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Effects of insulin degludec and insulin glargine on day-to-day fasting plasma glucose variability in individuals with type 1 diabetes: a multicentre, randomised, crossover study.

Nakamura T, Sakaguchi K, So A, Nakajima S, Takabe M, Komada H, Okuno Y, Hirota Y, Nakamura T, Iida K, Kajikawa M, Nagata M, Ogawa W, Seino S - Diabetologia (2015)

Bottom Line: The dose of IDeg was smaller than that of IGlar (11.0 ± 5.2 vs 11.8 ± 5.6 U/day; p < 0.01), but other secondary endpoints did not differ between the treatments.University Hospital Medical Information Network 000009965.This research recieved no specific grant from any funding agency in the public, commercial or not-for-profit sectors.

View Article: PubMed Central - PubMed

Affiliation: Division of Diabetes and Endocrinology, Department of Internal Medicine, Kobe University Graduate School of Medicine, 7-5-1 Kusunoki-cho, Chuo-ku, Kobe, 650-0017, Japan.

ABSTRACT

Aims/hypothesis: We compared the effects of insulin degludec (IDeg; Des(B30)LysB29(γ-Glu Nε-hexadecandioyl) human insulin) and insulin glargine (IGlar; A21Gly,B31Arg,B32Arg human insulin) on the day-to-day variability of fasting plasma glucose (FPG) levels in individuals with type 1 diabetes treated with basal-bolus insulin injections.

Methods: The effects of basal-bolus insulin therapy for 4 weeks with either IDeg or IGlar as the basal insulin in adult C-peptide-negative outpatients with type 1 diabetes were investigated in an open-label, multicentre, randomised, crossover trial. Randomisation was conducted using a centralised allocation process. The primary endpoints were the SD and CV of FPG during the final week of each treatment period. Secondary endpoints included serum glycoalbumin level, daily dose of insulin, intraday glycaemic variability and frequency of severe hypoglycaemia.

Results: Thirty-six randomised participants (17 in the IDeg/IGlar and 19 in the IGlar/IDeg groups) were recruited, and data for 32 participants who completed the trial were analysed. The mean (7.74 ± 1.76 vs 8.56 ± 2.06 mmol/l; p = 0.04) and SD (2.60 ± 0.97 vs 3.19 ± 1.36 mmol/l; p = 0.03) of FPG were lower during IDeg treatment than during IGlar treatment, whereas the CV did not differ between the two treatments. The dose of IDeg was smaller than that of IGlar (11.0 ± 5.2 vs 11.8 ± 5.6 U/day; p < 0.01), but other secondary endpoints did not differ between the treatments.

Conclusions/interpretation: IDeg yielded a lower FPG level and smaller day-to-day variability of FPG at a lower daily dose compared with IGlar in participants with type 1 diabetes. IDeg serves as a good option for basal insulin in the treatment of type 1 diabetes.

Trial registration: University Hospital Medical Information Network 000009965.

Funding: This research recieved no specific grant from any funding agency in the public, commercial or not-for-profit sectors.

No MeSH data available.


Related in: MedlinePlus

Study design. Eligible patients were randomly allocated to the IGlar/IDeg group (upper arm) or the IDeg/IGlar group (lower arm). In the IGlar/IDeg group, the basal insulin was switched after 4 weeks from IGlar to IDeg, whereas in the IDeg/IGlar group the basal insulin was switched after 4 weeks from IDeg to IGlar. The last week of each treatment period constituted the data collection phase in which seven SMBG measurements per day were performed and the insulin dosage was determined. The serum glycoalbumin level was also measured on the last day of each treatment period
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Fig1: Study design. Eligible patients were randomly allocated to the IGlar/IDeg group (upper arm) or the IDeg/IGlar group (lower arm). In the IGlar/IDeg group, the basal insulin was switched after 4 weeks from IGlar to IDeg, whereas in the IDeg/IGlar group the basal insulin was switched after 4 weeks from IDeg to IGlar. The last week of each treatment period constituted the data collection phase in which seven SMBG measurements per day were performed and the insulin dosage was determined. The serum glycoalbumin level was also measured on the last day of each treatment period

Mentions: Individuals found to satisfy the criteria were randomly assigned to the IGlar (first period)/IDeg (second period) (IGlar/IDeg) or the IDeg (first period)/IGlar (second period) (IDeg/IGlar) group by a centralised allocation process. In the IGlar/IDeg group, the basal insulin was switched after 4 weeks from IGlar (Lantus, SoloSTAR; Sanofi, Paris, France) to IDeg (Tresiba, FlexTouch; Novo Nordisk, Bagsvaerd, Denmark). In the IDeg/IGlar group, the basal insulin was switched after 4 weeks from IDeg to IGlar. The participants were directed to determine their plasma glucose level four times a day (before breakfast, lunch and dinner as well as at bedtime) by SMBG during the entire trial period. The last week of each treatment period constituted the data collection phase, during which the participants were directed to determine their plasma glucose level seven times a day (before breakfast, 2 h after breakfast, before lunch, 2 h after lunch, before dinner, 2 h after dinner and at bedtime) (Fig. 1). All individuals were provided with the same device (OneTouch Ultra; Johnson & Johnson, New Brunswick, NJ) and directed to perform blood testing with it. Given that the measurements of the SMBG device are calibrated to the plasma glucose concentrations, we considered the values recorded by this device as the plasma glucose levels. The serum glycoalbumin level was measured at the end of each treatment period.Fig. 1


Effects of insulin degludec and insulin glargine on day-to-day fasting plasma glucose variability in individuals with type 1 diabetes: a multicentre, randomised, crossover study.

Nakamura T, Sakaguchi K, So A, Nakajima S, Takabe M, Komada H, Okuno Y, Hirota Y, Nakamura T, Iida K, Kajikawa M, Nagata M, Ogawa W, Seino S - Diabetologia (2015)

Study design. Eligible patients were randomly allocated to the IGlar/IDeg group (upper arm) or the IDeg/IGlar group (lower arm). In the IGlar/IDeg group, the basal insulin was switched after 4 weeks from IGlar to IDeg, whereas in the IDeg/IGlar group the basal insulin was switched after 4 weeks from IDeg to IGlar. The last week of each treatment period constituted the data collection phase in which seven SMBG measurements per day were performed and the insulin dosage was determined. The serum glycoalbumin level was also measured on the last day of each treatment period
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC4526586&req=5

Fig1: Study design. Eligible patients were randomly allocated to the IGlar/IDeg group (upper arm) or the IDeg/IGlar group (lower arm). In the IGlar/IDeg group, the basal insulin was switched after 4 weeks from IGlar to IDeg, whereas in the IDeg/IGlar group the basal insulin was switched after 4 weeks from IDeg to IGlar. The last week of each treatment period constituted the data collection phase in which seven SMBG measurements per day were performed and the insulin dosage was determined. The serum glycoalbumin level was also measured on the last day of each treatment period
Mentions: Individuals found to satisfy the criteria were randomly assigned to the IGlar (first period)/IDeg (second period) (IGlar/IDeg) or the IDeg (first period)/IGlar (second period) (IDeg/IGlar) group by a centralised allocation process. In the IGlar/IDeg group, the basal insulin was switched after 4 weeks from IGlar (Lantus, SoloSTAR; Sanofi, Paris, France) to IDeg (Tresiba, FlexTouch; Novo Nordisk, Bagsvaerd, Denmark). In the IDeg/IGlar group, the basal insulin was switched after 4 weeks from IDeg to IGlar. The participants were directed to determine their plasma glucose level four times a day (before breakfast, lunch and dinner as well as at bedtime) by SMBG during the entire trial period. The last week of each treatment period constituted the data collection phase, during which the participants were directed to determine their plasma glucose level seven times a day (before breakfast, 2 h after breakfast, before lunch, 2 h after lunch, before dinner, 2 h after dinner and at bedtime) (Fig. 1). All individuals were provided with the same device (OneTouch Ultra; Johnson & Johnson, New Brunswick, NJ) and directed to perform blood testing with it. Given that the measurements of the SMBG device are calibrated to the plasma glucose concentrations, we considered the values recorded by this device as the plasma glucose levels. The serum glycoalbumin level was measured at the end of each treatment period.Fig. 1

Bottom Line: The dose of IDeg was smaller than that of IGlar (11.0 ± 5.2 vs 11.8 ± 5.6 U/day; p < 0.01), but other secondary endpoints did not differ between the treatments.University Hospital Medical Information Network 000009965.This research recieved no specific grant from any funding agency in the public, commercial or not-for-profit sectors.

View Article: PubMed Central - PubMed

Affiliation: Division of Diabetes and Endocrinology, Department of Internal Medicine, Kobe University Graduate School of Medicine, 7-5-1 Kusunoki-cho, Chuo-ku, Kobe, 650-0017, Japan.

ABSTRACT

Aims/hypothesis: We compared the effects of insulin degludec (IDeg; Des(B30)LysB29(γ-Glu Nε-hexadecandioyl) human insulin) and insulin glargine (IGlar; A21Gly,B31Arg,B32Arg human insulin) on the day-to-day variability of fasting plasma glucose (FPG) levels in individuals with type 1 diabetes treated with basal-bolus insulin injections.

Methods: The effects of basal-bolus insulin therapy for 4 weeks with either IDeg or IGlar as the basal insulin in adult C-peptide-negative outpatients with type 1 diabetes were investigated in an open-label, multicentre, randomised, crossover trial. Randomisation was conducted using a centralised allocation process. The primary endpoints were the SD and CV of FPG during the final week of each treatment period. Secondary endpoints included serum glycoalbumin level, daily dose of insulin, intraday glycaemic variability and frequency of severe hypoglycaemia.

Results: Thirty-six randomised participants (17 in the IDeg/IGlar and 19 in the IGlar/IDeg groups) were recruited, and data for 32 participants who completed the trial were analysed. The mean (7.74 ± 1.76 vs 8.56 ± 2.06 mmol/l; p = 0.04) and SD (2.60 ± 0.97 vs 3.19 ± 1.36 mmol/l; p = 0.03) of FPG were lower during IDeg treatment than during IGlar treatment, whereas the CV did not differ between the two treatments. The dose of IDeg was smaller than that of IGlar (11.0 ± 5.2 vs 11.8 ± 5.6 U/day; p < 0.01), but other secondary endpoints did not differ between the treatments.

Conclusions/interpretation: IDeg yielded a lower FPG level and smaller day-to-day variability of FPG at a lower daily dose compared with IGlar in participants with type 1 diabetes. IDeg serves as a good option for basal insulin in the treatment of type 1 diabetes.

Trial registration: University Hospital Medical Information Network 000009965.

Funding: This research recieved no specific grant from any funding agency in the public, commercial or not-for-profit sectors.

No MeSH data available.


Related in: MedlinePlus