- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00354939
Insulin Analogue With Continuous Glucose Monitoring System (CGMS) Measurement (SAFIR)
10-week, Open, National, Multicenter Clinical Trial to Evaluate the Safety of Insulin Glargine in Type 2 Diabetes Mellitus Patients, on Intensified Conventional Therapy (ICT)
Primary objective:
Difference in frequency of subjects with conventionally detected hypoglycemia by the subject [at least one measurement smaller/equal 60mg/dl documented in the 8-point profile in the case record form (CRF) or documentation of symptomatic hypoglycemia in the CRF through Visits 8/9] compared to CGMS detected blood glucose values smaller/equal 60mg/dl during CGMS measurements (at least one measurement through Visits 8/9) after eight weeks of treatment with insulin glargine.
Secondary objective:
Secondary study objectives were to investigate the safety and efficacy of a treatment change to insulin glargine in ICT treated subjects in terms of:
- Percentage of blood glucose measurements(CGMS data)smaller/equal 60mg/dl [3.3 mmol/l].
- Percentage of nocturnal blood glucose measurements(CGMS data)smaller/equal 60mg/dl[3.3 mmol/l].
- Percentage of daytime blood glucose measurements(CGMS data)smaller/equal 60mg/dl[3.3 mmol/l].
- Area under the curve (AUC smaller/equal 60)and time(t smaller/equal 60)for blood glucose smaller/equal 60mg/dl[3.3mmol/l], area under the curve (AUC greater/equal 180)and time (t greater/equal 180) for blood glucose greater/equal 180mg/dl[10.0mmol/l].
- Area under the curve (AUC smaller/equal 60)and time(t smaller/equal 60)for blood glucose smaller/equal 60mg/dl[3.3mmol/l]during the day (AUC 06.00am - 10.00pm)and during the night(AUC 10.00pm - 06.00am).
- Area under the curve (AUC greater/equal 180)and time(t greater/equal 180)for blood glucose greater/equal 180mg/dl[10.0mmol/l]during the day (AUC 06.00am - 10.00pm)and during the night(AUC 10.00pm - 06.00am).
- Frequency of subjects with nocturnal blood glucose value smaller/equal 60mg/dl[3.3 mmol/l].
- Frequency of subjects with asymptomatic nocturnal blood glucose smaller/equal 60mg/dl[3.3 mmol/l].
- Frequency of subjects with symptomatic nocturnal blood glucose smaller/equal 60mg/dl [3.3 mmol/l].
- Frequency of subjects with daytime blood glucose smaller/equal 60mg/dl [3.3 mmol/l].
- Frequency of subjects with asymptomatic daytime blood glucose smaller/equal 60mg/dl[3.3 mmol/l].
- Frequency of subjects with symptomatic daytime blood glucose smaller/equal 60mg/dl[3.3 mmol/l].
- Frequency of subjects with hyperglycemic blood glucose(greater/equal 180mg/dl,[10.0mmol/l]).
- Frequency of subjects with symptomatic hypoglycemia(smaller/equal 60mg/dl [3.3mmol]).
- Frequency of subjects with severe hypoglycemia(smaller/equal 36mg/dl [2.0mmol/l]).
- Blood glucose values of 8-point profiles.
- Mean daytime & mean nocturnal blood glucose of 8-point-profiles.
- HbA1c.
- Fasting blood glucose (FBG).
- Dose of insulin.
- Adjustment of insulin.
- Body weight, body mass index.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription
Phase
- Phase 4
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Subjects with type 2 diabetes mellitus (no history of ketoacidosis)and stable treatment with NPH insulin(once or twice daily)and mealtime insulin for at least 3 months.
- HbA1c values smaller/equal 8.0%(measured at screening visit, Visit 1).
- Ability and willingness to perform continuous and self monitoring blood glucose profiles, using a self monitoring blood glucose meter as well as carrying the continuous blood glucose meter at least two times for 72 hours throughout the study at home.
Exclusion Criteria:
- All forms of diabetes other than type 2 diabetes mellitus.
- Oral antidiabetic drugs(OADs)and/or insulins other than NPH and mealtime insulins, except metformin(stable dose for a minimum of 3 months, no dose adjustments during the study).
- Pregnant(as determined by urine pregnancy test at Visit 1)or breast-feeding.
- Women of childbearing potential who did not take adequate contraceptive protection such as systemic hormones or who planned to become pregnant during the study.
- Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol (e.g. systemic corticosteroids).
- History of hypersensitivity to the study medication or to drugs with similar chemical structures.
- Treatment with any investigational drugs in the last month before study entry.
- History of drug or alcohol abuse.
- Diabetic retinopathy with surgical treatment (laser photocoagulation or vitrectomy) in the 3 months prior to study entry or which required surgical treatment within the study.
- Clinically relevant cardiovascular, gastrointestinal, hepatic, neurological, endocrine, hematological or other major systemic diseases making implementation of the protocol or interpretation of the study results difficult.
- Known impaired hepatic or renal function.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
---|
Frequency of subjects with conventionally detected hypoglycemia
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Wolfgang Landgraf, Dr., Sanofi
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- HOE901_4049
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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