E-POSTER VIEWING (EXHIBITION HOURS)
Session Type
E-POSTER VIEWING (EXHIBITION HOURS)
Channel
E-Poster Area
Date
20.02.2020, Thursday
Session Time
09:30 - 15:30
Session Description
PLEASE NOTE: E-POSTER VIEWING IS DURING THE EXHIBITION HOURS OF EACH DAY.

DIFFERENCES BETWEEN INSULIN GLARGINE 300 U/ML (GLA-300) AND INSULIN DEGLUDEC 100 U/ML (IDEG) IN HIGH-RISK TYPE 2 DIABETES (T2DM) POPULATIONS: SUBANALYSIS OF THE BRIGHT TRIAL

Session Name
NEW INSULIN ANALOGUES
Session Type
E-POSTER VIEWING (EXHIBITION HOURS)
Date
20.02.2020, Thursday
Session Time
09:30 - 15:30
Channel
E-Poster Area
Lecture Time
09:30 - 09:31
Presenter
  • Zsolt Bosnyak, France
Authors
  • Alice Cheng, Canada
  • Martin Haluzík, Czech Republic
  • Vanita R. Aroda, United States of America
  • Ronan Roussel, France
  • Naim Shehadeh, Israel
  • Zsolt Bosnyak, France
  • Felipe Lauand, France
  • Lydie Melas-melt, France
  • Julio Rosenstock, United States of America
  • Geremia B. Bolli, Italy

Abstract

Background and Aims

In BRIGHT (NCT02738151), Gla-300 showed similar glycaemic improvements to IDeg over 24 weeks in insulin-naïve participants with T2DM, with 24h hypoglycaemia incidence and rates being comparable between treatments during the maintenance and full-study periods, but lower with Gla-300 during the titration period. Older age and impaired renal function can increase hypoglycaemia risk; we evaluated the impact of baseline age and renal function on glycaemic and hypoglycaemia outcomes in BRIGHT.

Methods

BRIGHT was an open-label, actively-controlled, parallel-group trial in people with T2DM randomised to Gla-300 (N=466) or IDeg (N=463). This post-hoc analysis evaluated HbA1c change and incidence and rates of 24h confirmed (≤3.9mmol/L [≤70mg/dL]) hypoglycaemia over 24 weeks, by age and renal function subgroups.

Results

HbA1c reduction was greater with Gla-300 versus IDeg in participants ≥70 years, with significant heterogeneity of treatment effect between ≥70 and <70 years subgroups (p=0.0087). Hypoglycaemia incidence and rates were similar between treatments in both groups. Significant heterogeneity of treatment effect across renal function groups for HbA1c reduction (p=0.015) reflected greater HbA1c reduction with Gla-300 versus IDeg in patients with impaired renal function (eGFR <60 mL/min/1.73m2). Hypoglycaemia incidence was similar with Gla-300 and IDeg across all eGFR subgroups. Hypoglycaemia rates were similar between treatments in participants with eGFR <60 mL/min/1.73m2, though lower with Gla-300 versus IDeg in those with normal renal function (eGFR ≥90 mL/min/1.73m2).

Conclusions

In people with T2DM at high risk of hypoglycaemia (≥70 years, impaired renal function), Gla-300 provided greater reductions in HbA1c versus IDeg, without increased incidence or rates of hypoglycaemia.

Study sponsored by Sanofi

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LOWER RISK FOR SEVERE HYPOGLYCEMIA WITH GLA-300 VS. GLA-100 IN PATIENTS WITH TYPE 1 DIABETES (T1D): A META-ANALYSIS OF 6-MONTH PHASE 3 CLINICAL TRIALS

Session Name
NEW INSULIN ANALOGUES
Session Type
E-POSTER VIEWING (EXHIBITION HOURS)
Date
20.02.2020, Thursday
Session Time
09:30 - 15:30
Channel
E-Poster Area
Lecture Time
09:31 - 09:32
Presenter
  • Thomas Danne, Germany
Authors
  • Thomas Danne, Germany
  • Munehide Matsuhisa, Japan
  • Christian Sussebach, Germany
  • Harmonie Goyeau, France
  • Felipe Lauand, France
  • Elisabeth Niemöller, Germany
  • Geremia B. Bolli, Italy

Abstract

Background and Aims

In this post hoc meta-analysis 6-month data sets from three randomised controlled open-label phase 3 trials with insulin glargine 300 U/ml (Gla-300) versus insulin glargine 100 U/ml (Gla-100) in patients with T1D were pooled for analysis of severe hypoglycaemia.

