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The Exploration of Optimal Treatment Scheme in Patients With Type 2 Diabetes Inadequately Controlled With Glargine Fase IV 100 Esercizio

Sconosciuto
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La sperimentazione clinica NCT03659383 è uno studio interventistico di Fase IV volto a esaminare il trattamento per Diabete di Tipo 2, attualmente sconosciuto. Avviato il 20 settembre 2018, prevede di arruolare 100 partecipanti. Sotto la guida di Nanjing First Hospital, Nanjing Medical University, dovrebbe concludersi entro il 31 marzo 2019. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 6 settembre 2018.
Sommario breve
Glargine is commonly used in insulin supplemental therapy in patients with type 2 diabetes(T2D) at present. However, many patients who treated with glargine still have poor blood glucose control because of insufficient insulin dose or improper oral medication. This study aims to investigate the optimal treatment scheme in order to improve the blood control in these patients. Continuous Glucose Monitoring System (CGMS...Mostra di più
Titolo ufficiale

The Exploration of Optimal Treatment Scheme in Patients With Type 2 Diabetes Inadequately Controlled With Glargine

Patologie
Diabete di Tipo 2
Altri ID dello studio
  • KY20170904-03
Numero NCT
NCT03659383
Data di inizio (effettiva)
2018-09-20
Ultimo aggiornamento pubblicato
2018-09-06
Data di completamento (stimata)
2019-03-31
Arruolamento (previsto)
100
Tipo di studio
Interventistico
FASE
Fase IV
Stato
Sconosciuto
Scopo principale
Trattamento
Allocazione
N.D.
Modello di intervento
A gruppo singolo
Mascheramento
Nessuno (studio in aperto)
Bracci / Interventi
Gruppo/Braccio di partecipantiIntervento/Trattamento
SperimentaleOptimal hypoglycemic treatment
The patients will receive optimal hypoglycemic treatments, including adjustment of insulin dose and oral antidiabetic agents
Optimal hypoglycemic treatment
Standardize oral hypoglycemic medication and adjust insulin dose according to blood glucose values obtained by self-monitoring
Esito primario
Misure di esitoDescrizione della misuraArco temporale
Rate of reaching target of glucose
Rate of reaching target of glucose
0-1 month
Esito secondario
Misure di esitoDescrizione della misuraArco temporale
HbA1c
Glycated hemoglobin at baseline and 3 months after reaching target of blood glucose
0-3 month
Dosage of insulin
Change of insulin dose
0-1 month
Time of reaching target of glucose
Time of reaching target of glucose
0-1 month
Criteri di eleggibilità

Età idonea
Bambino, Adulto, Adulto anziano
Sessi idonei
Tutti
  1. Patients with T2DM, which was defined bypublished Criteria of World Health Organization in 1999;
  2. Patients were using glargine with or without oral hypoglycemic drugs and having a stable dose of glargine for more than 2 month would be recruited into this study;
  3. Patients had relatively constant diet and exercise in 2 month before the study.
  4. Fasting blood glucose was between 6.1 and 16mmolL, and postprandial (or random) blood glucose <22.2mmol/L

  1. Patients with severe cardiovascular diseases, such as stroke, transient ischemic attack, myocardial infarction, unstable angina, coronary artery bypass grafting, percutaneous coronary intervention, and heart failure;
  2. Patients with severe infectious diseases;
  3. Patients with acute complications of diabetes on admission, such as diabetic ketoacidosis, diabetic hyperosmolar nonketotic coma, and lactic acidosis;
  4. Patients with history of psychiatric disorders and were unsuitable to use CGMS;
  5. Any other situations that made patients unsuitable to participate in the study, such as alcoholism and drug abuse.
Nanjing First Hospital, Nanjing Medical University logoNanjing First Hospital, Nanjing Medical University
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