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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

Mean and variability of FPG levels. The mean (a), SD (c) and CV (e) of FPG levels during the IGlar and IDeg treatment periods were determined for each participant. The two data points for a particular individual were connected by a line. Horizontal bars represent the corresponding mean values for all participants. Box plots of the mean (b), SD (d) and CV (f) of FPG are shown. The line within each box represents the median, and the top and bottom of the box represent the 75th and 25th percentiles, respectively. The whiskers indicate the maximum and minimum values. *p < 0.05. NS, not significant
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Fig2: Mean and variability of FPG levels. The mean (a), SD (c) and CV (e) of FPG levels during the IGlar and IDeg treatment periods were determined for each participant. The two data points for a particular individual were connected by a line. Horizontal bars represent the corresponding mean values for all participants. Box plots of the mean (b), SD (d) and CV (f) of FPG are shown. The line within each box represents the median, and the top and bottom of the box represent the 75th and 25th percentiles, respectively. The whiskers indicate the maximum and minimum values. *p < 0.05. NS, not significant

Mentions: The mean FPG level determined before breakfast during the data collection phase was significantly lower in the IDeg administration period than in the IGlar administration period (7.74 ± 1.76 vs 8.56 ± 2.06 mmol/l; p = 0.04) (Fig. 2a, b). The SD of FPG was also significantly smaller during IDeg administration than during IGlar administration (2.60 ± 0.97 vs 3.19 ± 1.36 mmol/l; p = 0.03) (Fig. 2c, d). The CV of FPG did not, however, differ between the two treatment periods (34.3 ± 13.3 vs 37.1 ± 13.0% for IDeg and IGlar, respectively; p = 0.32) (Fig. 2e, f).Fig. 2


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)

Mean and variability of FPG levels. The mean (a), SD (c) and CV (e) of FPG levels during the IGlar and IDeg treatment periods were determined for each participant. The two data points for a particular individual were connected by a line. Horizontal bars represent the corresponding mean values for all participants. Box plots of the mean (b), SD (d) and CV (f) of FPG are shown. The line within each box represents the median, and the top and bottom of the box represent the 75th and 25th percentiles, respectively. The whiskers indicate the maximum and minimum values. *p < 0.05. NS, not significant
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

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getmorefigures.php?uid=PMC4526586&req=5

Fig2: Mean and variability of FPG levels. The mean (a), SD (c) and CV (e) of FPG levels during the IGlar and IDeg treatment periods were determined for each participant. The two data points for a particular individual were connected by a line. Horizontal bars represent the corresponding mean values for all participants. Box plots of the mean (b), SD (d) and CV (f) of FPG are shown. The line within each box represents the median, and the top and bottom of the box represent the 75th and 25th percentiles, respectively. The whiskers indicate the maximum and minimum values. *p < 0.05. NS, not significant
Mentions: The mean FPG level determined before breakfast during the data collection phase was significantly lower in the IDeg administration period than in the IGlar administration period (7.74 ± 1.76 vs 8.56 ± 2.06 mmol/l; p = 0.04) (Fig. 2a, b). The SD of FPG was also significantly smaller during IDeg administration than during IGlar administration (2.60 ± 0.97 vs 3.19 ± 1.36 mmol/l; p = 0.03) (Fig. 2c, d). The CV of FPG did not, however, differ between the two treatment periods (34.3 ± 13.3 vs 37.1 ± 13.0% for IDeg and IGlar, respectively; p = 0.32) (Fig. 2e, f).Fig. 2

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