Methods

All trials were similarly designed and achieved their primary endpoint of HbA1c non-inferiority of Gla-300 versus Gla-100. EDITION 4 (n=549) and JUNIOR (n=463) were conducted worldwide and EDITION JP1 (n=243) was conducted in Japan. EDITION 4 and EDITION JP1 studied adults aged ≥18 years; JUNIOR enrolled participants aged 6–17 years. In total, 629 participants received Gla-300 and 624 received Gla-100 together with prandial insulin. Severe hypoglycemia was defined in adults as a hypoglycaemic event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions, and in children and adolescents as having altered mental status and inability to assist in their care, being semiconscious or unconscious, or in coma ± convulsions requiring possible parenteral therapy (glucagon and/or glucose).

Results

During the 6-month treatment period fewer patients experienced severe hypoglycaemic events with Gla-300 (n=39, 6.2%) versus Gla-100 (n=58, 9.3%); Odds Ratio 0.65 (95% CI 0.42–0.98). The Kaplan–Meier plot (Stratified Log-rank-Test: p=0.038) demonstrated persistence of risk reduction over time (Figure). Similarly, the event rate for severe hypoglycaemia was numerically lower with Gla-300 versus Gla-100 (0.23 vs 0.29 events/patient-year; Relative Risk 0.80, 95% CI 0.49–1.29).

figure.png

Conclusions

Gla-300 showed a lower risk for severe hypoglycemia compared to Gla-100 in people with T1D.

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INRANGE: A RANDOMIZED CONTROLLED TRIAL COMPARING GLA-300 VS IDEG-100 IN PEOPLE WITH TYPE 1 DIABETES (T1D) USING CONTINUOUS GLUCOSE MONITORING (CGM)

Session Name
NEW INSULIN ANALOGUES
Session Type
E-POSTER VIEWING (EXHIBITION HOURS)
Date
20.02.2020, Thursday
Session Time
09:30 - 15:30
Channel
E-Poster Area
Lecture Time
09:32 - 09:33
Presenter
  • Zsolt Bosnyak, France
Authors
  • Steven Edelman, United States of America
  • Zsolt Bosnyak, France
  • Timothy Bailey, United States of America
  • Richard M. Bergenstal, United States of America
  • Alice Cheng, Canada
  • Tadej Battelino, Slovenia

Abstract

Background and Aims

Insulin glargine 300 U/mL (Gla-300) and insulin degludec 100 U/mL (IDeg-100) have shown slightly different pharmacokinetic/pharmacodynamic profiles; however, the first head-to-head randomised controlled trial in insulin-naïve people with type 2 diabetes (T2D) demonstrated similarity in clinical endpoints, except during the 0–12 week period when results were in favour of Gla-300 for anytime hypoglycaemia.

InRange aims to assess the clinical impact of Gla-300 and IDeg-100 in people with T1D by assessing primarily continuous glucose monitoring (CGM) endpoints.

Methods

Approximately 340 people with T1D aged 18–70 years, on a basal + mealtime insulin regimen for ≥1 year, and HbA1c ≥7 % and <10 % will be included. Screening (1–2 weeks) will be followed by a 4-week run-in (background insulin treatment optimisation including 2-weeks baseline CGM) and a 12-week randomised treatment period after basal insulin switch to Gla-300 or IDeg-100 (titrated to the target glucose range without hypoglycaemia). During the randomised period, CGM will be performed at weeks 11–12 according to the most recent CGM consensus statement and ADA guidelines. The primary endpoint will be analysed using a mixed-effect model with repeated measures approach.

Results

Study ongoing

Conclusions

The objectives are to assess the percentage time in range for glucose (70–180 mg/dL [3.9–10 mmol/L]) (primary endpoint) at week 12, and glucose variability (reported as coefficient of variation [total, within day, between day]); in addition to other clinical outcomes including occurrence and frequency of hypoglycaemia (severe; documented symptomatic; and asymptomatic (<70 mg/dL [<3.9 mmol/L], <54 mg/dL [<3.0 mmol/L])).

