Efficacy of Conversion From Bedtime NPH Insulin Injection to Once- or Twice-Daily Injections of Insulin Glargine in Type 1 Diabetic Patients Using Basal/Bolus Therapy

Albright, Eric S.; Desmond, Reneé A.; Bell, David S.H.

doi:10.2337/diacare.27.2.632

Cited by 74 publications

(67 citation statements)

References 3 publications

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“…2), with glucose tending to be lower before breakfast but rising to higher levels later in the day after oncedaily evening dosing. These observations are again consistent with those described by DeVries et al (11) with regard to studies of insulin glargine (15)(16)(17). As these glycemic profiles depict mean values, the implication is that some individuals will show a more extreme rise in glucose when treated with once-daily detemir, and it might be better for such individuals to be switched to twice-daily dosing.…”

Section: Nonrandomized 4-to 7-month Follow-upsupporting

confidence: 90%

“…As these glycemic profiles depict mean values, the implication is that some individuals will show a more extreme rise in glucose when treated with once-daily detemir, and it might be better for such individuals to be switched to twice-daily dosing. Again, this scenario has been described previously in studies involving insulin glargine (15,17,18).…”

Section: Nonrandomized 4-to 7-month Follow-upsupporting

confidence: 63%

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Comparison of Once- Versus Twice-Daily Administration of Insulin Detemir, Used With Mealtime Insulin Aspart, in Basal-Bolus Therapy for Type 1 Diabetes

Floch¹,

Lévy²,

Mosnier-Pudar³

et al. 2009

Diabetes Care

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OBJECTIVE -The purpose of this study was to compare effects of insulin detemir once daily versus twice a day in a basal-bolus insulin regimen. RESEARCH DESIGN AND METHODS-In this open-label, 7-month study, 520 patients with type 1 diabetes were randomly assigned to receive detemir once daily or twice daily with mealtime insulin aspart. Insulin doses were titrated over 1 month, with patients followed up over the subsequent 3 months. Thereafter, patients were able to switch from one regimen to the other, with an additional nonrandomized 3-month follow-up, to a total of 7 months. The primary end point was A1C at 4 months, with noninferiority defined as a difference Ͻ0.4% between groups.RESULTS -A1C at 4 months was 8.1 Ϯ 0.9 versus 8.0 Ϯ 1.0% with once-and twice-daily detemir, respectively, with an adjusted between-group difference of 0.12% (95% CI Ϫ0.01 to 0.25%), showing noninferiority for once-daily dosing. Similar results were found in the per protocol population. Improvement in A1C was similar in both groups (Ϫ0.4 Ϯ 0.8 vs. Ϫ0.5 Ϯ 0.8%; P ϭ 0.09, NS) but with differences in the 7-point glucose profile. Detemir doses were lower (29 Ϯ 18 vs. 39 Ϯ 20 units/day, P Ͻ 0.001), but aspart doses were higher (34 Ϯ 17 vs. 26 Ϯ 14 IU/day, P Ͻ 0.001) with once-daily detemir. At 7 months, A1C decreased slightly in patients switched from once-daily to twice-daily administration (8.2 Ϯ 0.8 vs. 8.0 Ϯ 0.8%; P ϭ 0.34, NS) in association with increased total insulin doses (P Ͻ 0.05), but A1C increased in those switched from twice-daily to once-daily administration (7.2 Ϯ 0.9 vs. 7.6 Ϯ 0.8%, P Ͻ 0.05) in association with decreased doses (P Ͻ 0.05).CONCLUSIONS -Although some individuals may benefit from twice-daily dosing, the most suitable routine starting schedule for detemir in a basal-bolus regimen for type 1 diabetes is once-daily injection.

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Section: Nonrandomized 4-to 7-month Follow-upsupporting

confidence: 90%

Section: Nonrandomized 4-to 7-month Follow-upsupporting

confidence: 63%

Comparison of Once- Versus Twice-Daily Administration of Insulin Detemir, Used With Mealtime Insulin Aspart, in Basal-Bolus Therapy for Type 1 Diabetes

Floch¹,

Lévy²,

Mosnier-Pudar³

et al. 2009

Diabetes Care

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“…Studies of glargine have reported that twice-daily administration of this basal insulin also tends to increase the dose. 22,23 The post hoc analysis in this trial suggested that similar proportions of patients in the 2 treatment groups met the protocol-defined criterion for a switch from a once-to twice-daily regimen (in the detemir group only). Thus, had this been mandated by the 18 protocol, the proportion of the glargine group completing the trial on a twice-daily regimen would have been similar to that in the detemir group (88.2% and 91.6%, respectively).…”

Section: Discussionmentioning

confidence: 80%

Comparison of insulin detemir and insulin glargine in a basal—bolus regimen, with insulin aspart as the mealtime insulin, in patients with type 1 diabetes: A 52-week, multinational, randomized, open-label, parallel-group, Treat-to-Target noninferiority trial

