Clinical trial NCT02485132: Evaluating the True Magnitude of HYPOglycemic Events After THE Initiation of Sulfonylurea
Official title: Evaluating the True Magnitude of HYPOglycemic Events After THE Initiation of Sulfonylurea, by Continuous Glucose monItoring System: A Multicenter Study. The HYPOTHESIS Trial
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Type 2 Diabetes
Keywords: Type 2 diabetes
Sulfonylurea
Hypoglycemia
Quality of life
Lead sponsor: Institut de Recherches Cliniques de Montreal
Sponsor class: OTHER
First posted: 2015-06-30
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: T2DM not at goal (A1c \>7.0 mmol/L), and newly prescribed a SU

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Total incidence rate of hypoglycemia episode
timeFrame: One week after initiation of the SU
measure: Total incidence rate of hypoglycemia episode
timeFrame: One week at 3-month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University of Toronto
state: Ontario
city: Montreal
country: Canada
facility: Institut de recherches cliniques de Montréal
state: Quebec
Study officials:
affiliation: IRCM
name: Rémi Rabasa-Lhoret, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: