Dataset Information

Efficacy of iGlarLixi in adults with type 2 diabetes inadequately controlled (glycated haemoglobin ≥8%, ≥64 mmol/mol) on two oral antidiabetes drugs: Post hoc analysis of the LixiLan-O randomized trial.

ABSTRACT:

Aims

To assess the efficacy and safety of iGlarLixi (the titratable fixed-ratio combination of insulin glargine 100 U/mL [iGlar] plus lixisenatide [Lixi]), in adults with type 2 diabetes (T2D) with glycated haemoglobin (HbA1c) levels ≥8% (≥64 mmol/mol).

Materials and methods

The LixiLan-O study (NCT02058147) compared iGlarLixi with iGlar or Lixi in adults with T2D inadequately controlled on metformin ± a second oral antidiabetes drug (OAD). This exploratory analysis evaluated the LixiLan-O subgroup of participants with baseline HbA1c levels of ≥8% (≥64 mmol/mol) who were receiving metformin plus a second OAD at screening.

Results

The mean diabetes duration was 10.0 years, and the mean duration of second OAD use was 4.5 years. iGlarLixi demonstrated greater mean reductions from baseline in HbA1c and 2-hour postprandial glucose (PPG) compared with iGlar or Lixi (HbA1c -1.9% vs. -1.6% or -1.0% [-20 vs. -17 or -10 mmol/mol; 2-hour PPG -7.2 vs. -4.6 or -5.5 mmol/L). Greater proportions of participants achieved HbA1c <7% (<53 mmol/mol) with iGlarLixi versus iGlar or Lixi (67% vs. 51% or 18%), and the composite endpoints of HbA1c <7% (<53 mmol/mol) with no body weight gain (36% vs. 19% or 16%), and HbA1c <7% (<53 mmol/mol) with no body weight gain and no documented symptomatic hypoglycaemia (plasma glucose ≤3.9 mmol/L; 28% vs. 15% or 15%). The incidence rates of documented symptomatic hypoglycaemia were 29.0%, 27.9% and 12.1% for iGlarLixi, iGlar and Lixi, respectively.

Conclusions

Adults with T2D and HbA1c ≥64 mmol/mol (≥8%) despite two OADs at screening achieved better glycaemic control with iGlarLixi versus iGlar or Lixi, without increased risk of hypoglycaemia versus iGlar.

SUBMITTER: Davies MJ

PROVIDER: S-EPMC9293415 | biostudies-literature | 2022 Jan

REPOSITORIES: biostudies-literature

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Publications

Efficacy of iGlarLixi in adults with type 2 diabetes inadequately controlled (glycated haemoglobin ≥8%, ≥64 mmol/mol) on two oral antidiabetes drugs: Post hoc analysis of the LixiLan-O randomized trial.

Davies Melanie J MJ Rosenstock Julio J Ali Amar A Russell-Jones David D Souhami Elisabeth E Palmer Karen K Ji Chen C Niemoeller Elisabeth E Skolnik Neil N

Diabetes, obesity & metabolism 20211006 1

<h4>Aims</h4>To assess the efficacy and safety of iGlarLixi (the titratable fixed-ratio combination of insulin glargine 100 U/mL [iGlar] plus lixisenatide [Lixi]), in adults with type 2 diabetes (T2D) with glycated haemoglobin (HbA1c) levels ≥8% (≥64 mmol/mol).<h4>Materials and methods</h4>The LixiLan-O study (NCT02058147) compared iGlarLixi with iGlar or Lixi in adults with T2D inadequately controlled on metformin ± a second oral antidiabetes drug (OAD). This exploratory analysis evaluated the ...[more]