Supported by:Sanofi, EudraCT: 2017-002756-91; NCT04075513

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SWITCHING FROM NPH INSULIN TO GLARGNIE U300 RESULTS IN SIGNIFICANT DECREASE OF HBA1C AND REDUCTION OF HYPOGLYCEMIA RISK – RESULTS OF MULTICENTER, PROSPECTIVE OBSERVATIONAL STUDY

Session Name
NEW INSULIN ANALOGUES
Session Type
E-POSTER VIEWING (EXHIBITION HOURS)
Date
20.02.2020, Thursday
Session Time
09:30 - 15:30
Channel
E-Poster Area
Lecture Time
09:33 - 09:34
Presenter
  • Tomasz Klupa, Poland
Authors
  • Bogumil Wolnik, Poland
  • Dorota Wiza, Poland
  • Tomasz Szczepanik, Poland
  • Albert Syta, Poland
  • Tomasz Klupa, Poland

Abstract

Background and Aims

The aim of this study was to evaluate the efficacy and safety of glargine U300 in patients with type 2 diabetes (DM2) recently switched from NPH insulin in real-life settings

Methods

We conducted a national, observational, multicenter, prospective, 24-weeks product registry. The primary endpoint was percentage of patients reaching HbA1c reduction of 0.5% or more at the end of the study (EOS); the secondary endpoints were: FPG and HbA1c level at EOS and change from baseline, number of of participants, who experienced ≥1 episode of symptomatic nocturnal hypoglycemia.

Results

Among 469 analyzed patients, the primary endpoint was achieved by 71.7% of patients. HbA1c decreased by 1.02 ± 1.11 % (p<0.0000 vs. baseline) from 9.19 ± 1.11 % at baseline to 8.17 ± 1.17 % at EOS. Average FPG decreased by 37.1 ± 44.5 mg/dL (p<0.0000 vs. baseline) from 178.0 ± 46.0 mg/dL to 140.9 ± 40.7 mg/dL at EOS. The number of participants, who experienced ≥1 episode of symptomatic nocturnal hypoglycemia decreased significantly from 76 (66.1%) at baseline to 9 (14.8%) after 24 weeks of observation (p<0.0000). Average annual rate of symptomatic nocturnal hypoglycemia episodes was 0.33. None of the patients had severe hypoglycemia after switching to glargine U300 throughout whole observation period. The body weight did not change significantly.

Conclusions

It has been shown that people with uncontrolled T2D treated with NPH that switching to Gla-300 significantly improved their glycemic control while significantly decreasing the number of both symptomatic and nocturnal hypoglycemia events

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THE FORGOTTEN POPULATIONS: REAL-WORLD PATIENTS WITH T2DM NOT MEETING ELIGIBILITY CRITERIA OF THE GLARGINE 300 U/ML EDITION AND BRIGHT RCTS

Session Name
NEW INSULIN ANALOGUES
Session Type
E-POSTER VIEWING (EXHIBITION HOURS)
Date
20.02.2020, Thursday
Session Time
09:30 - 15:30
Channel
E-Poster Area
Lecture Time
09:34 - 09:35
Presenter
  • Jukka Westerbacka, France
Authors
  • Didac Mauricio, Spain
  • Jukka Westerbacka, France
  • Charlie Nicholls, United Kingdom
  • Jasmanda Wu, United States of America
  • Rishab Gupta, United States of America
  • Arjun A. Menon, United States of America
  • Björn Eliasson, Sweden

Abstract

Background and Aims

Randomised controlled trials (RCTs) are the gold standard for comparing therapies’ efficacy and safety but can have strict eligibility criteria and may not reflect real-life clinical practice. Electronic medical records such as those from the Predictive Health Intelligence Environment (PHIE) database may be used to assess clinical effectiveness in real-world populations missed by clinical trials. We describe here the proportion and characteristics of patients with type 2 diabetes mellitus (T2DM) who would have been excluded from RCTs using eligibility criteria adapted from the EDITION 1–3 and BRIGHT trials.

Methods

Records from people with T2DM, with a basal insulin prescription on the index date (01 March 2015) and ≥1 HbA1c value in the previous 12 months, were evaluated. Exclusion criteria included HbA1c <7.0 % / >10.0 %, systolic blood pressure >180 mmHg and/or diastolic blood pressure >95 mmHg, or key comorbidities (e.g. heart failure or stroke) in the previous 12 months.

Results

Of 191,218 evaluated records, 157,873 (83%) met ≥1 exclusion criterion; only 33,345 (17%) could have been included in RCTs (Table). Excluded patients were older, with more previous hypoglycaemia vs included patients, and were less likely to have HbA1c between 7 and 9 %.

table.png

Conclusions

This divergence in clinical characteristics and patient numbers highlights the need for real-world studies assessing clinical effectiveness in populations of interest typically excluded from RCTs.

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EVALUATION OF C-REACTIVE PROTEIN ALTERATION IN OBESE WOMEN

Session Name
NEW INSULIN ANALOGUES
Session Type
E-POSTER VIEWING (EXHIBITION HOURS)
Date
20.02.2020, Thursday
Session Time
09:30 - 15:30
Channel
E-Poster Area
Lecture Time
09:35 - 09:36
Presenter
  • Nwakonobi C. Moses, Nigeria
Authors
  • Chiedozie E. Jumbo, Nigeria
  • Nwakonobi C. Moses, Nigeria

Abstract

Background and Aims

Obessity is a medical condition in which excess body fat has accumulated to the extent that it may have an adverse effect on health leading to reduced life expentancy(WHO,2000).It is a chronic disorder prevalent in both developed and developing countries.It is one of the most significant contributors to morbid conditions like metabolic syndrom, type-2 diabetes melitus and cardiovascluar disorder(CVD) (Weisbierg et al 2003). People are considered obese when thier body mass index (BMI) exceeds 30kg/m2. Obesity increases the likelyhood of various diseases particularly heart disease. This study was carried out to determine alteration of C-reactive protein in the obesse women and non-obesse women attending treatment at the Federal Medical Center Owerri,South-East,Nigeria.

Methods

This study was carried out to determine alteration of C- reactive protein in the obese women and non –obese women attending treatment at the Federal Medical Center Owerri, South East Nigeria involving a total of 40 subject, which were divided into two groups; 20 obese women and 20 non-obese women, C -reactive protein concentration was measured by latex agglutination method. In the study, the C- reactive was compared between the obese and non- obese women.

Results

The result obtained showed that C –reactive protein concentration was significantly increased in obese women (3.55+0.778 mg /dl) when compared with non- obese women (0.41+0.083 mg/dl), at P<0.05. This finding indicates that C- reactive protein level increases in obesity hence, could serve as biochemical marker in obesity.

Conclusions

This study concludes that C-reactive protein level increases in obesity thus,could serve as biochemical marker in obesity

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ANTI-INSULIN ANTIBODY CONCENTRATION IN TYPE 1 DIABETES MELLITUS PATIENTS INJECTING DIFFERENT TYPES OF INSULIN

Session Name
NEW INSULIN ANALOGUES
Session Type
E-POSTER VIEWING (EXHIBITION HOURS)
Date
20.02.2020, Thursday
Session Time
09:30 - 15:30
Channel
E-Poster Area
Lecture Time
09:36 - 09:37
Presenter
  • Anna Mosikian, Russian Federation
Authors
  • Anna Mosikian, Russian Federation
  • Igor Makarenko, Russian Federation
  • Tatiana Belikova, Russian Federation
  • Roman Drai, Russian Federation

Abstract

Background and Aims

Regulatory guidelines for insulin products (IPs) development require to test immunogenicity in a reasonable number of patients with type 1 diabetes mellitus (T1DM). The problem of sample size for immunogenicity comparison is substantial in insulin biosimilar development since the required samples are sizeable however still incapable to detect any immunogenicity difference, because the biosimilar and a reference drug are very similar in all terms. The aim of this study was to estimate the input of IP into immune response development.

Methods

Blood samples of 180 T1DM patients were taken to estimate an anti-insulin antibody concentration (AIAC) via enzyme-linked immunosorbent assay. The information on insulin international non-proprietory name (INN) was gathered. Influence of basal and bolus insulin INNs on AIAC was estimated with ANOVA. One-to-one comparisons were made with Mann-Whitney U-test.

