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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: assessment of detemir administration in a progressive treat-to-target trial (ADAPT).

ABSTRACT: The purpose of this study was to compare effects of insulin detemir once daily versus twice a day in a basal-bolus insulin regimen.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 <0.4% between groups.A1C at 4 months was 8.1 +/- 0.9 versus 8.0 +/- 1.0% with once- and twice-daily detemir, respectively, with an adjusted between-group difference of 0.12% (95% CI -0.01 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 (-0.4 +/- 0.8 vs. -0.5 +/- 0.8%; P = 0.09, NS) but with differences in the 7-point glucose profile. Detemir doses were lower (29 +/- 18 vs. 39 +/- 20 units/day, P < 0.001), but aspart doses were higher (34 +/- 17 vs. 26 +/- 14 IU/day, P < 0.001) with once-daily detemir. At 7 months, A1C decreased slightly in patients switched from once-daily to twice-daily administration (8.2 +/- 0.8 vs. 8.0 +/- 0.8%; P = 0.34, NS) in association with increased total insulin doses (P < 0.05), but A1C increased in those switched from twice-daily to once-daily administration (7.2 +/- 0.9 vs. 7.6 +/- 0.8%, P < 0.05) in association with decreased doses (P < 0.05).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.

SUBMITTER: Le Floch JP

PROVIDER: S-EPMC2606825 | biostudies-literature | 2009 Jan

REPOSITORIES: biostudies-literature

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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: assessment of detemir administration in a progressive treat-to-target trial (ADAPT).

Le Floch Jean-Pierre JP Lévy Marc M Mosnier-Pudar Helen H Nobels Frank F Laroche Sylvie S Gonbert Sophie S Eschwege Eveline E Fontaine Pierre P

Diabetes care 20081022 1

<h4>Objective</h4>The purpose of this study was to compare effects of insulin detemir once daily versus twice a day in a basal-bolus insulin regimen.<h4>Research design and methods</h4>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 ...[more]

PMID: 18945928

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Project description:IntroductionIn a preceding trial comparing two different titration schemes, insulin degludec/insulin aspart (IDegAsp) showed good efficacy for achieving HbA1c <7% when administered twice daily (BID) in patients with uncontrolled type 2 diabetes (T2D). However, poor glycemic control persisted in a minority of patients. The current exploratory trial investigated the efficacy and safety of intensifying IDegAsp BID treatment in these patients by either adding a once-daily (OD) bolus injection of insulin aspart (IAsp) or by switching to a basal-bolus regimen of insulin degludec (IDeg) plus IAsp taken three times a day (TID).MethodA 26-week, randomized, open-label, phase 3b, treat-to-target trial in which 40 patients with T2D who had not reached target HbA1c ≤7.0% following previous 26-week treatment intensification with IDegAsp BID ±3 oral antidiabetic agents (OADs) were randomized (1:1) to receive IDegAsp BID + IAsp OD (n = 20) or IDeg OD + IAsp TID (n = 20).ResultsMean baseline HbA1c was 7.9% in the IDegAsp BID + IAsp OD group and 7.7% in the IDeg OD + IAsp TID group. After 26 weeks, the estimated mean change in HbA1c from baseline was 0.05% points in the IDegAsp BID + IAsp OD group and -0.49% points for IDeg OD + IAsp TID: estimated treatment difference (ETD) [95% confidence interval] 0.54% [0.09; 0.99], p = 0.021. Few achieved HbA1c <7% in IDegAsp BID + IAsp OD (four patients) and IDeg OD + IAsp TID groups (five patients). Fasting plasma glucose, hypoglycemia, and adverse events were similar between groups.ConclusionWhen used as intensification regimens in patients who failed to achieve target HbA1c during 26-week IDegAsp BID treatment, HbA1c improvements were numerically greater with IDeg OD + IAsp TID compared with IDegAsp BID + IAsp OD. No new safety issues were identified. However, the small, selective sample means clinical generalizations should be made with caution.FundingNovo Nordisk. CLINICALTRIALS.Gov identifierNCT01814137.

Dataset Information

Comparison of once- versus twice-daily administration of insulin detemir, used with mealtime insulin aspart, in basal-bolus therapy for type 1 diabetes: assessment of detemir administration in a progressive treat-to-target trial (ADAPT).

Publications

Comparison of once- versus twice-daily administration of insulin detemir, used with mealtime insulin aspart, in basal-bolus therapy for type 1 diabetes: assessment of detemir administration in a progressive treat-to-target trial (ADAPT).

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