Predictors of Response to Early Basal Insulin Treatment in Patients with Type 2 Diabetes—The EARLY Experience

Hanefeld, Markolf; Fleischmann, Holger; Schiffhorst, G.; Bramlage, Peter

doi:10.1089/dia.2013.0246

Cited by 19 publications

(20 citation statements)

References 17 publications

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“…Although only a small difference in mean HbA1c existed between groups at baseline, lower baseline HbA1c was still identified as a strong, independent predictor of response at 12 months. This finding appears to be consistent across patients initiating a range of insulin types . Higher FBG at baseline may also suggest a probable lack of response, athough the effect size is smaller and less clinically applicable.…”

Section: Discussionsupporting

confidence: 60%

Predictors of treatment response in type‐2 diabetes patients initiating basal‐supported oral therapy with insulin glargine 100 U/mL: A sub‐analysis of the Titration and OPtimisation (TOP) registry

Pfohl

Pscherer

Fritsche

et al. 2019

Diabetes Obesity Metabolism

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The aim of this study was to identify predictors of long-term response to the initiation of basal-supported oral therapy (BOT) with insulin glargine (IGlar-100). Patients from the observational TOP registry were grouped based on those who had achieved (responders) and those who had not achieved (non-responders) their HBA1c target and/or FBG ≤110 mg/dL 12 months after IGlar-100 initiation. Independent predictors of treatment response were identified by regression analysis. Data for 2444 patients were analysed (responders, n = 1610; non-responders, n = 834). Although the IGlar-100 dose increase over 12 months was larger for non-responders (+12.83 vs +9.46 U/d; P < 0.0001), the corresponding decrease in HbA1c was smaller (−0.88% vs −1.57%). Independent predictors of response included lower BMI (OR, 0.97; 95% CI, 0.95-1.00), lower FBG (OR, 0.98; 95% CI, 0.97-0.98) and HbA1c values at baseline (OR, 0.24; 95% CI, 0.18-0.31), a less ambitious HbA1c target (OR, 5.07; 95% CI, 3.37-7.63) and bedtime administration of IGlar-100 (OR, 1.55; 95% CI, 1.12-2.14). In conclusion, HbA1c was the clinically most significant baseline characteristic predictive of response to BOT. This may suggest an advantage of IGlar-100 initiation prior to excessive hyperglycaemia escalation.basal, basal-supported oral therapy, hypoglycaemia, insulin glargine, response duration, 6 lower body weight 5 and older age 7 at the time of insulin initiation. The ALOHA2 study of Japanese patients initiating BOT with insulin glargine 100 U/mL (IGlar-100) found achievement of HbA1c of 7% (53 mmol/mol) or less at 6 months to be associated with a shorter diabetes duration and lower HbA1c prior to insulin introduction. 8The primary aim of the present TOP sub-analysis was to compare the characteristics and therapeutic management of responders to those of non-responders and to identify predictors of long-term response to BOT with IGlar-100 in a German population. | METHODS | Study designThe methodology of the prospective, observational TOP registry has been described previously. 9 The registry gathered data on patients with inadequately controlled T2DM who were initiating IGlar-100 BOT at German general practices between October 2013 and October 2015. Registry approval was provided by the relevant local ethics committees. Written informed consent to participate was given by all patients. | DocumentationPatient demographics, current HbA1c and FBG levels, and details of antidiabetic medication (OADs or insulin) were recorded at baseline, defined as the day of IGlar-100 initiation. Physicians assigned each patient an individual HbA1c target at this time, independently of study participation.Any IGlar-100 titrations or changes to basal insulin, that is, switching to a different type, that occurred between baseline and the end of the 12-month follow-up period were recorded, with HbA1c and FBG measurements documented at regular intervals. Any episodes of hypoglycaemia were also detailed and categorised as: symptomatic; symptomatic and confirmed (blood glucose ≤70 mg/dL); ...

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Section: Discussionsupporting

confidence: 60%

Predictors of treatment response in type‐2 diabetes patients initiating basal‐supported oral therapy with insulin glargine 100 U/mL: A sub‐analysis of the Titration and OPtimisation (TOP) registry

Pfohl

Pscherer

Fritsche

et al. 2019

Diabetes Obesity Metabolism

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“…The ORIGIN study [17], which is an example of early insulin treatment, showed that people receiving insulin glargine typically required fewer additional antidiabetic agents at the end of the study than those receiving standard care. Although we cannot find similar studies designed like ours, several studies showed that people with lower HbA1c levels at baseline, lower body mass index (BMI) and shorter duration of T2DM were more likely to achieve glycaemic targets [18][19][20].…”

Section: Discussioncontrasting

confidence: 56%

The Characteristics of Patients whose both Fasting and Postprandial Glucose were Controlled by Once Daily Basal Insulin Monotherapy

