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Changes of HbA1c variability after the switch to a longer-acting insulin analog in people with type 1 diabetes.

ABSTRACT: This study investigated whether longer-acting basal analogs (insulin degludec and insulin glargine U300) could reduce visit-to-visit hemoglobin A1c (HbA1c) variability in patients with type 1 diabetes. Ninety adults with type 1 diabetes for whom the basal insulin was switched to a longer-acting insulin analog were analyzed retrospectively. The coefficient of variation of HbA1c levels (CV-HbA1c) during the year before and after the switch was compared. The CV-HbA1c after the switch was not significantly different from that before the switch (4.39 ± 2.24% vs 4.25 ± 2.07%; P = 0.506). The linear regression model revealed that CV-HbA1c before the switch was independently associated with the change of CV-HbA1c (regression coefficient per standard deviation = -0.568, P < 0.001), whereas the other variables were not (all P > 0.05). In conclusion, CV-HbA1c remained unchanged after the switch on average, but CV-HbA1c before the switch was associated with the decrease of CV-HbA1c in individuals with type 1 diabetes.

SUBMITTER: Watanabe H

PROVIDER: S-EPMC9889620 | biostudies-literature | 2023 Feb

REPOSITORIES: biostudies-literature

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Changes of HbA1c variability after the switch to a longer-acting insulin analog in people with type 1 diabetes.

Watanabe Hirotaka H Takahara Mitsuyoshi M Katakami Naoto N Shimomura Iichiro I

Journal of diabetes investigation 20221107 2

This study investigated whether longer-acting basal analogs (insulin degludec and insulin glargine U300) could reduce visit-to-visit hemoglobin A1c (HbA1c) variability in patients with type 1 diabetes. Ninety adults with type 1 diabetes for whom the basal insulin was switched to a longer-acting insulin analog were analyzed retrospectively. The coefficient of variation of HbA1c levels (CV-HbA1c) during the year before and after the switch was compared. The CV-HbA1c after the switch was not signif ...[more]

PMID: 36345602

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Project description:IntroductionUse of continuous glucose monitoring (CGM) in people with diabetes may provide a more complete picture of glycemic control than glycated hemoglobin (HbA1c) measurements, which do not capture day-to-day fluctuations in blood glucose levels. The randomized, crossover, phase IV SWITCH PRO study assessed time in range (TIR), derived from CGM, following treatment with insulin degludec or insulin glargine U100 in patients with type 2 diabetes at risk for hypoglycemia. This post hoc analysis evaluated the relationship between TIR and HbA1c, following treatment intensification during the SWITCH PRO study.MethodsCorrelation between absolute values for TIR (assessed over 2-week intervals) and HbA1c, at baseline and at the end of maintenance period 1 (M1; week 18) or maintenance period 2 (M2; week 36), were assessed by linear regression and using the Spearman correlation coefficient (rs). These methods were also used to assess correlation between change in TIR and change in HbA1c from baseline to the end of M1, both in the full cohort and in subgroups stratified by baseline median HbA1c (≥ 7.5% [≥ 58.5 mmol/mol] or < 7.5% [< 58.5 mmol/mol]).ResultsA total of 419 participants were included in the analysis. A moderate inverse linear correlation was observed between TIR and HbA1c at baseline (rs -0.54), becoming stronger following treatment intensification during maintenance periods M1 (weeks 17-18: rs -0.59) and M2 (weeks 35-36: rs -0.60). Changes in TIR and HbA1c from baseline to end of M1 were also linearly inversely correlated in the full cohort (rs -0.40) and the subgroup with baseline HbA1c ≥ 7.5% (rs -0.43). This was less apparent in the subgroup with baseline HbA1c < 7.5% (rs -0.17) (p-interaction = 0.07).ConclusionResults from this post hoc analysis of data from SWITCH PRO, one of the first large interventional clinical studies to use TIR as the primary outcome, further support TIR as a valid clinical indicator of glycemic control.Trial registrationClinicalTrials.gov identifier, NCT03687827.

Project description:INTRODUCTION:The aim of this study was to investigate the association between baseline characteristics [HbA1c and body mass index (BMI)] and the effect of mealtime fast-acting insulin aspart (faster aspart) relative to insulin aspart (IAsp) or basal-only insulin therapy on several efficacy and safety outcomes in people with diabetes. METHODS:Post hoc analysis of three randomised phase 3a trials in people with type 1 diabetes (T1D; onset 1) and type 2 diabetes (T2D; onset 2 and 3). Participants (N = 1686) were stratified according to baseline BMI (< 25 kg/m2, 25-< 30 kg/m2, ≥ 30 kg/m2) or HbA1c (≤ 58 mmol/mol, > 58-< 64 mmol/mol, ≥ 64 mmol/mol; ≤ 7.5%, > 7.5-< 8.0%, ≥ 8.0%). RESULTS:In participants with T2D, the estimated treatment difference for change in HbA1c was similar for all BMI and HbA1c subgroups. No major differences between treatments were observed in risk of overall hypoglycaemia or insulin dose across subgroups. In participants with T1D, change in HbA1c was similar across BMI and HbA1c subgroups, and no major differences between treatments were observed for severe or blood glucose-confirmed hypoglycaemia across subgroups. Total daily insulin dose (U/kg) was similar across all baseline HbA1c groups and the BMI < 25 kg/m2 and 25-30 kg/m2 groups, but was significantly lower with mealtime faster aspart compared with IAsp in the BMI > 30 kg/m2 subgroup. CONCLUSIONS:In participants with T1D and T2D, treatment differences (for change in HbA1c and overall hypoglycaemia) between mealtime faster aspart and insulin comparators were similar to the corresponding overall analysis across baseline HbA1c and BMI subgroups. The finding of a lower total daily insulin dose in participants with obesity (BMI > 30 kg/m2) and T1D treated with faster aspart, versus those treated with IAsp, may warrant further investigation. TRIAL REGISTRATION:ClinicalTrials.gov NCT01831765 (onset 1); NCT01819129 (onset 2); NCT01850615 (onset 3). FUNDING:Novo Nordisk A/S, Søborg, Denmark.

