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SanofiA Study to Evaluate the Effectiveness and Safety Initiation and Titration of Insulin Glargine (U300) in Insulin-naïve Patients With Type 2 Diabetes Mellitus (T2DM) Controlled on Oral Antidiabetic Drug Treatment in Turkey (EASE) Phase 4 112
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Die klinische Studie NCT02954692 (EASE) untersuchte Behandlung im Zusammenhang mit Typ-2-Diabetes mellitus. Diese interventionsstudie der Phase 4 hat den Status abgeschlossen. Die Studie begann am 30. November 2016 mit 112 Teilnehmern. Sie wurde durchgeführt von Sanofi und am 22. Dezember 2017 abgeschlossen. Die Daten von ClinicalTrials.gov wurden zuletzt am 14. Januar 2019 aktualisiert.
Kurzbeschreibung
Primary Objective:
To assess the mean change in HbA1c (glycated haemoglobin).
Secondary Objectives:
To evaluate the efficacy and safety of the titration of insulin glargine U300 in terms of:
- Targeted HbA1c;
- Targeted fasting self- monitoring blood glucose (SMBG);
- Hypoglycemic events;
- Adverse events;
- Quality of life assessment by DTSQs (Diabetes Treatment Satisfaction Questionnaire status) and DTSQc (Diab...
Ausführliche Beschreibung
The total study duration per patient will be 27 weeks (2 weeks of screening, 24 weeks on treatment, and 1 week follow-up period).
Offizieller Titel
A National, Multicenter, Prospective, Interventional, Open-label, Single-arm, 24-Week Phase IV Study to Evaluate the Effectiveness and Safety of Initiation and Titration of Insulin Glargine U300 in Insulin-naïve Patients With T2DM Inadequately Controlled on OAD Treatment in Turkey
Erkrankungen
Typ-2-Diabetes mellitusWeitere Studien-IDs
- EASE
- GLARGL07921
- U1111-1183-8755 (Andere Kennung) (UTN)
NCT-Nummer
Studienbeginn (tatsächlich)
2016-11-30
Zuletzt aktualisiert
2019-01-14
Studienende (vorauss.)
2017-12-22
Geplante Rekrutierung
112
Studientyp
Interventionsstudie
PHASE
Phase 4
Status
Abgeschlossen
Primäres Ziel
Behandlung
Zuteilungsmethode
Nicht zutreffend
Interventionsmodell
Einarmige Studie
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
ExperimentellInsulin glargine (U300) Insulin glargine (U300) will be administered daily through subcutaneous injection, and thereafter, dose will be titrated weekly (preferably 3-4 days) as needed. Background non-insulin anti-diabetic drugs approved for use in combination with insulin according to local labelling, will be permitted, with the exception of Thiazolidinediones (TZDs), which must be stopped at the time of basal insulin initiation. | INSULIN GLARGINE (U300) Pharmaceutical form: pen for injection
Route of administration: subcutaneous Metformin Pharmaceutical form: tablet
Route of administration: oral sulfonylurea Pharmaceutical form: tablet
Route of administration: oral meglitinides Pharmaceutical form: tablet
Route of administration: oral thiazolidinediones Pharmaceutical form: tablet
Route of administration: oral alpha-glucosidase inhibitors Pharmaceutical form: tablet
Route of administration: oral GLP1 Receptor Agonist Pharmaceutical form: pen for injection
Route of administration: subcutaneous Dipeptidyl peptidase-IV (DPP-IV) inhibitors Pharmaceutical form: tablet
Route of administration: oral Sodium-glucose transport-2 (SGLT-2) inhibitors Pharmaceutical form: tablet
Route of administration: oral |
Hauptergebnismessungen
Nebenergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Mean change from baseline in HbA1c | Baseline, Week 24 |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Percentage of patients achieving targeted fasting self-monitored blood glucose (SMBG) without experiencing severe and/or confirmed hypoglycemia ≤70mg/dL and <54 mg/dL | At Weeks 12 and 24 | |
Percentage of patients reaching targeted fasting SMBG (80-130 mg/dL) | At Weeks 12 and 24 | |
Duration to reach target pre-breakfast SMBG | Baseline, Week 24 | |
Mean change from baseline in HbA1c | Baseline, Week 12 | |
Mean change from baseline in SMBG | Baseline, Weeks 12, and 24 | |
Mean change from baseline in fasting plasma glucose (FPG) | Baseline, Weeks 12, and 24 | |
Mean change from baseline in Diabetes Treatment Satisfaction Questionnaire (DTSO) scores | Baseline, Week 24 |
Eignungskriterien
Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle
- Adult patients with type 2 diabetes mellitus (≥18 years of age).
- Type 2 diabetes mellitus diagnosis ≥1 year.
- Treated with ≥1 oral antidiabetics (±glucagon like peptid-1 (GLP-1) analogue) without insulin, for at least 6 months and HbA1c level between 8-11% (insulin-naïve).
- Stable antidiabetic treatment for at least 3 months.
- Willingness to adherence to treatment and titration (including self-injection, self- monitoring blood glucose \[SMBG\]).
- Signed informed consent obtained.
- Age <18 years old.
- Type 1 diabetes mellitus.
- Having secondary type 2 diabetes mellitus.
- Use of any insulin therapy including premix, basal plus/basal bolus regimen from the diagnosis.
- History of hypoglycemia unawareness.
- Known hypersensitivity/intolerance to insulin glargine or any of its excipients.
- Have any condition (including known substance or alcohol abuse or psychiatric disorder) that precludes the patient from following and completing the study protocol.
- Use of systemic glucocorticoids for two weeks or more within 12 weeks prior to the time of screening.
- Pregnant or lactating women.
- Participation in another clinical trial.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
SanofiKeine Kontaktdaten vorhanden
1 Studienstandorte in 1 Ländern
Turkey, Turkey (Türkiye)