Results

Patients were administered 4 INNs of basal insulin (glargine, detemir, degludec, isofan) and 4 INNs of bolus insulin (lispro, aspart, apidra, human soluble). AIAC did not depend on INN of insulin administered to a patient (p=0.765 for basal insulin, p=0.283 for bolus insulin). AIAC did not differ in patients receiving insulin analogues and human insulins (p=0.374 for basal insulin, p=0.751 for bolus insulin).

Conclusions

IP’s input into immune response development was nonsignificant, thus the huge sample is required to detect immunogenicity difference. This leads to dramatic increase of clinical trials cost and breaks the idea of cost-affordable biosimilars. Thus immunogenicity risk assessment should be provided mostly at preclinical stage, and immunogenicity should be studied via pharmacovigilance.

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INSULIN GLARGINE BIOSIMILAR (GP40061) SHOWS SIMILAR PHARMACOKINETICS AND PHARMACODYNAMICS AS COMPARED TO THE REFERENCE DRUG

Session Name
NEW INSULIN ANALOGUES
Session Type
E-POSTER VIEWING (EXHIBITION HOURS)
Date
20.02.2020, Thursday
Session Time
09:30 - 15:30
Channel
E-Poster Area
Lecture Time
09:37 - 09:38
Presenter
  • Anna Mosikian, Russian Federation
Authors
  • Anna Mosikian, Russian Federation
  • Igor Makarenko, Russian Federation
  • Olga Avdeeva, Russian Federation
  • Tatiana Belikova, Russian Federation
  • Ivan Lunev, Russian Federation
  • Roman Drai, Russian Federation

Abstract

Background and Aims

A biosimilar is a biological medicine highly similar to already approved biological reference medicine. The program of clinical trials of insulin biosimilars includes pharmacology studies: pharmacokinetics (PK) – concentration-time and pharmacodynamics (PD) – glucose infusion rate (GIR)-time. The aim of this study was to test if GP40061 – a biosimilar to reference insulin glargine (RIG) – has similar PK and PD profiles in a hyperinsulinemic euglycaemic clamp (HEC) setting in patients with type 1 diabetes mellitus (T1DM).

Methods

A double-blind, randomized, crossover study enrolled 42 adult patients with T1DM. The study was conducted in accordance with international guidelines for HEC studies. Each patient received a single dose of insulin (0.6 U/kg) subcutaneously. Regular blood sampling was performed. The amount of insulin glargine in the samples was determined by enzyme-linked immunosorbent assay. The primary endpoints were AUCins.0-24 (PK) and AUCGIR.0-24 (PD).We calculated the 90% (PK) and 95% (PD) confidence intervals (CI) of the GP40061/RIG geometric mean ratio for primary endpoints. Similarity of PK and PD is proved if CIs fall within the specified limits of 80%─125%. Secondary endpoints were AUCins.0-12 and AUCins.12-24 (PK), AUCGIR.0-12 and AUCGIR.12-24 (PD). Safety was also assessed.

Results

CIs were 81.02%─120.62% for AUCins.0-24 and 85.43%─115.64% for AUCGIR0-24. Ratio of AUCins.0-12 was 95.39%, AUCins.12-24 – 106.45%, AUCGIR.0-12 – 93.39% and AUCGIR.12-24 – 92.55%. Adverse events were registered in 11 patients in GP40061 and 9 patients on RIG (p=1.000).

Conclusions

GP40061 demonstrated similar PK and PD profiles to RIG. The study results proved biosimilarity of GP40061 to reference insulin glargine.

