The efficacy and safety of insulin degludec given in variable once-daily dosing intervals compared with insulin glargine and insulin degludec dosed at the same time daily: A 26-week, randomized, open-label, parallel-group, treat-to-target trial in individuals with type 2 diabetes

Luigi Meneghini, Stephen Atkin, Stephen C.L. Gough, Itamar Raz, Lawrence Blonde, Marina Shestakova, Stephen Bain, Thue Johansen, Kamilla Begtrup, Kåre I. Birkeland

Research output: Contribution to journalArticle

172 Citations (Scopus)

Abstract

OBJECTIVE-The requirement to inject current basal insulin analogs at a fixed time each daymay complicate adherence and compromise glycemic control. This trial evaluated the efficacy and safety of varying the daily injection time of insulin degludec (IDeg), an ultra-long-acting basal insulin. RESEARCH DESIGN AND METHODS-This 26-week, open-label, treat-to-target trial enrolled adults (≥18 years) with type 2 diabetes who were either insulin naïve and receiving oral antidiabetic drugs (OADs) (HbA1c = 7-11%) or previously on basal insulin ± OAD(s) (HbA1c = 7-10%). Participants were randomized to 1) once-daily (OD) IDeg in a prespecified dosing schedule, creating 8-40-h intervals between injections (IDeg OD Flex; n = 229); 2) once-daily IDeg at the main evening meal (IDegOD; n = 228); or 3) once-daily insulin glargine at the same time each day (IGlarOD; n = 230). The primary outcomewas noninferiority of IDegODFlex to IGlarODinHbA1c reduction after 26 weeks. RESULTS-After 26 weeks, IDeg OD Flex, IDeg OD, and IGlar OD improved HbA1c by 1.28, 1.07, and 1.26% points, respectively (estimated treatment difference [IDeg OD Flex 2 IGlar OD]: 0.04% points [-0.12 to 0.20], confirming noninferiority). No statistically significant differences in overall or nocturnal hypoglycemia were found between IDeg OD Flex and IGlar OD. Comparable glycemic control and rates of hypoglycemia were seen with IDeg OD Flex and IDeg OD. Adverse event profiles were similar across groups. CONCLUSIONS-The use of extreme dosing intervals of 8-40 h demonstrates that the daily injection time of IDeg can be varied without compromising glycemic control or safety.

Original languageEnglish
Pages (from-to)858-864
Number of pages7
JournalDiabetes Care
Volume36
Issue number4
DOIs
Publication statusPublished - Apr 2013
Externally publishedYes

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faropenem medoxomil
Type 2 Diabetes Mellitus
Safety
Insulin
Hypoglycemia
Hypoglycemic Agents
Injections
Insulin Glargine
insulin degludec
Long-Acting Insulin
Meals
Appointments and Schedules
Research Design

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Advanced and Specialised Nursing

Cite this

The efficacy and safety of insulin degludec given in variable once-daily dosing intervals compared with insulin glargine and insulin degludec dosed at the same time daily : A 26-week, randomized, open-label, parallel-group, treat-to-target trial in individuals with type 2 diabetes. / Meneghini, Luigi; Atkin, Stephen; Gough, Stephen C.L.; Raz, Itamar; Blonde, Lawrence; Shestakova, Marina; Bain, Stephen; Johansen, Thue; Begtrup, Kamilla; Birkeland, Kåre I.

In: Diabetes Care, Vol. 36, No. 4, 04.2013, p. 858-864.

Research output: Contribution to journalArticle

Meneghini, Luigi ; Atkin, Stephen ; Gough, Stephen C.L. ; Raz, Itamar ; Blonde, Lawrence ; Shestakova, Marina ; Bain, Stephen ; Johansen, Thue ; Begtrup, Kamilla ; Birkeland, Kåre I. / The efficacy and safety of insulin degludec given in variable once-daily dosing intervals compared with insulin glargine and insulin degludec dosed at the same time daily : A 26-week, randomized, open-label, parallel-group, treat-to-target trial in individuals with type 2 diabetes. In: Diabetes Care. 2013 ; Vol. 36, No. 4. pp. 858-864.
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abstract = "OBJECTIVE-The requirement to inject current basal insulin analogs at a fixed time each daymay complicate adherence and compromise glycemic control. This trial evaluated the efficacy and safety of varying the daily injection time of insulin degludec (IDeg), an ultra-long-acting basal insulin. RESEARCH DESIGN AND METHODS-This 26-week, open-label, treat-to-target trial enrolled adults (≥18 years) with type 2 diabetes who were either insulin na{\"i}ve and receiving oral antidiabetic drugs (OADs) (HbA1c = 7-11{\%}) or previously on basal insulin ± OAD(s) (HbA1c = 7-10{\%}). Participants were randomized to 1) once-daily (OD) IDeg in a prespecified dosing schedule, creating 8-40-h intervals between injections (IDeg OD Flex; n = 229); 2) once-daily IDeg at the main evening meal (IDegOD; n = 228); or 3) once-daily insulin glargine at the same time each day (IGlarOD; n = 230). The primary outcomewas noninferiority of IDegODFlex to IGlarODinHbA1c reduction after 26 weeks. RESULTS-After 26 weeks, IDeg OD Flex, IDeg OD, and IGlar OD improved HbA1c by 1.28, 1.07, and 1.26{\%} points, respectively (estimated treatment difference [IDeg OD Flex 2 IGlar OD]: 0.04{\%} points [-0.12 to 0.20], confirming noninferiority). No statistically significant differences in overall or nocturnal hypoglycemia were found between IDeg OD Flex and IGlar OD. Comparable glycemic control and rates of hypoglycemia were seen with IDeg OD Flex and IDeg OD. Adverse event profiles were similar across groups. CONCLUSIONS-The use of extreme dosing intervals of 8-40 h demonstrates that the daily injection time of IDeg can be varied without compromising glycemic control or safety.",
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T1 - The efficacy and safety of insulin degludec given in variable once-daily dosing intervals compared with insulin glargine and insulin degludec dosed at the same time daily

