- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT02485132
Evaluating the True Magnitude of HYPOglycemic Events After THE Initiation of Sulfonylurea
Evaluating the True Magnitude of HYPOglycemic Events After THE Initiation of Sulfonylurea, by Continuous Glucose monItoring System: A Multicenter Study. The HYPOTHESIS Trial
Sulfonylurea are known to be associated with a risk of hypoglycaemia. However, little is known about the real frequency of asymptomatic or unreported hypoglycemia and their impact on glycemic control and quality of life among patients using sulfonylureas (SUs). The frequency of hypoglycemia is probably underestimated since self-monitoring of blood glucose (SMBG) fail to identify asymptomatic episodes, especially among patients with higher risk of hypoglycemia unawareness (longer diabetes duration, elderly, recurrent hypoglycemia, etc.). No previous studies have reported total hypoglycemia as measured by continuous glucose monitoring system (CGMS) in a large group of Canadians, therefore underestimating the true incidence of these events. As with age hypoglycemia perception is reduced and consequences can be increased due to frailty, elderly could be especially sensitive to the risk of hypoglycemia. Documentation of the total number of hypoglycemia is a relevant objective to really appreciate the potential impact of SUs in the Canadian context.
The investigators propose a multicenter observational prospective study in order to study the incidence of hypoglycaemia measured by CGMS among patients with type 2 diabetes mellitus (T2DM) newly prescribed a SU. The investigators propose to perform a baseline testing (pre-initiation of the SU), at initiation (first week after the first dose of the SU) and after a 3 months follow-up of treatment, including medical history measures, quality of life and diabetes treatment satisfaction.
In patients with T2DM not at goal (A1c >7.0 mmol/L), and newly prescribed a SU, the objectives and hypotheses of the study are to estimate the incidence rate of hypoglycaemia as measured by continuous glucose monitoring system (CGMS) over a total of 3 weeks period following the initiation of the SU.
Studie Overzicht
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
-
-
Ontario
-
Toronto, Ontario, Canada, M5C2T2
- University of Toronto
-
-
Quebec
-
Montreal, Quebec, Canada, H2W1R7
- Institut de recherches cliniques de Montréal
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
- Type 2 diabetes according to Canadian Diabetes Association definition
- Initiation of a SU at baseline
- A1c: 7.0% to 10.0%
- Willing and able to comply with study procedures
Exclusion Criteria:
- Current or previous usage (during the last 3 months) of insulin or repaglinide
- Use of medication known to interfere with glucose metabolism
- Insulin requiring patient: catabolic state and/or ketonuria
- Currently using CGMS or within the last 3 months
- Recent severe hypoglycemia (<3 months)
- Pregnancy or breast-feeding
- Limited life expectancy, high level of functional dependency, extensive coronary disease at high risk of short term ischemic events or multiple major co-morbidities
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
T2DM at SU initiation
T2DM newly prescribed a SU
|
Investigators propose to perform a one-week baseline testing (pre-initiation of the SU), at initiation (first week after the first dose of the SU) and after a 3 months follow-up of treatment with a SU, including CGMS reading, medical history measures, quality of life and diabetes treatment satisfaction.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Total incidence rate of hypoglycemia episode
Tijdsspanne: One week after initiation of the SU
|
One week after initiation of the SU
|
|
Total incidence rate of hypoglycemia episode
Tijdsspanne: One week at 3-month follow-up
|
One week at 3-month follow-up
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Rémi Rabasa-Lhoret, MD,PhD, IRCM
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- HYPOTHESIS
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .