Thomas Danne, Germany

Moderator of 1 Session

PARALLEL SESSION Webcast
Session Type
PARALLEL SESSION
Channel
Auditorium A
Date
20.02.2020, Thursday
Session Time
13:00 - 14:30

Presenter of 4 Presentations

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

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).

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Conclusions

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

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Debate on SGLT2 for T1D: Pro

Session Type
PARALLEL SESSION
Date
20.02.2020, Thursday
Session Time
16:40 - 18:00
Channel
Rome
Lecture Time
16:40 - 16:55

Abstract

Background and Aims / Part 1

Patients with type 1 diabetes are facing the sobering outlook that today despite improvements in insulin therapy they are prone to increased cardiovascular mortality. The onset of type 1 diabetes before age 10 has been associated with 17 years loss of life in girls and 14 years in boys. In addition, increasing incidence of overweight, hypertension and negative psychosocial consequences due to unpredictable glucose swings are other unmet needs that potentially can be addressed by adjunct therapy with SGLT inhibitors.

Methods / Part 2

Dapagliflozin and sotagliflozin have been approved for adjunct therapy in certain patients with type 1 diabetes in Europe. In Germany, the Federal Joint Committee (G-BA), the highest decision-making body of the joint self-government of physicians, hospitals and health insurance funds, has recently issued a positive benefit assessment for dapagliflozin. Also, in the UK, the cost-effectiveness estimate for dapagliflozin plus insulin compared with insulin alone was judged to be within the range that NICE normally considers an acceptable use of NHS resources. Certainly this therapy is not suited for every patient with type 1 diabetes.

Results / Part 3

Current prerequisites for adjunct therapy with SLT inhibitors include a body mass index (BMI) of at least 27 kg/m2, when insulin alone does not provide adequate glycemic control despite optimal insulin therapy, and if patients have completed a structured education program about diabetic ketoacidosis. Treatment should be started and supervised by a consultant physician specializing in diabetes. Evidence from the clinical trials show small improvements in HbA1c levels and increases of up to 3 hours time in range by CGM as well as an average weight loss of 3kg in overweight individuals, and improvements in quality of life, when SGLT inhibitors plus insulin are compared with placebo plus insulin in adults with type 1 diabetes.

Conclusions / Part 4

Thus, adjunct therapy should be initiated in adults with type 1 diabetes if an individual risk / benefit assessment as outlined above indicates the likelihood of positive outcomes.

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Experience with risk mitigation using SGLT inhibitors in type 1 diabetes

Session Type
PARALLEL SESSION
Date
21.02.2020, Friday
Session Time
09:00 - 10:00
Channel
Auditorium A
Lecture Time
09:40 - 10:00

Abstract

Background and Aims / Part 1

Experiences with adjunct therapy with SGLTinhibitors in type 1 diabetes, both, during the regulatory trials as well as through off-label use have contributed to recent international DKA risk mitigation consensus.

Methods / Part 2

These recommendations have been the basis for a package of mandatory patient and provider information, which has been developed by the pharmaceutical company ((https://www.frx-schulungsmaterial.de. Recently a structured, product independent education program “KetoAWARE” for DKA risk mitigation was developed by FIDAM (https://www.fidam.de/ketoaware) together with international experts. It can be downloaded and used for individual or group-based educational sessions for adult users of SGLT inhibitors. It is currently available in German and English and ten more languages are coming soon. In addition, a Smartphone App will be developed by the end of the year. This App aims at improving ongoing support for SGLT users regarding DKA management in daily life.

Results / Part 3

Real-world data from the German DPV-Registry show that the approval of SGLTinhibitors for certain patients with type 1 diabetes are likely to lead to considerable use.

Conclusions / Part 4

Such real-world data will be helpful to monitor the development of acute complications like hypoglycemia and DKA during adjunct therapy with SGLT in patients with type 1 diabetes.

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INSULIN GLARGINE 300 U/ML (GLA-300) PROVIDES EFFECTIVE GLYCAEMIC CONTROL IN YOUTHS WITH TYPE 1 DIABETES (T1D): THE EDITION JUNIOR STUDY