Kim¹

2016

J Diabetes Metab

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Background: Several meta-analyses compared insulin monotherapy and combined therapy of insulin and oral hypoglycemic agents (OHA). However, these were not consistent and not focused to individualization. Therefore, we try to elucidate the characteristics of patients whose both fasting and postprandial glucose were controlled by once daily basal insulin monotherapy. Methods:The data of this study are part of our previous study which investigated characteristics of responders on different medications for controlling postprandial glucose levels after optimizing fasting glucose levels by insulin glargine. Background OHA cessation for 2 weeks of initial washout period and then insulin glargine was initiated. Oral glucose tolerance tests after initial wash out period and 7 point self-monitoring blood glucose test for 3 days at each step was completed by each subject. Results:The patients in Controlled group were younger, had a lower baseline A1c, and lower OGTT 2hr PPG levels than patients in the Non-Controlled group. Controlled group showed higher homeostasis model analysis % β (HOMA %B), corrected insulin response (CIR) and insulin-to-glucose ratio (IGR) than Non-Controlled group. Homeostasis model analysis insulin resistance (HOMA IR), 1/fasting insulin (by FI) and insulin sensitivity index (ISI) were similar between the two groups.Conclusions: In our study, some patients can be well controlled both fasting and postprandial glucose level with once daily insulin glargine monotherapy. Patients able to do so were younger, had lower baseline HbA1c, lower oral glucose tolerance test (OGTT) 2h PPG and higher makers of insulin secretion.

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“…Moreover, in the ORIGIN study, early insulin therapy targeting HbA 1c < 6.5% reduced the risk of people with IGT progressing to T2DM, with a low risk of hypoglycaemia, only moderate weight gain and doses of insulin glargine consistent with those typically required during phase-III studies of T2DM. There is now a mass of evidence from clinical trials and long-term outcome studies that early introduction of basal insulin is effective at keeping glucose levels within the target range with doses < 0.4 U/kg, which are associated with a low risk of severe hypoglycaemia and only moderate, if any, weight gain [8,31,39]. In contrast, late basal insulin introduction requires a high dose of insulin glargine with excessive weight gain observed as an adverse effect [60].…”

Section: Resultsmentioning

confidence: 99%

“…The EARLY study investigated the use of basal insulin as second-line therapy following failure of metformin in 1438 people with T2DM [38,39], and demonstrated that early basal insulin therapy was safe and effective, with HbA 1c levels decreasing from 8.69% to 7.39% and a low rate of hypoglycaemia over 24 weeks. Subgroup analyses found that people with lower HbA 1c levels at baseline, lower body mass index (BMI) and/or shorter duration of T2DM were more likely to achieve glycaemic targets (HbA 1c < 7%) [39].…”

Section: Studies Investigating Early Insulin For Non-cardiovascular Bmentioning

confidence: 99%

“…Subgroup analyses found that people with lower HbA 1c levels at baseline, lower body mass index (BMI) and/or shorter duration of T2DM were more likely to achieve glycaemic targets (HbA 1c < 7%) [39]. The GLORY study investigated the use of either metformin or insulin glargine as first-line treatment in 75 people with drug-naïve T2DM over 36 weeks [40].…”

Section: Studies Investigating Early Insulin For Non-cardiovascular Bmentioning

confidence: 99%

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Use of insulin in type 2 diabetes: What we learned from recent clinical trials on the benefits of early insulin initiation

Hanefeld

2014

Diabetes & Metabolism

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The majority of people with type 2 diabetes mellitus (T2DM) require insulin therapy to maintain HbA(1c) levels < 7% during the first decade of diagnosis. Large prospective trials investigating the cardiovascular (CV) benefits of intensive glycaemic control have produced inconsistent results; however, meta-analyses have suggested that intensive glycaemic control provides both micro- and macrovascular benefits. The ORIGIN study investigated the impact of basal insulin glargine therapy targeting ≤ 5.3 mmol/L for fasting plasma glucose compared with standard care on CV outcomes in people with pre- or early diabetes, and demonstrated a neutral effect on CV outcomes with long-term use of insulin glargine early in the course of diabetes, with a low rate of severe hypoglycaemia and modest weight gain. The EARLY, GLORY and EASIE studies also demonstrated that insulin use earlier in the treatment pathway led to improved glycaemic control, reduced weight gain and fewer hypoglycaemic episodes than when insulin was added later in the course of disease. The beneficial effect of early transient intensive insulin therapy (TIIT) at diagnosis has been demonstrated in a number of trials; it rapidly limits the damage caused by gluco- and lipotoxicity, improving residual β-cell function and potentially slowing disease progression. The evidence suggests that people newly diagnosed with T2DM and HbA(1c) > 9% should be given early TIIT to achieve normoglycaemia within weeks, after which standard care should then be adopted. Insulin use earlier in the treatment pathway should be considered, as it reduces the risk of hypoglycaemia as well as allows β-cell rest, which can help preserve β-cell function.

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Predictors of Response to Early Basal Insulin Treatment in Patients with Type 2 Diabetes—The EARLY Experience

Abstract: Identified predictors of greater HbA1c reduction, target goal achievement, and insulin dose needed may help to optimize the balance of benefits and risks with the use of insulin glargine.

Cited by 19 publications

References 17 publications

Predictors of treatment response in type‐2 diabetes patients initiating basal‐supported oral therapy with insulin glargine 100 U/mL: A sub‐analysis of the Titration and OPtimisation (TOP) registry

Predictors of treatment response in type‐2 diabetes patients initiating basal‐supported oral therapy with insulin glargine 100 U/mL: A sub‐analysis of the Titration and OPtimisation (TOP) registry

The Characteristics of Patients whose both Fasting and Postprandial Glucose were Controlled by Once Daily Basal Insulin Monotherapy

Use of insulin in type 2 diabetes: What we learned from recent clinical trials on the benefits of early insulin initiation

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