T2 - A 26-week, randomized, open-label, parallel-group, treat-to-target trial in individuals with type 2 diabetes

AU - Meneghini, Luigi

AU - Atkin, Stephen

AU - Gough, Stephen C.L.

AU - Raz, Itamar

AU - Blonde, Lawrence

AU - Shestakova, Marina

AU - Bain, Stephen

AU - Johansen, Thue

AU - Begtrup, Kamilla

AU - Birkeland, Kåre I.

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N2 - OBJECTIVE-The requirement to inject current basal insulin analogs at a fixed time each daymay complicate adherence and compromise glycemic control. This trial evaluated the efficacy and safety of varying the daily injection time of insulin degludec (IDeg), an ultra-long-acting basal insulin. RESEARCH DESIGN AND METHODS-This 26-week, open-label, treat-to-target trial enrolled adults (≥18 years) with type 2 diabetes who were either insulin naïve and receiving oral antidiabetic drugs (OADs) (HbA1c = 7-11%) or previously on basal insulin ± OAD(s) (HbA1c = 7-10%). Participants were randomized to 1) once-daily (OD) IDeg in a prespecified dosing schedule, creating 8-40-h intervals between injections (IDeg OD Flex; n = 229); 2) once-daily IDeg at the main evening meal (IDegOD; n = 228); or 3) once-daily insulin glargine at the same time each day (IGlarOD; n = 230). The primary outcomewas noninferiority of IDegODFlex to IGlarODinHbA1c reduction after 26 weeks. RESULTS-After 26 weeks, IDeg OD Flex, IDeg OD, and IGlar OD improved HbA1c by 1.28, 1.07, and 1.26% points, respectively (estimated treatment difference [IDeg OD Flex 2 IGlar OD]: 0.04% points [-0.12 to 0.20], confirming noninferiority). No statistically significant differences in overall or nocturnal hypoglycemia were found between IDeg OD Flex and IGlar OD. Comparable glycemic control and rates of hypoglycemia were seen with IDeg OD Flex and IDeg OD. Adverse event profiles were similar across groups. CONCLUSIONS-The use of extreme dosing intervals of 8-40 h demonstrates that the daily injection time of IDeg can be varied without compromising glycemic control or safety.

AB - OBJECTIVE-The requirement to inject current basal insulin analogs at a fixed time each daymay complicate adherence and compromise glycemic control. This trial evaluated the efficacy and safety of varying the daily injection time of insulin degludec (IDeg), an ultra-long-acting basal insulin. RESEARCH DESIGN AND METHODS-This 26-week, open-label, treat-to-target trial enrolled adults (≥18 years) with type 2 diabetes who were either insulin naïve and receiving oral antidiabetic drugs (OADs) (HbA1c = 7-11%) or previously on basal insulin ± OAD(s) (HbA1c = 7-10%). Participants were randomized to 1) once-daily (OD) IDeg in a prespecified dosing schedule, creating 8-40-h intervals between injections (IDeg OD Flex; n = 229); 2) once-daily IDeg at the main evening meal (IDegOD; n = 228); or 3) once-daily insulin glargine at the same time each day (IGlarOD; n = 230). The primary outcomewas noninferiority of IDegODFlex to IGlarODinHbA1c reduction after 26 weeks. RESULTS-After 26 weeks, IDeg OD Flex, IDeg OD, and IGlar OD improved HbA1c by 1.28, 1.07, and 1.26% points, respectively (estimated treatment difference [IDeg OD Flex 2 IGlar OD]: 0.04% points [-0.12 to 0.20], confirming noninferiority). No statistically significant differences in overall or nocturnal hypoglycemia were found between IDeg OD Flex and IGlar OD. Comparable glycemic control and rates of hypoglycemia were seen with IDeg OD Flex and IDeg OD. Adverse event profiles were similar across groups. CONCLUSIONS-The use of extreme dosing intervals of 8-40 h demonstrates that the daily injection time of IDeg can be varied without compromising glycemic control or safety.

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