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INSULIN GLARGINE BIOSIMILAR (GP40061) SHOWS NO DIFFERENCE OF IMMUNOGENICITY AS COMPARED TO THE REFERENCE DRUG

Session Name
NEW INSULIN ANALOGUES
Session Type
E-POSTER VIEWING (EXHIBITION HOURS)
Date
20.02.2020, Thursday
Session Time
09:30 - 15:30
Channel
E-Poster Area
Lecture Time
09:38 - 09:39
Presenter
  • Anna Mosikian, Russian Federation
Authors
  • Anna Mosikian, Russian Federation
  • Igor Makarenko, Russian Federation
  • Olena Afonkina, Russian Federation
  • Bella Zinnatulina, Russian Federation
  • Roman Drai, Russian Federation

Abstract

Background and Aims

A biosimilar is a biological medicine highly similar to already approved reference biological medicine. GP40061 – is a biosimilar to reference insulin glargine (RIG). Its similarity to RIG has been proved through head to head analytical, preclinical and euglycemic clamp comparability studies. A comparative safety (immunogenicity) study of insulin biosimilar and reference drug is the last stage of the development program. This study aimed to confirm the similar immunogenicity of the drugs.

Methods

This randomized open-label, 26-week clinical trial (NCT02059187) enrolled 180 participants with type 1 diabetes mellitus randomized 1:1 to once-daily GP40061 (n=90) or RIG (n=90). The primary endpoint was frequency of immune response development at 26th week. Secondary endpoints included change of anti-insulin antibody (AIA) concentration at weeks 12 and 26 from baseline (at screening), percentage of participants with neutralizing AIA formation. AIA concentration was assessed via enzyme-linked immunosorbent assay. Neutralizing activity was established via binding of insulin alfa-chain and CD220 receptor. The data was compared with Mann-Whitney U-test or X2-test.

Results

Immune response was detected in 2 patients in GP40061 and in 2 patients in RIG (p=1.000). Change of AIA concentration (IU/ml) at week 12 from baseline was -0.19±2.49 (GP40061) and 1.38±10.98 (RIG) (p=0.399), and -0.02±2.85 (GP40061) and 0.30±4.07 at week 26 (p=0.167). Number of patients with neutralizing AIA formation was 17 (19%) in GP40061 and 15 (17%) in RIG (p=1.000).

Conclusions

GP40061 demonstrated similar immunogenicity to the RIG. Considering the whole development program, the biosimilarity of GP40061 to reference insulin glargine was proved.

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MISSED AND LATE MEAL BOLUSES WITH FASTER ACTING INSULIN ASPART (FIASP) VS INSULIN ASPART USING THE MEDTRONIC ADVANCED HYBRID CLOSED LOOP SYSTEM

Session Name
NEW INSULIN ANALOGUES
Session Type
E-POSTER VIEWING (EXHIBITION HOURS)
Date
20.02.2020, Thursday
Session Time
09:30 - 15:30
Channel
E-Poster Area
Lecture Time
09:39 - 09:40
Presenter
  • David N. O'neal, Australia
Authors
  • Melissa H. Lee, Australia
  • Sara Vogrin, Australia
  • Barbora Paldus, Australia
  • Jean Lu, Australia
  • Hannah Jones, Australia
  • Susan Wyatt, Australia
  • Emma Netzer, Australia
  • Dale Morrison, Australia
  • Catriona Sims, Australia
  • Alicia Jenkins, Australia
  • Balasubramanian Krishnamurthy, Australia
  • Richard Macisaac, Australia
  • Benyamin Grosman, United States of America
  • Anirban Roy, United States of America
  • Natalie Kurtz, United States of America
  • David N. O'neal, Australia

Abstract

Background and Aims

A missed or late meal insulin bolus can impact glycaemia in type 1 diabetes (T1D). The Medtronic Advanced Hybrid Closed Loop System (AHCL) delivering Faster Acting Insulin Aspart (FiAsp)[Novo-Nordisk] may provide better post-meal glycaemia with late and missed boluses compared with insulin aspart[Novo-Nordisk]. This study aimed to compare meal-time glycaemia in T1D participants with FiAsp and insulin aspart delivered by AHCL in the setting of missed and late meal boluses.

Methods

Twelve adult pump-experienced participants with T1D (median HbA1c 6.8% [IQR 6.2-7.2] | 51mmol/mol [44-55]) were commenced on AHCL, and assigned to FiASP or insulin aspart in random-order over two stages (6-weeks duration each). Participants ate a matched standardised 40g carbohydrate evening meal on two occasions (one without a bolus and one with a late bolus administered 20-min post-meal commencement) each during the FiAsp and insulin aspart stages of the study. CGM data 0-4 hours post-meal was analysed by signed rank test.

