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Incidence of Hypoglycaemia in Patients with Type 2 Diabetes - A Subgroup Analysis from the GINGER study.

ABSTRACT: Introduction: The Glulisine in Combination with Insulin Glargine in an Intensified Insulin Regimen (GINGER) study compared insulin glargine plus insulin glulisine with premixed insulin in the treatment of patients with Type 2 diabetes mellitus (T2DM). This was a post-hoc analysis of hypoglycaemia rates in subgroups from the GINGER study. Methods: This analysis compared the once-daily glargine plus mealtime glulisine group (n=153, four injections/day) with the overall twice-daily premixed insulin group (n=157, two injections/day), which consisted of two subgroups receiving either neutral protamine Hagedorn (NPH) plus regular insulin (n=93) or biphasic insulin aspart 70/30 (n=63). Observed and predicted hypoglycaemia rates relative to endpoint HbA1c for both the total population and those patients who experienced ?1 episodes of any hypoglycaemia were estimated. Results: The overall hypoglycaemic event rate (episodes per patient-year) for patients receiving glargine plus glulisine was numerically but not significantly lower (-24.5 %) compared with the overall premixed insulin group (14.0±24.2 versus 18.5±36.9; p=0.12) and significantly lower (-43.3 %) compared with the biphasic insulin aspart 70/30 subgroup (24.7±48.5; p=0.02). In patients with ?1 episode of hypoglycaemia during treatment, the overall hypoglycaemic event rate was significantly lower (-26.5 %) in patients receiving glargine plus glulisine versus overall premixed insulin (18.5±26.3 versus 25.1±41.1; p=0.044) and significantly lower (-40.7 %) than in patients receiving biphasic insulin aspart 70/30 (31.1±52.7; p=0.009). Glargine/glulisine treatment maintained a more consistent and numerically lower hypoglycaemia rate at all achieved HbA1c endpoints compared with premixed insulin treatment. Conclusion: This post-hoc analysis of the GINGER study showed that the frequency of hypoglycaemia in T2DM patients was lowered to a greater extent by insulin glargine plus insulin glulisine in a comparison with premixed biphasic insulin aspart 70/30 than was previously shown in a comparison with overall premixed insulin. Trial Identifier: NCT00174668.

SUBMITTER: Fritsche A

PROVIDER: S-EPMC6193515 | biostudies-literature | 2013 Mar

REPOSITORIES: biostudies-literature

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Incidence of Hypoglycaemia in Patients with Type 2 Diabetes - A Subgroup Analysis from the GINGER study.

Fritsche Andreas A Hahn Almut A Landgraf Wolfgang W Häring Hans-Ulrich HU

European endocrinology 20130301 1

<b>Introduction:</b> The Glulisine in Combination with Insulin Glargine in an Intensified Insulin Regimen (GINGER) study compared insulin glargine plus insulin glulisine with premixed insulin in the treatment of patients with Type 2 diabetes mellitus (T2DM). This was a post-hoc analysis of hypoglycaemia rates in subgroups from the GINGER study. <b>Methods:</b> This analysis compared the once-daily glargine plus mealtime glulisine group (n=153, four injections/day) with the overall twice-daily pr ...[more]

PMID: 30349602

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Project description:BackgroundHypoglycaemia is a common and potentially avoidable adverse event in people with type 2 diabetes (T2D). It can reduce quality of life, increase healthcare costs, and reduce treatment success. We investigated self-management issues associated with hypoglycaemia and self-identified causes of hypoglycaemia in these patients.MethodsIn this mixed methods study qualitative semi-structured interviews were performed, which informed a subsequent quantitative survey in T2D patients. All interviews were audio recorded, transcribed verbatim and coded independently by two coders using directed content analysis, guided by the Theoretical Domains Framework. Descriptive statistics were used to quantify the self-management issues and causes of hypoglycaemia collected in the survey for the respondents that had experienced at least one hypoglycaemic event in the past.ResultsSixteen participants were interviewed, aged 59-84 years. Participants perceived difficulties in managing deviations from routine, and they sometimes lacked procedural knowledge to adjust medication, nutrition or physical activity to manage their glucose levels. Grief and loss of support due to the loss of a partner interfered with self-management and lead to hypoglycaemic events. Work ethic lead some participant to overexerting themselves, which in turn lead to hypoglycaemic events. The participants had difficulties preventing hypoglycaemic events, because they did not know the cause, suffered from impaired hypoglycaemia awareness and/or did not want to regularly measure their blood glucose. When they did recognise a cause, they identified issues with nutrition, physical activity, stress or medication. In total, 40% of respondents reported regular stress as an issue, 24% reported that they regularly overestimated their physical abilities, and 22% indicated they did not always know how to adjust their medication. Around 16% of patients could not always remember whether they took their medication, and 42% always took their medication at regular times. Among the 83 respondents with at least one hypoglycaemic event, common causes for hypoglycaemia mentioned were related to physical activity (67%), low food intake (52%), deviations from routine (35%) and emotional burden (28%). Accidental overuse of medication was reported by 10%.ConclusionPeople with T2D experience various issues with self-managing their glucose levels. This study underlines the importance of daily routine and being able to adjust medication in relation to more physical activity or less food intake as well as the ability to reduce and manage stress to prevent hypoglycaemic events.

