Condition category
Nutritional, Metabolic, Endocrine
Date applied
26/02/2019
Date assigned
27/02/2019
Last edited
27/02/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Background and study aims
All people with diabetes need insulin, either directly after diagnosis in patients with type 1 diabetes or at later disease stages in people with type 2 diabetes. There are two kind of insulin available to imitate the body’s missing insulin supply: basal insulin to cover the basal need for insulin and mealtime insulin to cover the shortly elevated need after meal intake. Advanced insulin therapies using one or two shots of mealtime insulin together with basal insulin are used in long-lasting type 2 diabetes and therapies with three shots of mealtime insulin are used in long-lasting type 2 diabetes as well as in type 1 diabetes. To take insulin goes hand in hand with hypoglycemia, an unwanted state of too low blood sugar with several symptoms, sometimes even including fainting and coma. Therefore, fear of hypoglycemia often prevents people with diabetes to achieve their blood sugar targets. On the other hand it is very important for patients with diabetes to reach their blood sugar targets to avoid late-stage complications like kidney disease, eye disorders and cardiovascular diseases. Several newer types of insulins have been developed, which reduce the risk for hypoglycemia compared to older types of insulin. The aim of this study is to find out, if switching from any other basal insulin to insulin glargine 300 units per milliliter, a newer basal insulin, allows more people with type 1 or type 2 diabetes on advanced insulin therapies (using a basal and a mealtime insulin) to reach their blood sugar targets without increasing the risk of hypoglycemia in daily clinical practice.

Who can participate?
Adults at or over the age of 18 years with type 1 or type 2 diabetes who use advanced insulin therapies (basal and mealtime insulin) and are treated by a German physician.

What does the study involve?
Participants are elected by their treating physician to join this study, if the physician had already decided to switch their basal insulin to insulin glargine 300 units per milliliter independent of the participation in this study. Participants will be treated by their physician as usual and will visit their doctor in the usual time intervals (in Germany usually every three months for diabetes patients). The physician will document several parameters at the first visit, when the basal insulin is switched, and at least 6 and 12 months thereafter. The study lasts one year in total. The participants are asked to answer a diabetes treatment satisfaction questionnaire at the first visit and at the visit 12 months thereafter.

What are the possible benefits and risks of participating?
There will be no immediate direct benefit or risk to those taking part, because this is a non-interventional study which means that patients are treated as they would be without participation in this study. However, the results of this study will add to the knowledge of how insulin glargine 300 units per milliliter is used in daily clinical practice and how its use in combination with mealtime insulins can be improved.

Where is the study run from?
The Toujeo-Neo study is being run by Sanofi-Aventis Deutschland GmbH and takes place in diabetologists’ and general practioners’, family physicians’ and internists’ practices all over Germany, where people with type 1 and type 2 diabetes are treated.

When is the study starting and now long is it expected to run for?
August 2015 to March 2017

Who is funding the study?
Sanofi-Aventis Deutschland GmbH (Germany)

Who is the main contact?
Dr. Stefan Pscherer, chief physician of Clinic of Internal Medicine III, Diabetology and Nephrology, Sophien- und Hufeland-Klinikum gGmbH, Henry-van-de-Velde-Str. 2, D-99425 Weimar, Germany, email: S.Pscherer@klinikum-weimar.de

Trial website

Contact information

Type

Scientific

Primary contact

Dr Katrin Pegelow

ORCID ID

Contact details

Sanofi-Aventis Deutschland GmbH
Potsdamer Str. 8
Berlin
D-10785
Germany
+49 (0)30 2575 2920
Katrin.Pegelow@sanofi.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

GLARGL07591

Study information

Scientific title

Assessment of Treatment Efficacy and Safety when switching the Basal component of any BOTplus or Basal-Bolus Regimen in Patients Failing to Reach Treatment Targets to Insulin glargine U300

Acronym

Toujeo-Neo

Study hypothesis

The aim of this non-interventional study (NIS) was to document the treatment effectiveness and safety after 6 and 12 months for diabetes patients who switched from a basal Insulin supported oral therapy with additional 1-2 prandial Insulin injections (BOTplus; type 2 diabetes mellitus) or a basal-bolus therapy (BBT; type 1 or type 2 diabetes mellitus; T1DM, T2DM) with any basal insulin other than insulin glargine 300 U/mL to a BOTplus or BBT with insulin glargine 300 U/mL under use in real-life conditions in daily clinical practice.