Heller

Koenen

Bode

2009

Clinical Therapeutics

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Objective: The primary study objective was to determine whether insulin detemir (detemir) was noninferior to insulin glargine (glargine) as the basal insulin in a basalbolus regimen, with insulin aspart as the mealtime insulin, in terms of glycemic control at the end of 52 weeks in patients with type 1 diabetes mellitus (T1DM). Methods:This multinational, open-label, parallel-group, treat-to-target, noninferiority trial enrolled patients aged ≥18 years who had had T1DM for at least 12 months, had been taking a basal-bolus insulin regimen for at least 3 months, and had a glycosylated hemoglobin (HbA 1c ) value ≤11.0%. Patients were randomized in a 2:1 ratio to receive either detemir given once or twice daily or glargine given once daily for 52 weeks. The basal insulin was initially administered once daily (in the evening) in both groups; if patients in the detemir group were achieving the PG target before breakfast but not before dinner, they were switched to twice-daily administration. Each patient attended 13 study visits and received 16 scheduled telephone calls from the trial site.The primary efficacy end point was glycemic control (HbA 1c ) after 52 weeks of treatment. Secondary end points included the number of patients achieving an HbA 1c value ≤7.0%, with or without a major hypoglycemic episode in the last month of treatment; fasting plasma glucose (FPG); within-patient variation in self-monitored plasma glucose (SMPG) before breakfast and dinner; and 10-point SMPG profiles. The noninferiority margin was 0.4%, consistent with US Food and Drug Administration guidelines. significantly between the detemir and glargine groups (7.57% and 7.56%, respectively; mean difference, 0.01%; 95% CI, -0.13 to 0.16), consistent with the noninferiority of detemir to glargine. The corresponding estimated changes in HbA 1c were -0.53% and -0.54%. In the 90 patients who completed the trial on once-daily and the 173 patients who completed the trial on twice-daily detemir, the estimated changes in HbA 1c were -0.45% and -0.56%, respectively. After 52 weeks, there were no significant differences in the proportion of those receiving detemir and glargine who achieved an HbA 1c value ≤7.0% without major hypoglycemia (31.9% and 28.9%, respectively). In addition, there were no significant differences in estimated mean FPG (8.58 and 8.81 mmol/L; mean difference, -0.23; 95% CI,-1.04 to 0.58) or in basal insulin doses. The basal insulin dose was numerically higher in patients receiving detemir twice rather than once daily (0.47 vs 0.33 U/kg, respectively). The relative risks for total and nocturnal hypoglycemia with detemir versus glargine were 0.94 and 1.12, respectively (both, P = NS). Six patients (2.0%) in the detemir group and 4 (2.8%) in the glargine group withdrew due to adverse events. Results Conclusion

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“…25 They found a significant reduction of 0.5% in HbA 1c values at one year. This study has several limitations as well.…”

Section: Discussionmentioning

confidence: 99%

Effect of switching medically vulnerable patients with uncontrolled diabetes from isophane insulin human to insulin glargine

Erickson

Devine

O’Young

et al. 2006

American Journal of Health-System Pharmacy

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Purpose. The purpose of this observational study was to determine if switching from isophane insulin human (NPH) to insulin glargine would improve glycemic control in a medically vulnerable population with uncontrolled diabetes. Methods. A retrospective cohort review of patients' medical records was performed that recorded events occurring between January 1, 2001, and December 31, 2003. The cohort consisted of patients with diabetes in an adult medicine clinic at a county hospital. Patients were included if they were receiving NPH insulin for a minimum of six months and subsequently switched to insulin glargine for a minimum of six months. Results. The study included 43 patients. There was no significant difference in mean glycosylated hemoglobin (HbA 1c ) between NPH insulin (9.6%) and insulin glargine (9.7%) regimens (p = 0.78, 95% confidence interval, -0.62%, 0.82%). Neither was there a significant difference in the frequency or severity of hypoglycemic episodes between the two treatments. Patients experienced significantly fewer diabetesassociated visits over six months while on insulin glargine. Refill frequency did not differ significantly when patients were receiving NPH insulin versus insulin glargine. When analyzing patient characteristics, those of Hispanic ethnicity experienced HbA 1c values significantly higher than white patients. Several characteristics were associated with refill frequency. Conclusion. The results of our study indicate that both NPH-and glargine-based basal insulin regimens result in similar levels of glycemic control in a medically vulnerable population with diabetes, without significant differences in the number or severity of hypoglycemic episodes or in refill frequency.

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Efficacy of Conversion From Bedtime NPH Insulin Injection to Once- or Twice-Daily Injections of Insulin Glargine in Type 1 Diabetic Patients Using Basal/Bolus Therapy

Abstract: Characteristics of patients with type 2 diabetes in Mexico: results from a large populationbased nationwide survey.

Cited by 74 publications

References 3 publications

Comparison of Once- Versus Twice-Daily Administration of Insulin Detemir, Used With Mealtime Insulin Aspart, in Basal-Bolus Therapy for Type 1 Diabetes

Comparison of Once- Versus Twice-Daily Administration of Insulin Detemir, Used With Mealtime Insulin Aspart, in Basal-Bolus Therapy for Type 1 Diabetes

Comparison of insulin detemir and insulin glargine in a basal—bolus regimen, with insulin aspart as the mealtime insulin, in patients with type 1 diabetes: A 52-week, multinational, randomized, open-label, parallel-group, Treat-to-Target noninferiority trial

Effect of switching medically vulnerable patients with uncontrolled diabetes from isophane insulin human to insulin glargine

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