Project description:ObjectiveCopeptin, a marker for stress mirroring vasopressin concentrations, has been shown to increase upon insulin-induced hypoglycaemia in patients after transsphenoidal surgery of pituitary adenomas. Patients with type 1 diabetes mellitus are prone to hypoglycaemia, but no data about copeptin levels upon hypoglycaemia are available. Furthermore, the perception of hypoglycaemia can vary from total unawareness to disabling episodes. The aim of this study was to investigate whether copeptin increases upon hypoglycaemia in patients with type 1 diabetes mellitus and is associated with the degree of hypoglycaemia awareness.Materials and methodsIn this prospective observational study, 17 patients with type 1 diabetes underwent a standardized insulin infusion test. Blood sampling for glucose and copeptin was performed at baseline and after 60 minutes (min). To assess hypoglycaemia associated symptoms the Mood and Symptom Questionnaire (MSQ) was conducted at baseline and after 60 min.ResultsDuring insulin infusion, blood glucose decreased from 5.1 (SD±0.2) to 3.0 (±0.5) mmol/L at 60 min (p<0.001). Copeptin concentrations increased from 3.2 (±1.7) to 3.8 (±1.9) pmol/L (p = 0.03). Mood and Symptoms Questionnaire scores increased from 14 (±3.0) to 18 (±5.8), (p = 0.006). Patients with good hypoglycaemia awareness had an increase in copeptin from 3.0 (±1.8) to 4.2 (±2.4) pmol/L (p = 0.03) in contrast to patients more unaware of hypoglycaemia who only showed an increase in copeptin from 3.3 (±1.6) to 3.6 (±1.4) pmol/L (p = 0.4). There was a trend to a larger copeptin increase in patients aware of hypoglycemia compared to patients unaware of hypoglycemia (p = 0.074).ConclusionCopeptin increases in patients with type 1 diabetes upon insulin induced hypoglycaemia. Interestingly, the copeptin increase seems associated with the degree of hypoglycaemia awareness. This hypothesis warrants further verification.Trial registrationClinicalTrials.gov NCT00515801.

Project description:ObjectiveTo determine whether there is a link between hypoglycaemia and mortality among participants in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial.DesignRetrospective epidemiological analysis of data from the ACCORD trial. Setting Diabetes clinics, research clinics, and primary care clinics.ParticipantsPatients were eligible for the ACCORD study if they had type 2 diabetes, a glycated haemoglobin (haemoglobin A(1C)) concentration of 7.5% or more during screening, and were aged 40-79 years with established cardiovascular disease or 55-79 years with evidence of subclinical disease or two additional cardiovascular risk factors. Intervention Intensive (haemoglobin A(1C) <6.0%) or standard (haemoglobin A(1C) 7.0-7.9%) glucose control.Outcome measuresSymptomatic, severe hypoglycaemia, manifest as either blood glucose concentration of less than 2.8 mmol/l (<50 mg/dl) or symptoms that resolved with treatment and that required either the assistance of another person or medical assistance, and all cause and cause specific mortality, including a specific assessment for involvement of hypoglycaemia.Results10 194 of the 10 251 participants enrolled in the ACCORD study who had at least one assessment for hypoglycaemia during regular follow-up for vital status were included in this analysis. Unadjusted annual mortality among patients in the intensive glucose control arm was 2.8% in those who had one or more episodes of hypoglycaemia requiring any assistance compared with 1.2% for those with no episodes (53 deaths per 1924 person years and 201 deaths per 16 315 person years, respectively; adjusted hazard ratio (HR) 1.41, 95% CI 1.03 to 1.93). A similar pattern was seen among participants in the standard glucose control arm (3.7% (21 deaths per 564 person years) v 1.0% (176 deaths per 17 297 person years); adjusted HR 2.30, 95% CI 1.46 to 3.65). On the other hand, among participants with at least one hypoglycaemic episode requiring any assistance, a non-significantly lower risk of death was seen in those in the intensive arm compared with those in the standard arm (adjusted HR 0.74, 95% 0.46 to 1.23). A significantly lower risk was observed in the intensive arm compared with the standard arm in participants who had experienced at least one hypoglycaemic episode requiring medical assistance (adjusted HR 0.55, 95% CI 0.31 to 0.99). Of the 451 deaths that occurred in ACCORD up to the time when the intensive treatment arm was closed, one death was adjudicated as definitely related to hypoglycaemia.ConclusionSymptomatic, severe hypoglycaemia was associated with an increased risk of death within each study arm. However, among participants who experienced at least one episode of hypoglycaemia, the risk of death was lower in such participants in the intensive arm than in the standard arm. Symptomatic, severe hypoglycaemia does not appear to account for the difference in mortality between the two study arms up to the time when the ACCORD intensive glycaemia arm was discontinued.Trial registrationNCT00000620.

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Incidence of Hypoglycaemia in Patients with Type 2 Diabetes - A Subgroup Analysis from the GINGER study.

Publications

Incidence of Hypoglycaemia in Patients with Type 2 Diabetes - A Subgroup Analysis from the GINGER study.

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