Ethics approval

Approved 27/07/2015, Ethik-Kommission der Bayerischen Landesärztekammer/Ethical committee of the state medical council of Bavaria (Mühlbaurstr.16, D-81677, Munich; + 49 89 4147-165; ethikkommission@blaek.de), ref: 15049

Study design

Non-interventional open-label multi-center single-arm prospective observational study

Primary study design

Observational

Secondary study design

Longitudinal study

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Type 1 and type 2 diabetes mellitus in adult patients requiring insulin therapy.

Intervention

All data were collected three times: at baseline, approximately 6 and approximately 12 months after starting insulin glargine 300 U/mL therapy. Baseline documentation (documentation 1) had to start immediately after switching to insulin glargine 300 U/mL from any other basal insulin after failing to achieve the glycemic targets on a pre-existing BOTplus (T2DM) or BBT (T1DM and T2DM) treatment. This had to occur after the physician had independently of the participation in this study decided to prescribe insulin glargine 300 U/mL and when thereafter the physician and the patient had decided the participation of the latter in this study. Next measurements were documented approximately 6 months thereafter (documentation 2) and the last measurements were documented approximately 12 months thereafter (documentation 3). Besides this, all FBG measurements available were collected on a monthly basis asking for documentation of changes during the last four weeks each month. Also, dosing information was captured every month; i.e. actual dose and frequency of dose changes during the last four weeks. Data had to be generated during the daily clinical routine of the physicians. Any change in the patient’s antidiabetic therapy regimen was strictly left at the physician’s discretion. No therapeutic decision of the physician should have been based upon participation in this NIS. Titration algorithm was also left at the investigator’s discretion.
Participating physicians were distributed equally all over Germany to allow for a representative sample of German T1DM and T2DM patients switching their basal insulin component of their BOTplus or BBT regimen.
In order to allow for a valid statistical analysis even in smaller subgroups of patients (as distribution within the predefined subgroups may not be equal), it was planned to document and analyze about 2,500 patients. The planned number of participating sites was 540. Participating doctors were mostly to be diabetologists, as the kind of physician who usually follow-up basal plus prandial insulin therapy in T1DM and T2DM patients in Germany. Also, general practitioners, family physicians and internists (office based) were to be included in the study, if they treat advanced T2DM and T1DM patients. The practices were to be distributed equally all over Germany to allow for geographical representativeness.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Duration (persistency) of response defined as time from start of response to end of response. Beginning of response was defined by time of the first of at least two FBG values below or equal to 110 mg/dL or time of first HbA1c below or equal to predefined individual target value whichever occurred first. End of response was defined as one of the following:
- the second FBG value >110 mg/dL (>6.1 mmol/L) after start of FBG response or
- the first HbA1c value above the individual predefined target or
- change to another form of insulin therapy or change of basal insulin.

Secondary outcome measures

1. Absolute change in HbA1c from baseline to 6 months to 12 months
2. Absolute change in FBG from baseline to 6 months to 12 months
3. Response rate 6 and 12 months after start of insulin glargine 300 U/mL treatment defined by:
- Reaching two FBG values below or equal to 110 mg/dL or at least once the predefined individual HbA1c target value or
- Reaching at least one HbA1c value equal or less to the predefined individual HbA1c
target value OR
- Reaching two FBG values below or equal to 110 mg/dL or
- Reaching two FBG values below or equal to 110 mg/dL and at least once the predefined individual HbA1c target value.
4. Time from start of insulin glargine 300 U/mL treatment to response for each of the response endpoints
5. Incidence rates and rates per patient-year were calculated for symptomatic, confirmed symptomatic, nocturnal, severe, and severe nocturnal hypoglycemia as reported in the electronic Case Report Form (eCRF). Confirmation of symptomatic hypoglycemia was defined
as self-measured blood glucose (SMBG) measurement below or equal to 70 mg/dL. Severe hypoglycemia was defined as necessity of the assistance of another person or an SMBG measurement of below or equal to 56 mg/dL. Nocturnal hypoglycemia occurring during the night (approximately 10pm-6am), while the patient was asleep (symptomatic or confirmed by SMBG measurement below or equal to 70 mg/dL). Severe nocturnal hypoglycemia was defined as those nocturnal hypoglycemia fulfilling the Definition of severe hypoglycemia. 95% CIs for incidence rates were calculated according to Clopper-Pearson. Rates per patient-year were calculated as a cumulative number of hypoglycemia events for all patients divided by the cumulative duration of insulin glargine 300 U/mL therapy in years, whereas patients with missing treatment duration or missing number of hypoglycemic events were excluded.
6. Absolute change in the 4-point blood glucose profile from baseline to 6 months to 12 months
7. Absolute change in body weight from baseline to 6 months to 12 months
8. Absolute change in daily insulin doses (number of units and number of units per kg body weight [BW]) and number of dose modifications per visit.
9. Values and absolute changes for blood lipids (triglycerides, high-density Lipoprotein [HDL], low-density Lipoprotein [LDL] and total cholesterol) from baseline to 6 months to 12 months
10. Type of LLT overall and by LDL subgroups (<70 mg/dL, <100 mg/dL, 100-190 mg/dL, >190 mg/dL at respective visit). An intensification of LLT was defined as administration of an additional LLT drug compared to baseline, or a higher dosing of statin, i.e. change from
moderate at one visit to intensive at a following visit.
11. Patient’s treatment satisfaction, measured by using the Diabetes Treatment Satisfaction Questionnaire (DTSQs) instrument is comprised of eight items. For scoring, six of these items were summed to produce a measure of satisfaction with treatment. The remaining two items (perceived frequency of hyperglycemia and perceived frequency of hypoglycemia) were treated individually. Measured at baseline, 6 months, and 12 months.
12. Safety parameters were incidences of adverse events (AE), related AEs, serious adverse events (SAE), related SAEs and fatal AEs.

Overall trial start date

02/12/2014

Overall trial end date

29/03/2017

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Patients with type 1 diabetes (basal-bolus insulin therapy) or type 2 diabetes (basal insulin plus 1-2x prandial insulin and oral antidiabetic drugs or basal-bolus insulin therapy) with any basal insulin except insulin glargine 300 U/mL.
2. Adults and Seniors: Age at least 18 years, no upper age limit.
3. HbA1c between 7.5% to 10.0%.
4. Fasting blood glucose > 130 mg/dL.
5. Ability and willingness to perform blood glucose self-monitoring.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

2500 participants

Participant exclusion criteria

1. Contraindications for a therapy with insulin glargine 300 U/mL.
2. Patients receiving oral antidiabetic drug therapy only.
3. Patients receiving basal insulin and oral antidiabetic drugs without prandial insulin.
4. Patients with known cancer disease.
5. Pregnancy.
6. Drug or alcohol abuse.
7. Dementia or general incapacity to understand the content of the observational study.

Recruitment start date

11/08/2015

Recruitment end date

31/01/2016

Locations

Countries of recruitment

Germany

Trial participating centre

Herr Dr. Stefan Pscherer
99425
Germany

Trial participating centre

Herr Dr. Frank Ackermann
06108
Germany

Trial participating centre

Frau Dr. Susanne Adler
33332
Germany

Trial participating centre

Herr Dr. Hasan Alawi
66740
Germany

Trial participating centre

Herr Dr. Heiko Ambrosch
06712
Germany

Trial participating centre

Frau Dr. Steffi Appelt
97421
Germany

Trial participating centre

Frau Dr. Kathrin Auerbach
04779
Germany

Trial participating centre

Herr Modjtaba Barghi
12347
Germany

Trial participating centre

Herr Jürgen Bartlewski
76139
Germany

Trial participating centre

Frau Dr. Anna Bartnik‐Mikuta
92237
Germany

Trial participating centre

Herr Dr. Bert Basan
18209
Germany

Trial participating centre

Herr Dr. Bernd Becker
45355
Germany

Trial participating centre

Herr Dr. Sven Becker
99085
Germany

Trial participating centre

Frau Dr. Kerstin Benecke
39104
Germany

Trial participating centre

Herr Dr. Matthias Benecke
06122
Germany

Trial participating centre

Herr Dr. Dirk Berger
31139
Germany

Trial participating centre

Herr Dr. Peter Berndt
45309
Germany

Trial participating centre

Herr Dr. Tasso Bieler
01587
Germany

Trial participating centre

Herr Dr. Ralph Achim Bierwirth
45138
Germany

Trial participating centre

Herr Igor Bolsun
89073
Germany

Trial participating centre

Herr Dr. Beqir Brahimi
47906
Germany

Trial participating centre

Herr Dr. Markus Braun
84489
Germany

Trial participating centre

Frau Dr. Daniela Brugger
83278
Germany

Trial participating centre

Herr Dr. Peter Bühler
88430
Germany

Trial participating centre

Herr Dr. Thomas Bulang
02625
Germany

Trial participating centre

Herr Dr. Klaus Burkhardt
91781
Germany

Trial participating centre

Herr Dr. Ronny Casneuf
30880
Germany

Trial participating centre

Frau Regina‐Monika Chmielewski
58675
Germany

Trial participating centre

Frau Maren Dehne
23879
Germany

Trial participating centre

Frau Dr. Iris Donati‐Hirsch
44137
Germany

Trial participating centre

Herr Dr. Markus Eidenmüller
35037
Germany

Trial participating centre

Herr Dr. Volker Eissing
26871
Germany

Trial participating centre

Frau Dr. Annette Engelhardt
99610
Germany

Trial participating centre

Frau Dr. Friedlinde Ernst
87439
Germany

Trial participating centre

Herr Dr. Franz‐Rudolf Fendler
30171
Germany

Trial participating centre

Frau Manuela Fettig‐Killat
76661
Germany

Trial participating centre

Herr Dr. Albrecht Fießelmann
13597
Germany

Trial participating centre

Herr Dr. Ulrich Flintzer
17033
Germany

Trial participating centre

Herr Frank Franzmann
32549
Germany

Trial participating centre

Frau Dr. Verena Fuhrmann
07545
Germany

Trial participating centre

Herr Dr. Alexander Garcia Godelmann
55130
Germany

Trial participating centre

Herr Dr. Gregor Gauer
01612
Germany

Trial participating centre

Frau Sonja Gericke
19348
Germany

Trial participating centre

Herr Dr. Peter Geßner
76149
Germany

Trial participating centre

Herr Dr. Sebastian Glüer‐Fuchs
30900
Germany

Trial participating centre

Herr Dr. Rainer‐Christian Görne
67433
Germany

Trial participating centre

Herr Kai Götte
61381
Germany

Trial participating centre

Herr Dr. Detlef Götze
39120
Germany

Trial participating centre

Herr Volkart Güntsch
19057
Germany

Trial participating centre

Herr Dirk Haaser
01309
Germany

Trial participating centre

Herr Andreas Hain
36266
Germany

Trial participating centre

Herr Dr. Peter Hainzinger
85057
Germany

Trial participating centre

Herr Dr. Dirk Hennig
01662
Germany

Trial participating centre

Frau Dr. Kerstin Herrmann‐Benecke
06122
Germany

Trial participating centre

Herr Dr. Joachim Hesse
19370
Germany

Trial participating centre

Herr Dr. Christoph Heyer
41747
Germany

Trial participating centre

Frau Dr. Henrike Hilbig
30165
Germany

Trial participating centre

Herr Dr. Roger Hladik
67063
Germany

Trial participating centre

Herr Dr. Hans‐Dieter Hoffmann
58706
Germany

Trial participating centre

Herr Dr. Gerd Hollmann
13439
Germany

Trial participating centre

Frau Susanne Höltz‐Röhrig
55624
Germany

Trial participating centre

Frau Dr. Birgit Höne‐Römmer
04299
Germany

Trial participating centre

Frau Dr. Irina Hort
10318
Germany

Trial participating centre

Herr Christoph Hummel
33602
Germany

Trial participating centre

Herr Dr. Michael Karl Huptas
45307
Germany

Trial participating centre

Herr Dr. Sebastian Huptas
45307
Germany

Trial participating centre

Herr Clemens Huth
47929
Germany

Trial participating centre

Herr Professor Dr. Hans‐Dieter Janisch
91052
Germany

Trial participating centre

Herr Dr. Hans‐Joachim Jonderko
76135
Germany

Trial participating centre

Herr Dr. Hans‐Peter Kempe
67059
Germany

Trial participating centre

Herr Professor Dr. Werner Kern
89073
Germany

Trial participating centre

Frau Dr. Stephanie Kieu
26388
Germany

Trial participating centre

Herr Dr. Andreas Kirsten
01129
Germany

Trial participating centre

Herr Dr. Gerhard Klausmann
63739
Germany

Trial participating centre

Herr Dr. Carsten Klugewitz
45277
Germany

Trial participating centre

Herr Dr. Karsten Knöbel
94315
Germany

Trial participating centre

Frau Dr. Nicole Koch
22041
Germany

Trial participating centre

Herr Dr. Thorsten Koch
22041
Germany

Trial participating centre

Herr Andreas Kochan
02826
Germany

Trial participating centre

Herr Dr. Wolfgang Kohn
13086
Germany

Trial participating centre

Frau Dr. Kerstin König
59174
Germany

Trial participating centre

Herr Dr. Günter Kraus
96117
Germany

Trial participating centre

Frau Katrin Krause
06366
Germany

Trial participating centre

Frau Irmhild Krüger
16928
Germany

Trial participating centre

Frau Dr. Kerstin Kux
49124
Germany

Trial participating centre

Herr Dr. Benedict Lacner
45468
Germany

Trial participating centre

Herr Dr. Bernhard Landers
56727
Germany

Trial participating centre

Herr Dr. Jürgen Landschulze
07768
Germany

Trial participating centre

Frau Dr. Vera Lang
91207
Germany

Trial participating centre

Herr Hendrik Lange
07570
Germany

Trial participating centre

Herr Dr. Harald Letterer
29459
Germany

Trial participating centre

Herr Privatdozent Dr. Ulrich Lotze
06556
Germany

Trial participating centre

Frau Dr. Jenny Luong‐Thanh
26388
Germany

Trial participating centre

Herr Dr. Lam Luong‐Thanh
26388
Germany

Trial participating centre

Frau Dr. Cornelia Marck
35415
Germany

Trial participating centre

Herr Dr. Ekkehard Martin
38165
Germany

Trial participating centre

Herr Dr. Peter Mayr
78333
Germany

Trial participating centre

Herr Dr. Claus Mees
67063
Germany

Trial participating centre

Frau Dr. Martina Meier‐Höfig
24796
Germany

Trial participating centre

Frau Peggy Meyer
13086
Germany

Trial participating centre

Herr Francesco Michelini
41472
Germany

Trial participating centre

Herr Dr. Uwe Milbradt
39387
Germany

Trial participating centre

Herr Dr. Rainer Möllmann
47799
Germany

Trial participating centre

Herr Dr. Joachim Müller
97421
Germany

Trial participating centre

Frau Gabriele Müller‐Hunold
38368
Germany

Trial participating centre

Herr Dr. Axel Müllhofer
88400
Germany

Trial participating centre

Frau Dr. Manuela Nader
82110
Germany

Trial participating centre

Herr Dr. Rainer Naus
87435
Germany

Trial participating centre

Herr Dr. Olaf Ney
31535
Germany

Trial participating centre

Herr Michael Nowotny
02763
Germany

Trial participating centre

Frau Dr. Katrin Ohde
45329
Germany

Trial participating centre

Herr Dr. Tobias Ohde
45329
Germany

Trial participating centre

Frau Dr. Silke Otto‐Hagemann
49377
Germany

Trial participating centre

Herr Dr. Andreas Patzelt
44892
Germany

Trial participating centre

Herr Dr. Johannes Peters
50126
Germany

Trial participating centre

Herr Dr. Gert Pfundt
55130
Germany

Trial participating centre

Herr Dr. Eberhard Politz
38518
Germany

Trial participating centre

Frau Maria Pollok
58675
Germany

Trial participating centre

Frau Stefanie Rasfeld
98574
Germany

Trial participating centre

Herr Björn Reißmann
58730
Germany

Trial participating centre

Frau Dr. Uta Rieger
14482
Germany

Trial participating centre

Herr Dr. Uwe Ritzel
26384
Germany

Trial participating centre

Herr Dr. Tobias Rückert
30165
Germany

Trial participating centre

Frau Dr. Emilia Ruff
97980
Germany

Trial participating centre

Frau Dr. Ursula Ruthe
14532
Germany

Trial participating centre

Herr Dr. Oliver Sauer
02826
Germany

Trial participating centre

Frau Dr. Astrid Sawistowsky
04249
Germany

Trial participating centre

Herr Dr. Jörg Schaper
86470
Germany

Trial participating centre

Herr Privatdozent Dr. Stephan Scharla
83435
Germany

Trial participating centre

Herr Edgar Schaubert
52457
Germany

Trial participating centre

Herr Dr. Thomas Schaum
23758
Germany

Trial participating centre

Herr Dr. Reinhard Schaupp
97762
Germany

Trial participating centre

Herr Dr. Martin Scherwinski
10823
Germany

Trial participating centre

Herr Alois Schießl
22041
Germany

Trial participating centre

Herr Dr. Joachim Schiwietz
49808
Germany

Trial participating centre

Herr Dr. Uwe Schläfer
87439
Germany

Trial participating centre

Herr Oliver Schlott
50126
Germany

Trial participating centre

Herr Heiko Schneider
99510
Germany

Trial participating centre

Frau Dr. Stefanie Schrader
30165
Germany

Trial participating centre

Frau Dr. Sabine Schulze
35043
Germany

Trial participating centre

Herr Toralf Schwarz
04442
Germany

Trial participating centre

Herr Dr. Andreas Schwittay
04564
Germany

Trial participating centre

Frau Dr. Kathrin Seuß
95032
Germany

Trial participating centre

Herr Dr. Andreas Staudenmeyer
49808
Germany

Trial participating centre

Herr Dr. Jörg Steindorf
04435
Germany

Trial participating centre

Frau Dorothea Stottmeister
39307
Germany

Trial participating centre

Herr Dr. Kai Straßmann
42699
Germany

Trial participating centre

Frau Dr. Eva‐Maria Streck
04643
Germany

Trial participating centre

Herr Matthias Strickling
46284
Germany

Trial participating centre

Frau Dr. Danuta Stryjek‐Kaminska
65185
Germany

Trial participating centre

Herr Dr. Werner Stürmer
97080
Germany

Trial participating centre

Herr Dr. Jörg Tafel
61350
Germany

Trial participating centre

Frau Dr. Birgit Teubner
03046
Germany

Trial participating centre

Herr Jörg Thelen
15806
Germany

Trial participating centre

Frau Svetlana Tlechas‐Tkatsch
14480
Germany

Trial participating centre

Herr Thomas Voigt
04654
Germany

Trial participating centre

Herr Wolf Heinrich von Aufseß
95445
Germany

Trial participating centre

Frau Dr. Heike Wagner
47829
Germany

Trial participating centre

Frau Ina Walter
99974
Germany

Trial participating centre

Frau Dr. Daniela Walther
67246
Germany

Trial participating centre

Frau Ingrid Weber
26725
Germany

Trial participating centre

Herr Dr. Norbert Weghmann
52066
Germany

Trial participating centre

Herr Dr. Rolf Weißmann
90411
Germany

Trial participating centre

Herr Dr. Artur Zimmermann
83043
Germany

Trial participating centre

Herr Dr. Stefan Zinn
36341
Germany

Trial participating centre

Herr Dr. Jens Abendroth
06188
Germany

Sponsor information

Organisation

Sanofi-Aventis Deutschland GmbH

Sponsor details

Potsdamer Str. 8
Berlin
D-10785
Germany
+49 (0)30 2575 2502
Cornelia.Dorn@sanofi.com

