections required and the type of insulin.The daily doses of PPT were more than those of PBTS, albeit the difference was statistically insignificant (P = 0.051).There were significantly fewer hypoglycemic episodes encountered with PPT than with PBTS.   Thrice-daily injections of lispro 50/50 provide an effective and safe regimen as initial insulin therapy for type 2 diabetes. (J Diabetes Invest, doi: 10.1111/j.2040-1124.2010.00025.x, 2010).

View Article: PubMed Central - PubMed

Affiliation: Department of Medicine, Metabolism and Endocrinology, Juntendo University Graduate School of Medicine.

ABSTRACT

Unlabelled: Aims/Introduction:  Basal-bolus intensive insulin therapy has been believed to achieve best the glycemic control, but is also complicated as a result of the number of injections required and the type of insulin. This study compared the effect of thrice-daily lispro 50/50 (prandial premixed therapy [PPT]) with thrice daily lispro given in combination with sulfonylureas (prandial bolus therapy with sulfonylurea [PBTS]) as initial insulin therapy for type 2 diabetes.

Materials and methods:   This 24-week, observational, parallel trial comprised a 12-week screening period and a 24-week intervention period for 31 diabetes patients who were poorly controlled with submaximal sulfonylurea. At the start of the intervention period, we commenced thrice-daily insulin injections and divided the 31 patients into either lispro 50/50 with discontinuation of sulfonylurea (PPT, n = 15) or lispro added to sulfonylurea (PBTS, n = 16). The same dose-adjustment algorithm was used for analyzing both groups; HbA1c, plasma glucose, insulin daily dose, bodyweight and number of hypoglycemic episodes were evaluated.

Results:   At the end of the study, HbA1c was significantly improved in both groups (P < 0.00001), but no difference was apparent between the groups. The daily doses of PPT were more than those of PBTS, albeit the difference was statistically insignificant (P = 0.051). There were significantly fewer hypoglycemic episodes encountered with PPT than with PBTS.

Conclusions:   Thrice-daily injections of lispro 50/50 provide an effective and safe regimen as initial insulin therapy for type 2 diabetes. (J Diabetes Invest, doi: 10.1111/j.2040-1124.2010.00025.x, 2010).

No MeSH data available.


Related in: MedlinePlus