Results

To date, nine and eight participants respectively have completed the missed and late meal bolus challenges. While not statistically significant, there was a higher time in target range with FiAsp with missed bolus and a higher time in hypoglycaemia range with late bolus (Table). There were no major hypoglycaemia or hyperglycaemic excursions.

Conclusions

Trends observed with a missed meal bolus suggest that FiAsp may offer advantages over insulin aspart with regard to full CL function though late meal-time bolus delivery remains a risk for hypoglycaemia.

fiasp figure.jpg

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POSTPRANDIAL GLYCEMIC CONTROL WITH FAST-ACTING INSULIN ASPART IN PATIENTS WITH TYPE 1 DIABETES USING SENSOR-AUGMENTED PUMP THERAPY.

Session Name
NEW INSULIN ANALOGUES
Session Type
E-POSTER VIEWING (EXHIBITION HOURS)
Date
20.02.2020, Thursday
Session Time
09:30 - 15:30
Channel
E-Poster Area
Lecture Time
09:40 - 09:41
Presenter
  • Marcos Pazos-Couselo, Spain
Authors
  • Marcos Pazos-Couselo, Spain
  • Jose Manuel Garcia-lopez, Spain
  • Antia Fernandez-pombo, Spain
  • Maria Gonzalez-rodriguez, Spain

Abstract

Background and Aims

Fast‐acting insulin aspart (fAsp) is a faster‐acting insulin with a more rapid rate of absorption and greater early‐glucose‐lowering effect than conventional insulin (iAsp).

The aim of this study was to assess the postprandial glycemic control in patients with sensor-augmented pump therapy after one month of treatment with fAsp.

Methods

Five patients (2males) treated with sensor-augmented pump therapy (at least 6 months prior to the initiation of fAsp) whose age were 41±11 years and basal HbA1c 7,1±0,4%, were included.

Episodes of postprandial hyperglycemia (>140 mg/dL) were analysed before and after one-month treatment with fAsp. Other variables analysed were the area under the curve (AUC) >140 mg/dL, AUC <70 mg/dL, mean glucose and standard deviation (mg/dL), total insulin dose (IU/day) and basal/bolus distribution (%).

Results

Postprandial hyperglycemia episodes (>140 mg/dL) were reduced by 9.1% after one month of treatment with fAsp.

The continuous glucose monitoring results are shown in the following table:

iAsp

fAsp

Mean glucose (mg/dL)

151.8±22.3

151.6±11.1

Standard deviation (mg/dL)

53.6±9.0

49.4±7.2

Total insulin dose (IU/day)

41.8±19.2

41.7±16.4

Basal insulin (%)

44.8±9.0

44.8±6.3

Bolus insulin (%)

55.2±9.0

55.2±6.3

AUC >140 mg/dL

28.6±15.5

25.9±7.9

AUC <70 mg/dL

0.3±0.2

0.3±0.3

Conclusions

After one-month follow-up with fAsp, hyperglycemia events decreased without increasing the time in hypoglycemia and without changes in the basal/bolus distribution, in patients with sensor-augmented pump therapy.

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COMPARISON OF INSULIN DEGLUDEC AND GLARGINE U100 IN PATIENTS WITH TYPE 1 DIABETES PRONE TO SEVERE NOCTURNAL HYPOGLYCAEMIA

Session Name
NEW INSULIN ANALOGUES
Session Type
E-POSTER VIEWING (EXHIBITION HOURS)
Date
20.02.2020, Thursday
Session Time
09:30 - 15:30
Channel
E-Poster Area
Lecture Time
09:41 - 09:42
Presenter
  • Ulrik Pedersen-bjergaard, Denmark
Authors
  • Rikke M. Agesen, Denmark
  • Amra Alibegovic, Denmark
  • Henrik U. Andersen, Denmark
  • Henning Beck-nielsen, Denmark
  • Peter Gustenhoff, Denmark
  • Troels K. Hansen, Denmark
  • Christoffer Hedetoft, Denmark
  • Tonny Jensen, Denmark
  • Claus B. Juhl, Denmark
  • Andreas Kryger, Denmark
  • Susanne S. Lerche, Denmark
  • Kirsten Nørgaard, Denmark
  • Hans-Henrik Parving, Denmark
  • Anne L. Sørensen, Denmark
  • Lise Tarnow, Denmark
  • Birger Thorsteinsson, Denmark
  • Ulrik Pedersen-bjergaard, Denmark

Abstract

Background and Aims

Hypoglycaemia, especially nocturnal, remains the main limiting factor of achieving good glycaemic control in type 1 diabetes. This study aimed to investigate whether insulin degludec in comparison with insulin glargine U100 is superior in limiting the occurence of nocturnal hypoglycaemia in patients prone to nocturnal severe hypoglycaemia.