Sponsor type

Industry

Website

https://www.sanofi.de/

Funders

Funder type

Industry

Funder name

Sanofi-Aventis Deutschland GmbH

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Full publications planned in high-impact peer-reviewed journals:
2 full publications (results for type 1 diabetes and results for type 2 diabetes) planned for Q2/2019.
4 full paper on sub group analyses (age groups, responder, each in type 1 diabetes and type 2 diabetes) are planned for end of 2019.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request

Intention to publish date

30/04/2019

Participant level data

Available on request

Basic results (scientific)

Publication list

Poster abstracts:
1. Pscherer S, Pfohl M, Anderten H, Pegelow K, Seufert J. Nicht-interventionelle Studie zur Untersuchung der Effizienz des Wechsels der Basalinsulinkomponente bei einer BOTplus oder intensivierten Insulintherapie (ICT) zu Insulin glargin 300 E/ml bei Typ-1- und Typ-2-Diabetespatienten mit inadäquater glykämischer Kontrolle. Diabetologie & Stoffwechsel 2016; 11 (Suppl. 1): Abstr. P220. Presented as poster at the 51rst Annual Meeting of the German Diabetes Association (DDG) at 05.05.2016 in Berlin, Germany. Available at: https://doi.org/10.1055/s-0036-1580967
2. Fritsche A, Pscherer S, Pfohl M, Anderten H, Pegelow K, Seufert J. Umstellung des Basalinsulins auf Insulin glargin 300 E/ml (Gla-300) nach Versagen der Basis-Bolus-Therapie (ICT) mit einem anderen Basalinsulin verbesserte bei Typ-1-Diabetespatienten die Blutzucker-Einstellung – 6-Monats-Ergebnisse der Toujeo-Neo-T1DM-Studie. Diabetologie & Stoffwechsel 2018; 13 (Suppl. 1): S61, Abstract P181. Presented as poster at the 53rst Annual Meeting of the German Diabetes Association (DDG) at 11.05.2018 in Berlin, Germany. Available at: https://doi.org/10.1055/s-0038-1641939
3. Pscherer S, Pfohl M, Fritsche A, Anderten H, Pegelow K, Seufert J. Umstellung des Basalinsulins auf Insulin glargin 300 E/ml (Gla-300) nach Versagen einer Basis-Bolus- (ICT) oder einer basalunterstützten oralen Therapie mit einmal täglich prandialem Insulin (BOTplus) mit einem anderen Basalinsulin verbesserte bei Typ-2-Diabetespatienten die glykämische Kontrolle – 6-Monats-Ergebnisse der Toujeo-Neo-T2DM-Studie. Diabetologie & Stoffwechsel 2018; 13 (Suppl. 1): S51-S52, Abstract P153. Presented as poster at the 53rst Annual Meeting of the German Diabetes Association (DDG) at 11.05.2018 in Berlin, Germany. Available at: https://doi.org/10.1055/s-0038-1641911
4. Fritsche A, Pscherer S, Anderten H, Pegelow K, Seufert J, Pfohl M. Switching to Insulin Glargine 300 U/mL (Gla-300) Improves Glycemic Control After Failure of Basal-Bolus Therapy (BBT) With Other Basal Insulins (BI) in patients (pts) with Type 1 Diabetes (T1DM). Diabetes 2018; 67 (Suppl. 1): Abstract 1031-P. Presented as poster at the 78th Scientific Sessions of the American Diabetes Association at 23.06.2018 in Orlando, FL, USA. Available at: https://doi.org/10.2337/db18-1031-P
5. Pscherer S, Fritsche A, Anderten H, Pegelow K, Seufert J, Pfohl M. Switching to Insulin Glargine 300 U/mL (Gla-300) after Failure of Advanced Insulin Therapy (IT) with Other Basal Insulins (BI) in Patients (Pts) with Type 2 Diabetes (T2DM) Improved Glycemic Control. Diabetes 2018; 67 (Suppl. 1): Abstract 2288-PUB (Published only). Available at: https://doi.org/10.2337/db18-2288-PUB

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Editorial Notes

27/02/2019: Trial’s existence confirmed by IRB