- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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Ontario
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Toronto, Ontario, Kanada, M5C2T2
- University of Toronto
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Quebec
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Montreal, Quebec, Kanada, H2W1R7
- Institut de recherches cliniques de Montréal
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
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T2DM at SU initiation
T2DM newly prescribed a SU
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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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Total incidence rate of hypoglycemia episode
Tidsram: One week after initiation of the SU
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One week after initiation of the SU
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Total incidence rate of hypoglycemia episode
Tidsram: One week at 3-month follow-up
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One week at 3-month follow-up
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Samarbetspartners och utredare
Utredare
- Huvudutredare: Rémi Rabasa-Lhoret, MD,PhD, IRCM
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- HYPOTHESIS
Plan för individuella deltagardata (IPD)
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