- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding
Fase
- Fase 4
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
---|
Frequency of subjects with conventionally detected hypoglycemia
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Wolfgang Landgraf, Dr., Sanofi
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- HOE901_4049
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
produkt fremstillet i og eksporteret fra U.S.A.
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Diabetes mellitus type 2
-
University Hospital Inselspital, BerneAfsluttetType 2 diabetes mellitusSchweiz
-
India Diabetes Research Foundation & Dr. A. Ramachandran...Afsluttet
-
US Department of Veterans AffairsAmerican Diabetes AssociationAfsluttetType 2 diabetes mellitusForenede Stater
-
Dexa Medica GroupAfsluttetType-2 diabetes mellitusIndonesien
-
AstraZenecaRekruttering
-
Daewoong Pharmaceutical Co. LTD.Ikke rekrutterer endnuT2DM (Type 2 Diabetes Mellitus)
-
Zhongda HospitalRekrutteringType 2 diabetes mellitus (T2DM)Kina
-
Newsoara Biopharma Co., Ltd.RekrutteringT2DM (Type 2 Diabetes Mellitus)Kina
-
Shanghai Golden Leaf MedTec Co. LtdAktiv, ikke rekrutterendeType 2 diabetes mellitus (T2DM)Kina
-
SanofiAfsluttet
Kliniske forsøg med Insulin glargin
-
SanofiAfsluttet
-
Johns Hopkins UniversityAfsluttetHypoglykæmi | Type 1 diabetesForenede Stater
-
SanofiAfsluttetDiabetes mellitus type 2Tyskland
-
Novo Nordisk A/SAfsluttetDiabetes mellitus, type 2Tyskland
-
IRCCS San RaffaeleAfsluttetType 2 diabetes mellitus | Perifer vaskulær sygdomItalien
-
SanofiAfsluttet
-
SanofiAfsluttetType 1 diabetes mellitusForenede Stater, Canada, Tjekkiet, Danmark, Estland, Finland, Ungarn, Japan, Letland, Holland, Puerto Rico, Rumænien, Sverige
-
SanofiAfsluttetType 2 diabetes mellitusForenede Stater, Sydafrika, Canada, Tjekkiet, Estland, Finland, Frankrig, Tyskland, Ungarn, Letland, Mexico, Holland, Rumænien
-
SanofiAfsluttetType 2 diabetes mellitusForenede Stater, Finland, Sydafrika, Canada, Mexico, Chile, Spanien, Den Russiske Føderation, Frankrig, Tyskland, Ungarn, Portugal, Rumænien