Evaluating the True Magnitude of HYPOglycemic Events After THE Initiation of Sulfonylurea
Information source: Institut de Recherches Cliniques de Montreal
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes
Intervention: Observational (Other)
Phase: N/A
Status: Not yet recruiting
Sponsored by: Institut de Recherches Cliniques de Montreal Overall contact: Rémi Rabasa-Lhoret, MD, PhD, Phone: 514-987-5666, Email: remi.rabasa-lhoret@ircm.qc.ca
Summary
Gliclazide formulations are known to be associated with a lower incidence of hypoglycaemia
than glyburide, a characteristic that could impact the choice of second and third line
therapy. However, little is known about the frequency of asymptomatic or unreported
hypoglycemia and their impact on glycemic control and quality of life among patients using
these sulfonylureas (SUs). Even with such agents, 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 gliclazide and gliclazide modified release (MR) 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 gliclazide or gliclazide MR. 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 with gliclazide or gliclazide MR,
including medical history measures, quality of life and diabetes treatment satisfaction.
In patients with T2DM already stabilized on metformin but not at goal (A1c >7. 0 mmol/L), and
newly prescribed gliclazide or gliclazide MR, 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.
Clinical Details
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 design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Total incidence rate of hypoglycemia episodeTotal incidence rate of hypoglycemia episode
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Type 2 diabetes according to Canadian Diabetes Association definition
- Initiation of gliclazide or gliclazide MR at baseline
- Currently treated with stable metformin monotherapy (≥3 months)
- A1c: 7. 0% to 10. 0%
- Willing and able to comply with study procedures
Exclusion Criteria:
- Current or previous usage of any other type of antihyperglycemic medication except
metformin
- 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
Locations and Contacts
Rémi Rabasa-Lhoret, MD, PhD, Phone: 514-987-5666, Email: remi.rabasa-lhoret@ircm.qc.ca Additional Information
Starting date: September 2015
Last updated: June 26, 2015
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