Methods

Danish investigator-initiated, prospective, randomised, open, blinded endpoint (PROBE), multicentre, cross-over study. Adult patients with type 1 diabetes and at least one episode of nocturnal severe hypoglycaemia during the preceding two years were included. A 1-year plus 1-year treatment period was specified, consisting of two 3-month run-in period, each followed by a 9-month maintenance period. The primary endpoint was number of nocturnal symptomatic hypoglycaemic episodes during the maintenance period, analysed by intention-to-treat.

Results

A total of 149 patients were randomised to insulin degludec or insulin glargine U100. When defining night-time from 00:00 to 05:59 treatment with insulin degludec resulted in a 28% (95%CI:5-45; p=0.02) and 37% (95%CI:16-53; p=0.002) relative risk reduction (RRR) of nocturnal symptomatic hypoglycaemia ≤3.9 mmol/L and ≤3.0 mmol/L, respectively, compared to insulin glargine U100. Similar results with insulin degludec was demonstrated when defining night-time from 23:00 to 06:59 with a 27% (95%CI: 8-43; p=0.01) and 34% (95%CI:18-48; p<0.001) RRR of nocturnal symptomatic hypoglycaemia ≤3.9 mmol/L and ≤3.0 mmol/L, respectively. No significant differences in glycaemic control between treatments.

Conclusions

Type 1 diabetes patients prone to nocturnal severe hypoglycaemia had lower rates of nocturnal hypoglycaemia with insulin degludec as compared to with insulin glargine U100. The difference was relatively greater with increased severity of nocturnal hypoglycaemia.

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COMPARISON OF EFFECTS WHEN SWITCHING LONG-ACTING INSULIN: RANDOMISED CROSSOVER STUDY

Session Name
NEW INSULIN ANALOGUES
Session Type
E-POSTER VIEWING (EXHIBITION HOURS)
Date
20.02.2020, Thursday
Session Time
09:30 - 15:30
Channel
E-Poster Area
Lecture Time
09:42 - 09:43
Presenter
  • SOICHI Takeishi, Japan
Authors
  • SOICHI Takeishi, Japan
  • Hiroki Tsuboi, Japan

Abstract

Background and Aims

We investigated glycaemic variability from one day before to 6 days after switching in patients treated with long-acting insulin.

Methods

This study was conducted during hospitalization. 20 type 2 diabetic patients on basal insulin therapy were randomly allocated to two groups. In Group1, fasting blood glucose level was stabilized (not exceeding 180 mg/dL) using insulin glargine 300 U/mL (Glargine300); Glargine300 was continued for 6 days with the same dose; a continuous glucose monitoring device (FreeStyle Libre Pro) was worn on the fifth day of Glargine300 administration of the same dose (=attaching day:Day1); next, Glargine300 was switched to insulin degludec (Degludec) on Day3 with the same dose, and then Degludec was continued for 6 days with the same dose; Degludec was then switched to Glargine300 on Day9 with the same dose, and then Glargine300 was continued for 6 days with the same dose. Long-acting insulin was injected at 08:00. Test meals were given. In Group2, patients were administered in the order of Degludec, Glargine300, and Degludec, following the same regimen as Group1. Evaluation duration was from 24-h before to 144-h after switching.

Results

Mean of daily difference (MODD) between day2 and day3 (switch day:day1) was significantly lower in patients who switched from Glargine300 to Degludec (pGtoD) than in patients who switched from Degludec to Glargine300 (pDtoG). The others endpoints weren’t significantly different between pGtoD and pDtoG (table).attd 2020 1 figure.jpg

Conclusions

Day-to-day glycaemic variability between day2 and day3 was lower in pGtoD than in pDtoG.

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