Project description:INTRODUCTION:Dapagliflozin is an orally active inhibitor of sodium-glucose co-transporter 2 (SGLT2) that is indicated for use in adults with type 1 diabetes (T1DM) (with a body mass index (BMI) of at least 27 kg/m2 in Europe, no such BMI limit in Japan), when insulin alone does not provide adequate glycaemic control. The aim of this study was to evaluate changes in glycated haemoglobin (HbA1c), body weight and insulin dose following discontinuation of dapagliflozin for the management of T1DM in the DEPICT clinical trial programme. METHODS:The interrelationship between treatment discontinuation, insulin requirement and outcomes post-discontinuation was evaluated using descriptive summary statistics and linear regression modelling. Data were analysed from individuals with T1DM discontinuing dapagliflozin in DEPICT-1 or DEPICT-2 (unplanned or end of study). HbA1c and body weight were measured over the 56-week study period (consisting of a 52-week treatment period and a 4-week follow-up period) at 4-8 weekly intervals. Following discontinuation of dapagliflozin, 1-year change in HbA1c (%) and weight (kg) following discontinuation of dapagliflozin was estimated; total daily insulin doses were descriptively summarised. RESULTS:Of the 1059 individuals that received dapagliflozin during the DEPICT trials 91 met the eligibility criteria and were included in the analyses of HbA1c and body weight. The mean duration of follow-up was 209 days in both analyses. Following dapagliflozin discontinuation, estimated annualised changes in HbA1c and body weight were + 0.99% (95% CI 0.39, 1.59) and + 3.75 kg (1.65, 5.86), respectively. An increase in insulin dose was observed around the time of discontinuation; insulin dose in the 2-week post-discontinuation was + 3.6 IU and + 4.4 IU higher with dapagliflozin 5 mg and 10 mg than 2 weeks pre-discontinuation, respectively. CONCLUSION:Discontinuation of dapagliflozin is predicted to lead to clinically meaningful increases in HbA1c and body weight, in addition to higher insulin doses. These findings are important in the management of people with T1DM among whom insulin is the only existing pharmacological treatment option.

Project description:IntroductionThis study investigated glycaemic control in individuals with type 1 (T1D) or type 2 diabetes (T2D) 6 months after initiating fast-acting insulin aspart (faster aspart) in a real-world setting.MethodsThis was a single-arm, observational study using extracted patient data from the IBM® Explorys® database (USA) for individuals with T1D or T2D initiating faster aspart (at least one prescription of faster aspart) in the study period 1 January 2018 to 27 October 2020. Clinical characteristics, including age, body mass index, and baseline HbA1c, were extracted, as well as recorded events of hypoglycaemia. The primary endpoint was the change in HbA1c from baseline to 6 months.ResultsA total of 787 individuals were included; 36.6% of these individuals had T1D and 63.4% had T2D (of whom 46.9% were new users of rapid-acting insulin when initiating faster aspart [T2D new users] and 53.1% were switching from another rapid-acting insulin to faster aspart [T2D switchers]). For individuals with T1D, T2D new users, or T2D switchers, estimated mean change in HbA1c from baseline to 6 months was - 0.20% (95% CI - 0.53, 0.14; p = 0.252), - 1.00% (95% CI - 1.34, - 0.67; p < 0.0001), and - 0.70% (95% CI - 1.06, - 0.35; p = 0.0001), respectively. In the baseline HbA1c > 8.5% subgroup, there was a significant estimated decrease in HbA1c from baseline to 6 months in individuals with T1D (- 1.2% [95% CI - 1.80, - 0.60]; p = 0.0001) or T2D (- 0.6% [95% CI - 0.92, - 0.35]; p < 0.0001). Event rates of hypoglycaemia after 12 months were 0.68, 0.38, and 0.59 events/year for individuals with T1D, T2D new users, and T2D switchers, respectively.ConclusionUS IBM® Explorys® data demonstrated a clinically relevant reduction in HbA1c 6 months after initiating faster aspart treatment for individuals with T2D, but not T1D overall, although patients with baseline HbA1c > 8.5% had significant HbA1c reductions regardless of diabetes type.

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Changes of HbA1c variability after the switch to a longer-acting insulin analog in people with type 1 diabetes.

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Changes of HbA1c variability after the switch to a longer-acting insulin analog in people with type 1 diabetes.

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