PMID: 34617398

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Project description:INTRODUCTION:The treatment of patients with type 2 diabetes uncontrolled on basal insulin and oral glucose-lowering drugs was investigated previously in the LixiLan-L trial. In the LixiLan-L trial, patients experienced a 6-week run-in with insulin glargine U100 (iGlar) as part of the screening phase, followed by treatment with a fixed-ratio combination of iGlar + lixisenatide (iGlarLixi) or iGlar alone over 30 weeks. In the study reported here, we investigated the achievement of glycemic control in those who completed the 30-week LixiLan-L trial, as assessed by change in glycated hemoglobin (HbA1c) levels from screening, both for the overall category and for screening HbA1c subcategories. METHODS:This post hoc analysis of the LixiLan-L trial included both the screening phase and the treatment period for 30-week completers and evaluated the change in HbA1c from screening to Week 30, patients reaching HbA1c < 7% at Week 30, and iGlar and lixisenatide (Lixi) doses at Week 30 overall and according to HbA1c subcategory at screening (HbA1c ≤ 8%, 8% < HbA1c ≤ 9%, and HbA1c > 9%). Documented symptomatic hypoglycemia during the treatment period was also assessed. RESULTS:HbA1c reductions (least squares mean) from screening to Week 30 were greater for iGlarLixi than iGlar, both overall (- 1.7 vs. - 1.1%) and in all subgroups (HbA1c ≤ 8%, 8% < HbA1c ≤ 9%, and HbA1c > 9%): - 1.1, - 1.4, - 2.4 (iGlarLixi) vs. - 0.5, - 1.0, - 1.8% (iGlar), respectively (all p < 0.0001). The end-of-treatment mean HbA1c level for iGlarLixi across all groups was < 7%. More patients achieved an HbA1c of < 7% with iGlarLixi than with iGlar, both overall (59.9 vs. 31.2%) and within each subgroup [74.2, 54.7, 52.2 (iGlarLixi) vs. 37.2, 31.6, 23.5% (iGlar), respectively]. A higher initial screening HbA1c corresponded with a greater mean reduction in HbA1c for both treatment strategies. In all HbA1c screening categories, the risk of hypoglycemia was not increased with iGlarLixi versus iGlar during the treatment phase. CONCLUSION:iGlarLixi controlled HbA1c levels more effectively than iGlar across all HbA1c screening subgroups and in the overall study population without increasing the risk of hypoglycemia. TRIAL REGISTRATION:Clinicaltrials.gov Identifier: NCT02058160. FUNDING:Sanofi.

Project description:ObjectivesTo determine whether the impact of guided self-determination (GSD) applied in group training (GSD-GT) in people with chronically elevated HbA1c and type 1 diabetes mellitus (DM) was superior to 'care as usual' in improving HbA1c and psychological functioning.SettingAn outpatient clinic at a university hospital in Western Norway.ParticipantsA total of 178 adults (all Caucasian) aged 18-55 (mean age 36.7±10.7, 62% women) with type 1 DM for at least 1 year and HbA1c ≥64 mmol/mol (8.0%) were randomly assigned to participate in either GSD-GT or a control group (CG). Exclusion criteria were severe comorbidity, major psychiatric disorder, cognitive deficiency/language barriers and pregnancy.InterventionIntervention group met seven times for 2 hours over 14 weeks to promote patient autonomy and intrinsic motivation using reflection sheets and advanced professional communication in accordance with the GSD methodology.Primary and secondary outcome measuresThe primary outcome was HbA1c and secondary outcomes (all outcomes 9 months post intervention) were self-monitored blood glucose frequency, self-reported diabetes competence, autonomy support by healthcare providers (Health Care Climate Questionnaire), autonomous versus controlled diabetes motivation (Treatment Self-Regulation Questionnaire), diabetes distress (Problem Areas In Diabetes Scale (PAID) and Diabetes Distress Scale (DDS)), self-esteem (Rosenberg Self-Esteem Scale) and psychological well-being (World Health Organization five-item Well-Being Index scale).ResultsAmong participants allocated to the GSD-GT (=90) 48 completed the study, whereas 83 completed in the CG (n=88). With 95% CIs GSD-GT did not have effect on HbA1c (B -0.18, CI (-0.48, 0.12), p=0.234). GSD-GT improved autonomy-motivated behaviour (B 0.51, CI (0.25, 0.77), p<0.001), diabetes distress (PAID, B -6.96, CI (-11.40, -2.52), p=0.002), total DDS (B -5.15, CI (-9.34, -0.96), p=0.016), DDS emotional burden (B -7.19, CI (-13.20, -1.19), p=0.019) and self-esteem (B 1.43, CI (0.34, 2.52), p=0.011).ConclusionsResults from this behavioural intervention must be interpreted cautiously because of recruitment and attrition problems. Medical outcomes did not improve. Psychological outcomes improved, especially reduced diabetes distress.Trial registration numberClinical Trials.gov NCT 01317459.

Dataset Information

Efficacy of iGlarLixi in adults with type 2 diabetes inadequately controlled (glycated haemoglobin ≥8%, ≥64 mmol/mol) on two oral antidiabetes drugs: Post hoc analysis of the LixiLan-O randomized trial.

Aims

Materials and methods

Results

Conclusions

Publications

Efficacy of iGlarLixi in adults with type 2 diabetes inadequately controlled (glycated haemoglobin ≥8%, ≥64 mmol/mol) on two oral antidiabetes drugs: Post hoc analysis of the LixiLan-O randomized trial.

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